Efficacia della clown terapia sul dolore procedurale nei bambini con paralisi cerebrale. Revisione sistematica e meta-analisi
10.54103/dn/18716
BACKGROUND:Nearly 10% of the pain that affects children with cerebral palsy (CP) results from a medical procedure. Clown therapy is a popular distraction technique to reduce pain; some systematic reviews evaluate the efficacy of this intervention in the pediatric setting, but none on children with CP.
AIM:To evaluate the effect of clown therapy on procedural pain in children with CP.
METHODS:Systematic review with meta-analysis of clinical trials with control group. Retrieval of studies by querying biomedical databases, online resources and trial registers. Clown therapy was compared with standard care. The primary outcome was the pain level after surgery. The risk of bias was assessed with RoB 2. Effect size was calculated with a random effects model.
RESULTS:Three studies with 164 patients were included. The risk of bias is high for two studies and raises some concerns for one. All studies analyzed the effect of clown therapy on procedural pain after botulinum toxin injection. There was a statistically non significant reduction in pain in the intervention group compared to the control group (SMD: -0.20, 95% CI: -0.56, 0.17). The heterogeneity between studies is high.
CONCLUSION:Clown therapy for procedural pain from botulinum toxin injections in children with CP seems effective but the methodological limitations of the studies do not allow a definitive judgment. There is a lack of studies evaluating the effect of the intervention on other procedures that children with CP undergo periodically.
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Viviana Fusetti
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Dissertation Nursing
paralisi cerebrale
Efficacia della clown terapia sul dolore procedurale nei bambini con paralisi cerebrale. Revisione sistematica e meta-analisi
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2023-01-30
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Viviana Fusetti
2023/01/30
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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Cummins D, Kerr C, McConnell K, Perra O. Risk factors for intellectual disability in children with spastic cerebral palsy. Arch Dis Child 2021;106(10):975-80. doi: 10.1136/archdischild-2020-320441.
Effectiveness of clown therapy on procedural pain in children with cerebral palsy. A meta-analysis
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                                                                                                                        DOI: 10.54103/dn/18716




             DISSERTATION NURSING
             Journal Homepage: https://riviste.unimi.it/index.php/dissertationnursing
Systematic Review & Meta-Analysis

         Effectiveness of clown therapy on procedural pain in
             children with cerebral palsy. A meta-analysis
                        1
Luca Giuseppe Re          , Viviana Fusetti 2
1 ASST   Grande Ospedale Metropolitano Niguarda, Milan, Italy
2 Fondazione  IRCCS Istituto Nazionale dei Tumori, Milan, Italy



Findings:                                                ABSTRACT
Although the results of the included studies             BACKGROUND: Nearly 10% of the pain that affects children with
seem promising, substantial heterogeneity and            cerebral palsy (CP) results from a medical procedure. Clown therapy is a
the risk of bias indicate the need for more
rigorous studies in this direction.
                                                         popular distraction technique to reduce pain; some systematic reviews
                                                         evaluate the efficacy of this intervention in the pediatric setting, but none on
                                                         children with CP.

                                                         AIM: To evaluate the effectiveness of clown therapy on procedural pain in
                                                         children with CP.

                                                         METHODS: Systematic review with meta-analysis of clinical trials with
                                                         control group. Retrieval of studies by querying biomedical databases, online
                                                         resources and trial registers. Clown therapy was compared with standard
                                                         care. The primary outcome was the pain level after surgery. The risk of bias
                                                         was assessed with RoB 2. Effect size was calculated with a random effects
                                                         model.

                                                         RESULTS: Three studies with 164 patients were included. The risk of bias
                                                         is high for two studies and raises some concerns for one. All studies analyzed
                                                         the effect of clown therapy on procedural pain after botulinum toxin
                                                         injection. There was a statistically non significant reduction in pain in the
                                                         intervention group compared to the control group (SMD: -0.20, 95% CI: -
                                                         0.56, 0.17). The heterogeneity between studies is high.

                                                         CONCLUSION: Clown therapy for procedural pain from botulinum toxin
                                                         injections in children with CP seems effective but the methodological
                                                         limitations of the studies do not allow a definitive judgment. There is a lack
                                                         of studies evaluating the effect of the intervention on other procedures that
                                                         children with CP undergo periodically.



                                  KEYWORDS: Clown Therapy, Procedural Pain, Children, Cerebral Palsy




         Corresponding author:                                             43                                  Submission received: 21/09/2022
         Luca Giuseppe Re - luca.re@unimi.it                                                            End of Peer Review process: 21/10/2022
         Padiglione 6, ala C, Piano 1°                                                                                   Accepted: 11/11/2022
         Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                                     This work is licensed under a Creative Commons
           Dissertation Nursing V.2, N.1 (30/01/2023)                                Attribution-NonCommercial-NoDerivatives 4.0 nternational
                                                                                                                        DOI: 10.54103/dn/18716




             DISSERTATION NURSING
             Journal Homepage: https://riviste.unimi.it/index.php/dissertationnursing

Revisione Sistematica & Meta-analisi

   La Clown terapia per il dolore procedurale nei bambini con
     paralisi cerebrale. Revisione sistematica e Meta-analisi
                        1
Luca Giuseppe Re          , Viviana Fusetti 2
1 ASST   Grande Ospedale Metropolitano Niguarda, Milano
2 Fondazione  IRCCS Istituto Nazionale dei Tumori, Milano



Riscontri:                                               ABSTRACT
Nonostante i risultati degli studi inclusi siano         BACKGROUND: Quasi il 10% del dolore che colpisce i bambini con paralisi
promettenti, una forte eterogeneità ed il rischio        cerebrale (PC) deriva da una procedura medica. La clown terapia è una diffusa
di bias indicano la necessità di studi più
rigorosi in questa direzione.
                                                         tecnica di distrazione per ridurre il dolore; alcune revisioni sistematiche
                                                         valutano l'efficacia di questo intervento in ambito pediatrico, ma nessuna su
                                                         bambini con PC.

                                                         OBIETTIVO: Valutare l'effetto della clown terapia sul dolore procedurale
                                                         nei bambini con PC.

                                                         METODI: Revisione sistematica con meta-analisi di trial clinici con gruppo
                                                         di controllo. Reperimento degli studi tramite interrogazione di database
                                                         biomedici, risorse online e registri di trial. La clown terapia è stata confrontata
                                                         con le cure standard. L'esito primario era il livello di dolore dopo l'intervento.
                                                         Il rischio di bias è stato valutato con RoB 2. La dimensione d'effetto è stata
                                                         calcolata con un modello a effetti casuali.

                                                         RISULTATI: Tre studi con 164 pazienti sono stati inclusi. Il rischio di bias è
                                                         alto per due studi e solleva qualche dubbio per uno. Tutti gli studi hanno
                                                         analizzato l'effetto della clown terapia sul dolore procedurale dopo l'iniezione
                                                         di tossina botulinica. È stata rilevata una riduzione statisticamente non
                                                         significativa del dolore nel gruppo di intervento rispetto a quello di controllo
                                                         (DSM: -0,20, IC 95%: -0,56, 0,17). L'eterogeneità tra gli studi è elevata.

                                                         CONCLUSIONE: La clown terapia per il dolore procedurale da iniezioni di
                                                         tossina botulinica nei bambini con PC sembra efficace ma i limiti metodologici
                                                         degli studi non consentono un giudizio definitivo. Mancano studi che valutino
                                                         l'effetto dell’intervento su altre procedure a cui si sottopongono
                                                         periodicamente i bambini con PC.




                              KEYWORDS: Clown Terapia, Dolore Procedurale, Bambini, Paralisi Cerebrale


         Corresponding author:                                             44                                  Submission received: 21/09/2022
         Luca Giuseppe Re - luca.re@unimi.it                                                            End of Peer Review process: 21/10/2022
         Padiglione 6, ala C, Piano 1°                                                                                   Accepted: 11/11/2022
         Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                                     This work is licensed under a Creative Commons
           Dissertation Nursing V.2, N.1 (30/01/2023)                                Attribution-NonCommercial-NoDerivatives 4.0 nternational
                                                                                                         DOI: 10.54103/dn/18716




          DISSERTATION NURSING
          Journal Homepage: https://riviste.unimi.it/index.php/dissertationnursing



BACKGROUND                                                        help young patients meet their need for interaction
                                                                  and support their emotional expression; they also
         Cerebral palsy (CP) includes a group of                  enhance coping skills for optimal management of
neurological disorders that affect an individual's                procedural pain, anxiety and fear [34]. The efficacy of
movement, posture, and balance [1]. In about nine                 the intervention finds its physiological rationale from
out of ten cases, the etiology can be traced back to              the experimental observation that fun and laughter
the perinatal period [2]; it is the most frequent cause           stimulate the production of beta-endorphins, which
of childhood physical disability and affects about 2-3            have strong analgesic and excitatory properties and an
children per 1000 live births [3-8]. CP results in                anesthetizing effect similar to morphine and opioid
movement disorders (spasticity, dystonia) [9, 10] and             substances [35]. Clown therapy in pediatric settings is
includes chronic pain, cognitive disorders [11, 12],              an increasingly popular intervention; attention to this
deficits in speech and vision [13], behavioral                    distraction technique is evidenced by the presence of
problems, and seizures [14, 15]. Pain affects 67-84%              several systematic reviews evaluating its effectiveness
of individuals [11, 16-18]; despite multiple causes [12,          [36-41]. However, there are no known reviews
13, 19], it generally results from spastic muscle                 focused on the effect of the intervention for
contractions [20, 21]. Procedures that children with              procedural pain in children with CP.
CP undergo periodically to improve motor
performance and reduce pain can exacerbate the
symptom and increase discomfort [17, 22, 23, 24, 25]:             AIM
nearly 10% of the pain they experience results from                      To test the effectiveness of clown therapy on
procedures [26]. Even in children with CP, diagnostic             procedural pain in children with CP.
or therapeutic procedures may cause pain, anxiety, or
fear [27] but in addition they have greater need for
repeated treatment over time and, if with intellectual            METHODS
disability, have difficulty communicating pain [28].
                                                                  Inclusion criteria
Quality health care must be able to address and
                                                                          Randomized, quasi-randomized, or non
manage procedural pain [29] in order to produce a
                                                                  randomized clinical trials with control group on the
positive effect on anticipatory anxiety [30]. Short- and
                                                                  effect of clown therapy for procedural pain of
long-term      psychological       consequences      and
                                                                  children with CP were included. Inclusion criteria
unsatisfactory adherence to care may occur in cases of
                                                                  were (1) participants: pediatric subjects with CP
suboptimal symptom management [31, 32]. Children's
                                                                  undergoing medical procedures; (2) intervention:
acute pain should first be addressed by resorting to
                                                                  clown therapy clown doctors; (3) control: standard of
nonpharmacological interventions such as distraction
                                                                  care (parent support ± other distraction techniques ±
techniques [33]. These include clown therapy,
                                                                  analgesia or sedation); (4) outcome: (a) primary:
implemented by people who have undergone specific
                                                                  procedural pain; (b) secondary: child and/or parent
training (clown doctors) who through a clown suit
                                                                  anxiety; (5) care setting: any.
establish a relationship with children who are
hospitalized. Through play and fun, clown doctors

      Corresponding author:                                  45                                 Submission received: 21/09/2022
      Luca Giuseppe Re - luca.re@unimi.it                                                End of Peer Review process: 21/10/2022
      Padiglione 6, ala C, Piano 1°                                                                       Accepted: 11/11/2022
      Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                      This work is licensed under a Creative Commons
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Search strategy                                                                               To retrieve other recently completed studies,
The review protocol was registered with the                                          the following registries were consulted: International
International Prospective Register of Systematic                                     Clinical Trials Registry Platform (ICTRP),
Reviews (PROSPERO) (ID: CRD42022325956). The                                         ClinicalTrials.gov, International Standard Randomised
search for papers of interest was performed until June                               Controlled Trial Number (ISRCTN) registry, EU
2, 2022 on the biomedical databases Cochrane
                                                                                     Clinical Trials Register Bibliographies of relevant
Library,    MEDLINE,          CINAHL,       EMBASE,
                                                                                     reviews and eligible studies were searched. The
PsycINFO, Web of Science, Scopus. The keywords
                                                                                     corresponding authors of the latter were contacted by
used were "cerebral palsy" associated with pain and
"medical clown," "clown therapy," clowning, clown,                                   e-mail to find out if they knew of other studies of
"clown doctor," and "hospital clown" (Table 1). No                                   interest not intercepted by our search. Finally, the
language or publication date limits were applied.                                    leading journals in the field and those that published
                                                                                     the eligible studies were consulted.
       The search was also extended to these online
resources: LILACS, sciELO, CNKI, BASE, TRIP
Medical Database.

   Cochrane Library    MEDLINE            EMBASE                CINAHL         PsycINFO            Web of Science                Scopus
   #1 (“cerebral       #1 “cerebral       #1 ‘cerebral palsy’   #1 “cerebral   #1 “cerebral        #1 “cerebral palsy” (All      #1 TITLE-ABS-KEY
   palsy”)             palsy”                                   palsy”         palsy”.mp           Fields)                       (“cerebral palsy”)
   #2 (pain)           #2 pain            #2 pain               #2 pain        #2 pain.mp          #2 pain (All Fields)          #2 TITLE-ABS-KEY (pain)
   #3 (clown)          #3 clown           #3 clown              #3 clown       #3 clown.mp         #3 clown (All Fields)         #3 TITLE-ABS-KEY (clown)
   #4 (clowning)       #4 clowning        #4 clowning           #4 clowning    #4 clowning.mp      #4 clowning (All Fields)      #4 TITLE-ABS-KEY
                                                                                                                                 (clowning)
   #5 (clowntherapy) #5                   #5 clowntherapy    #5                #5                  #5 clowntherapy (All          #5 TITLE-ABS-KEY
                     clowntherapy                            clowntherapy      clowntherapy.mp     Fields)                       (clowntherapy)
   #6 (“clown        #6 “clown            #6 'clown therapy' #6 "clown         #6 "clown           #6 "clown therapy" (All       #6 TITLE-ABS-KEY ("clown
   therapy”)         therapy”                                therapy"          therapy".mp         Fields)                       therapy")
   #7 (“medical      #7 “medical          #7 'medical        #7 "medical       #7 "medical         #7 "medical clown" (All       #7 TITLE-ABS-KEY ("medical
   clown”)           clown”               clown'             clown"            clown".mp           Fields)                       clown")
   #8 (“hospital     #8 “hospital         #8 'hospital       #8 "hospital      #8 "hospital        #8 "hospital clown" (All      #8 TITLE-ABS-KEY ("hospital
   clown”)           clown”               clown'             clown"            clown".mp           Fields)                       clown")
   #9 (“clown        #9 “clown            #9 'clown doctor' #9 "clown          #9 "clown           #9 "clown doctor" (All        #9 TITLE-ABS-KEY ("clown
   doctor”)          doctor”                                 doctor"           doctor".mp          Fields)                       doctor")
   #10               #10                  #10                #10               #10                 #10                           #10
   #3 OR #4 OR #5 #3 OR #4 OR             #3 OR #4 OR #5 #3 OR #4 OR           #3 OR #4 OR #5      #3 OR #4 OR #5 OR             #3 OR #4 OR #5 OR #6 OR
   OR #6 OR #        #5 OR #6 OR          OR #6 OR #         #5 OR #6 OR       OR #6 OR # 7OR      #6 OR # 7OR # 8 OR            # 7OR # 8 OR #9
   7OR # 8 OR #9     # 7OR # 8 OR         7OR # 8 OR #9      # 7OR # 8 OR      # 8 OR #9           #9
                     #9                                      #9
   #11               #11                  #11                #11               #11                 #11                           #11
   #1 AND #2         #1 AND #2            #1 AND #2          #1 AND #2         #1 AND #2 AND       #1 AND #2 AND #10             #1 AND #2 AND #10
   AND #10           AND #10              AND #10            AND #10           #10
                                                                    Table 1: Search strategy.

Study selection and data extraction                                                  standardized template, the authors independently
        Independently, the authors performed                                         extracted the following data and information: first
querying of biomedical databases and online                                          author and year, study design, country, setting,
resources, screening of records by title and abstract,                               procedure,     participants,     exclusion     criteria,
and in controversial cases also of full-text. Any                                    intervention, control, primary outcome and
disagreements were resolved through comparison and                                   evaluation method, results, any additional notes.
discussion. From each eligible study, through a
       Corresponding author:                                                   46                                   Submission received: 21/09/2022
       Luca Giuseppe Re - luca.re@unimi.it                                                                   End of Peer Review process: 21/10/2022
       Padiglione 6, ala C, Piano 1°                                                                                          Accepted: 11/11/2022
       Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                                          This work is licensed under a Creative Commons
        Dissertation Nursing V.2, N.1 (30/01/2023)                                        Attribution-NonCommercial-NoDerivatives 4.0 nternational
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Risk of bias                                                      Publication bias
         Independently, the risk of bias was assessed                     Inspection of the funnel plot [48] and
with the Risk of Bias 2 (RoB 2) tool [42]. Graphical              application of the Trim and Fill method [49] on it in
restitution was performed with the Risk-of-bias                   the case of a meta-analysis with at least five studies
VISualization (robvis) tool [43].                                 was planned in order to check for publication bias
                                                                  risk. Objective assessment of publication bias was
Data analysis and synthesis                                       carried out using Egger's test [50] and Begg and
        The extracted data were analyzed with                     Mazumdar's test [51]. The study was conducted and
ProMeta© Version 3.0 software. Overall effect size                presented in accordance with PRISMA guidelines
calculation was performed with a random effects                   [52].
model and the creation of forest plots in the case of
at least two studies for each outcome. Standardized               Summary of results
mean difference (SMD) was calculated for continuous                      Overall assessment of the quality/certainty of
measures. The resulting overall effect was considered             evidence was independently performed using the
small, moderate or large according to Cohen's d                   GRADE approach [53] applied to the results of the
thresholds of 0.2, 0.5 and 0.8 [44]. The 95%                      meta-analysis. Disagreements that arose were resolved
confidence interval was considered to represent the               by comparison and discussion.
deviation from the point estimate for each individual
study and from the global estimated value for the
                                                                  RESULTS
aggregated studies. The presence of heterogeneity (p
< 0.05) among studies was assessed with the Cochran               Selection of studies
Q test [45] and the degree of heterogeneity was                            The electronic database search returned 50
quantified with the Higgins I2 index [46]. Values of I2           records. Figure 1 shows the selection process.
≤ 30%, 30-60%, 60-90% or > 90% were assigned a                    Bibliographies of eligible studies and journal searches
low, moderate, high or very high level of                         yielded no other relevant studies. The corresponding
heterogeneity [47].                                               authors of the included studies were contacted by e-
                                                                  mail; none were aware of additional studies of
Sensitivity analysis                                              interest.
        In case of at least one outlier study, a                           Ultimately, three studies met the inclusion
sensitivity analysis was performed by regenerating a              criteria. A summary of their main characteristics is
meta-analysis after its exclusion.                                shown in Table 2.

Additional analyses
         If possible, analyses were planned to assess
the effectiveness of the intervention according to
gender, age, severity of cerebral palsy, and level of
intellectual disability of participants.



      Corresponding author:                                  47                                 Submission received: 21/09/2022
      Luca Giuseppe Re - luca.re@unimi.it                                                End of Peer Review process: 21/10/2022
      Padiglione 6, ala C, Piano 1°                                                                       Accepted: 11/11/2022
      Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                      This work is licensed under a Creative Commons
       Dissertation Nursing V.2, N.1 (30/01/2023)                     Attribution-NonCommercial-NoDerivatives 4.0 nternational
                                                                                                                                     DOI: 10.54103/dn/18716




                     DISSERTATION NURSING
                     Journal Homepage: https://riviste.unimi.it/index.php/dissertationnursing




                                    Identification of studies via databases and registers                           Identification of studies via other methods



                        Records identified from:                            Records removed before
Identification




                            Cochrane Library, MEDLINE,                      screening:
                            CINAHL, EMBASE, PsycINFO,                            Duplicate records                Records identified from:
                            Web of Science, Scopus, LILACS,                      removed (n = 13)                    BASE, TRIP Medical Database (n = 30)
                            sciELO, CNKI) (n = 18); ICTRP,                       Records removed                     Citation searching (n = 0)
                            ClinicalTrials.gov, EU Clinical Trials               for other reasons (n
                            Register, ISRCTN registry (n = 2)                    = 4)




                        Records screened                                    Records excluded
                        (n = 3)                                             (n = 0)




                        Reports sought for retrieval                                                              Reports sought for                    Reports not
                                                                             Reports not retrieved                retrieval                             retrieved
Screening




                        (n = 3)                                              (n = 9)                              (n = 0)                               (n = 0)



                                                                                                                  Reports assessed for                  Reports
                        Reports assessed for eligibility                     Reports excluded                     eligibility                           excluded
                        (n = 3)                                              (n = 0)                              (n = 0)                               (n = 0)




                       Studies included in review
   Included




                       (n = 3)
                       Reports of included studies
                       (n = 3)




                                                                        Figure 1: Records screening.




                 Corresponding author:                                               48                                     Submission received: 21/09/2022
                 Luca Giuseppe Re - luca.re@unimi.it                                                                 End of Peer Review process: 21/10/2022
                 Padiglione 6, ala C, Piano 1°                                                                                        Accepted: 11/11/2022
                 Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                                                  This work is licensed under a Creative Commons
                  Dissertation Nursing V.2, N.1 (30/01/2023)                                      Attribution-NonCommercial-NoDerivatives 4.0 nternational
                                                                                                                                                                                                                   DOI: 10.54103/dn/18716




                                                             DISSERTATION NURSING
                                                             Journal Homepage: https://riviste.unimi.it/index.php/dissertationnursing
                 DESIGN, COUNTRY



                                               PROCEDURE
                                    SETTING




                                                                                                                                                                                             PRIMARY
STUDY




                                                                                                 EXCLUSION                                                                                OUTCOME AND                                            ADDITIONAL
                                                                              SAMPLE                                           INTERVENTION                          CONTROL                                             RESULTS
                                                                                                  CRITERIA                                                                                 EVALUATION                                              NOTES
                                                                                                                                                                                            METHOD




                                                                           45 children with        Children with        The children's parents are by their           The children's         Assessment of           Intervention group:         The procedure was
Ben-Pazi, 2017

                 qRCT+cCT, Israel

                                    Clinic

                                               Botulinum toxin injection




                                                                           an age range of          very limited          side throughout the procedure           parents are by their      procedural pain                 n=20                  performed under
                                                                            1.5 to 18 years       communication          A gender not declared clown with         side throughout the       before and after         VAS after procedure         electromyographic
                                                                            Mean age 7.04          skills, autism         certified experience and formal               procedure         sessions (VAS with           Mean value 2.89                guidance
                                                                                 years               spectrum         training course interacts with the child        Following the          5-faces scale)        Standard Deviation 1.36
                                                                               67% male          disorders, severe          before, during, and after the            procedure, the          Parents report            Control group:
                                                                            Percentage of        anxiety requiring    procedure with distraction techniques          treatment staff      personal perception               n=25
                                                                           children at first          general            based on the child's age, cognitive       interacts positively   of pain experienced        VAS after procedure
                                                                           injection: 100%           anesthesia           level, and personal preferences          with the child and      by the child if the        Mean Value 3.85
                                                                           All with cerebral                             Following the procedure, the care        offers rewards in an     child is unable to      Standard Deviation 1.39
                                                                             palsy (mean                              staff interacts positively with the child     effort to reshape      report it (children          P value: 0.036
                                                                            GMFCS level:                                 and offers rewards in an effort to        negative memories        younger than 5
                                                                                  III)                                 reshape negative memories toward a           toward a positive     years, children with
                                                                                                                                  positive direction                     direction             significant
                                                                                                                                                                                               intellectual
                                                                                                                                                                                                disability)

                                                                           60 children with       Children with         Children during the procedure are           Parents and care         Assessment of                Females                 86% of children
Hansen, 2011

                 qRCT, Denmark

                                    Clinic

                                               Botulinum toxin injection




                                                                           an age range of 1        impaired             supported by their mother and             team interact with        procedural pain        Intervention group:          received sedation
                                                                               to 15 years       sensitivity (e.g.,       sometimes their father as well            the child before,         after the first           23 sessions               with Midazolam
                                                                           Mean age 4 years       subjects with       The doctor, nurse, physical therapist       during, and after the     botulinum toxin      Mean duration of crying: 62
                                                                                57% male          spina bifida)            and clown are also present                  procedure           injection: duration            seconds
                                                                              Percentage of                            The female clown interacts with the                                of crying in seconds         Control group:
                                                                            children at first                              child 15 minutes before the                                                                  25 sessions
                                                                             injection: 53%                           procedure, during the procedure, and                                                       Mean duration of crying: 132
                                                                                Most with                              also several minutes after it is over                                                                 sec
                                                                              cerebral palsy                             The clown decides based on the                                                                P value: 0.049
                                                                            (mean GMFCS                               child's emotional state the best ways
                                                                           level: not stated)                                to interact with the child                                                                      Males
                                                                                                                                                                                                                     Intervention group:
                                                                                                                                                                                                                          30 sessions
                                                                                                                                                                                                                 Mean duration of crying: 160
                                                                                                                                                                                                                               sec
                                                                                                                                                                                                                        Control group:
                                                                                                                                                                                                                          43 sessions
                                                                                                                                                                                                                 Mean duration of crying: 86
                                                                                                                                                                                                                            seconds
                                                                                                                                                                                                                        P value: 0.139
                                                                           59 children with         Not stated        One to three male or female clowns           Children may listen      Assessment of            Intervention group:
                                                                                                                                                                                                                             The procedure was
                 nRCT, France
Houx, 2019



                                    Clinic

                                               Botulinum toxin injection




                                                                           an age range of 0                                      may be present                  to music, watch TV,       procedural pain               40 sessions
                                                                                                                                                                                                                              performed under
                                                                               to 15 years                               They use different strategies to         play video games, or     after the session     FLACC after the procedure
                                                                                                                                                                                                                             electromyographic
                                                                              Median age: 4                               interact and distract the child,           discuss topics of    (FLACC scale with            Median value: 1.5
                                                                                                                                                                                                                                     and/or
                                                                                   years                              depending on the child's age and the         interest to them or        score 0-10)         Interquartile range: 0.5-3.4
                                                                                                                                                                                                                              ultrasonographic
                                                                                59% male                                number of injections to be given             suggested by the                                   Control group:
                                                                                                                                                                                                                                    guidance
                                                                              Percentage of                           The clown also supports the parents         nurse or a caregiver                                    48 sessions
                                                                                                                                                                                                                             An analgesic cream
                                                                             children at first                         or caregivers and, at the end of the       Before the injection,                          FLACC after the procedure
                                                                                                                                                                                                                              was applied to all
                                                                              injection: not                               procedure, provides positive             the child or parent                                 Median value: 2
                                                                                                                                                                                                                                children on the
                                                                                  stated                              reinforcement to the child for future       or caregiver is asked                               Interquartile range:
                                                                                                                                                                                                                             areas to be pricked
                                                                                88% with                                             sessions                         about particular                                        1-3.2
                                                                                                                                                                                                                             at least 60 minutes
                                                                              cerebral palsy                                                                         interests or what                                  P value: 0.349
                                                                                                                                                                                                                                   before the
                                                                            (GMFCS level I                                                                           would promote a                                               procedure
                                                                                  to III)                                                                          relaxed atmosphere                                          If there were no
                                                                                20% with                                                                                                                                             medical
                                                                              moderate-to-                                                                                                                                    contraindications,
                                                                            severe cognitive                                                                                                                                       N2O was
                                                                                disorders                                                                                                                                       administered 5
                                                                                                                                                                                                                             minutes before the
                                                                                                                                                                                                                                procedure, and
                                                                                                                                                                                                                             unless side effects
                                                                                                                                                                                                                                   occurred,
                                                                                                                                                                                                                                administration
                                                                                                                                                                                                                                   continued
                                                                                                                                                                                                                                throughout the
                                                                                                                                                                                                                                   procedure
                                                                                  cCT=crossover Clinical Trial; GMFCS = Gross Motor Function Classification System; nRCT=non Randomized Controlled Trial; qRCT=quasi Randomized Controlled Trial.



                                                                                                                                Table 2: Characteristics of the studies.

                                         Corresponding author:                                                                                              49                                          Submission received: 21/09/2022
                                         Luca Giuseppe Re - luca.re@unimi.it                                                                                                                     End of Peer Review process: 21/10/2022
                                         Padiglione 6, ala C, Piano 1°                                                                                                                                            Accepted: 11/11/2022
                                         Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                                                                                                                            This work is licensed under a Creative Commons
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          DISSERTATION NURSING
          Journal Homepage: https://riviste.unimi.it/index.php/dissertationnursing



Characteristics of the studies                                    level, emotional state and preferences of the child as
         One study (55) consists of two separate                  well as the duration of the session. In all studies the
studies: a quasi-randomized controlled clinical trial             clown doctor was present on certain days of the week
(qRCT) and a crossover study. One study is a qRCT                 and at set times. In the control group,
(56), another is a non-randomised controlled clinical             parents/caregivers and healthcare staff offered the
trial (nRCT) (57). A total of 164 children (61% male)             child comfort, attention, and positive reinforcement
with age range 0-18 years (mean age: 4-7 years),                  (55,56), or even alternative distraction techniques
almost all with CP, were included. The sample size                (e.g., watching TV, listening to music, playing video
ranged from 45 (55) to 60 (56) individuals. Studies               games) (57). All studies assessed children's procedural
were conducted in Denmark (56), France (57) and                   pain, in one case also children's and parent's anxiety
Israel (55), all in hospital outpatient clinics. The              (57). The authors of one study (55) had the child
common procedure was intramuscular injection of                   assess pain with the 5-sided Visual Analogue Scale
botulinum toxin (BTI); each session participants                  (VAS) immediately before and after the procedure; in
underwent could include one or more injections. In                the presence of children younger than 5 years or with
one study (55), children attended the session for the             significant intellectual disability it was the parents,
first time and were given clown therapy or standard               using the same instrument, who assessed pain. In one
of care; then, several months later, subjects were                study, pain assessment was performed by measuring
given another session and those who had received the              the duration of crying in seconds after the first
intervention in the first session were given standard             injection (56). The authors presented results separated
of care (and vice versa). When stated, children with              by gender. In the most recent study (57), pain was
severe limitations in communication skills (e.g.,                 measured during the session using the FLACC scale
individuals with severe mental retardation) (55) or               (58), with a second pain assessment made at the end
sensory impairments (e.g., individuals with spina                 of the session using a 100 mm VAS scale by children
bifida) were excluded from the trial (56). One study              over 5 years old who were able to communicate and
(55) did not report the use of sedatives or analgesics            by parents. The level of anxiety was also measured
prior to the session, while in one study (56) most                with a 100 mm VAS scale before, during and 10
children (86%) had been given midazolam and in                    minutes after the session only by children over 5 years
another had been given inhaled nitrous oxide (N2 O)               old who were able to communicate and their parents.
and analgesic cream had been applied to the areas                 The authors presented the results of the effect of the
where the injections were to be performed (57). In                intervention on pain also as a function of some
both cases preventive treatment was delivered to both             variables such as gender, age, presence or absence of
the intervention and control groups. In addition, in              cognitive impairment. Satisfaction with the
the intervention group there was the presence of at               intervention as perceived by the parent/caregiver and
least one clown doctor who interacted with the child              healthcare staff was investigated in two studies
before (55,56), during and after (55-57) the execution            (55,56).
of the session in the presence of at least one
parent/caregiver; the distraction techniques applied
by the clown changed according to the age, cognitive

      Corresponding author:                                  50                                 Submission received: 21/09/2022
      Luca Giuseppe Re - luca.re@unimi.it                                                End of Peer Review process: 21/10/2022
      Padiglione 6, ala C, Piano 1°                                                                       Accepted: 11/11/2022
      Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
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          Journal Homepage: https://riviste.unimi.it/index.php/dissertationnursing



Risk of study bias                                                                some concern [55]. Overall, the risk of bias is high for
         The risk of bias assessment of the included                              two studies [54, 56] and a source of some concern for
studies is summarized in Figure 2 and Figure 3. The                               one [55].
studies raise some concerns about the randomization                                       One study (55) stated for one of the authors a
process and deviations from the intended                                          possible conflict of interest and that he had received
interventions; the risk of bias due to lack of outcome                            partial financial support from a private foundation;
data is low, as well as for that related to the selection                         the authors of another (56) stated that the clown's
of report outcomes. Two studies are at high risk of                               services had been paid for with donations from
bias in outcome measurement [54, 56] and one is of                                private organizations.




                                                                                         Low Risk           Some Concerns          High Risk


                                                        Figure 2: risk of bias assessment (part 1).




                                                        Figure 3: risk of bias assessment (part 2).




      Corresponding author:                                                 51                                   Submission received: 21/09/2022
      Luca Giuseppe Re - luca.re@unimi.it                                                                 End of Peer Review process: 21/10/2022
      Padiglione 6, ala C, Piano 1°                                                                                        Accepted: 11/11/2022
      Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                                       This work is licensed under a Creative Commons
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          DISSERTATION NURSING
          Journal Homepage: https://riviste.unimi.it/index.php/dissertationnursing



DATA ANALYSIS                                                                   control group were: number of sessions, mean value
                                                                                and exact p-value. Overall, the effect of clown
Procedural pain
                                                                                therapy for procedural pain in children with CP was
        The least recent study (56) presented results
                                                                                assessed for 332 sessions. The aggregate SMD is -0.20
divided by participant sex and provided only the
                                                                                (95% CI: -0.56, 0.17) in favor of clown therapy; the
mean value. The most recent study (57) presented
                                                                                result is not statistically significant (Table 3). Q-test
results using the median and interquartile range; with
                                                                                shows statistically significant (p = 0.045) and high
the application of a conversion technique the median
                                                                                grade heterogeneity (I2 = 62.78%).
was transformed to the mean (59,60) to allow
comparison with other studies. Finally, the results of
                                                                                Child and Parent Anxiety
one study were presented with the mean and standard                                      One study (57) evaluated the effect of clown
deviation (55). However, unlike the previous two                                therapy for child-perceived anxiety during and after
studies, in this one the unit of analysis was the child                         the procedure. The authors did not observe a
and not the session. To use the session as the                                  statistically significant difference between intervention
common unit of analysis and trace it back to the                                and control group. The same study evaluated the
session, the supplementary file available online was                            effect of clown therapy for parent-perceived anxiety,
analysed. Data useful for the meta-analysis and                                 again during and after the procedure; similarly, no
available across studies for the intervention and                               statistically significant difference was observed.




                           Table 3: Procedural pain in children with cerebral palsy - clowning vs. standard of care.

Sensitivity analysis
Given the presence of an outlier study, a sensitivity                           In this way the aggregate SMD is -0.36 (95% CI: -
analysis was performed by performing a meta-analysis                            0.61, -0.11) in favour of clown therapy; the result is
after removing it.                                                              statistically significant (Table 4).




                                               Table 4: Sensitivity analysis – removal of outlier study.


      Corresponding author:                                               52                                   Submission received: 21/09/2022
      Luca Giuseppe Re - luca.re@unimi.it                                                               End of Peer Review process: 21/10/2022
      Padiglione 6, ala C, Piano 1°                                                                                      Accepted: 11/11/2022
      Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                                     This work is licensed under a Creative Commons
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                 Journal Homepage: https://riviste.unimi.it/index.php/dissertationnursing



Additional analysis                                                                                              participants with quadriplegia, in another (57) no
        Sex: Two studies (56,57) presented results as a                                                         difference was found between children who could or
function of participant sex but a quantitative synthesis                                                        could not walk. For both studies the results were not
could not be performed because one (57) did not                                                                 statistically significant.
make explicit, for the same sex, the number of                                                                           Level of cognitive impairment: One study (57)
sessions in which clown therapy or the standard of                                                              assessed the benefit of the intervention according to
care was applied. The corresponding author was                                                                  the presence or absence of cognitive impairment; it
contacted for this information but to no avail. In one                                                          was similar for both types of participants; the result
study (56) clown therapy was effective in reducing the                                                          was not statistically significant.
mean duration of crying in female participants; the                                                             Publication bias
result is statistically significant; in male participants                                                                The funnel plot was not inspected as it was of
the mean duration of crying was longer with clown                                                               little use in the case of a small number of studies. For
therapy; the result is not statistically significant. In the                                                    an objective assessment of the risk of bias, Egger's
other study (57) both sexes benefited from the                                                                  test (intercept = 0.56, t = 0.09, p = 0.935) and Begg
intervention, females to a greater extent than males;                                                           and Mazumdar's test (Kendall's tau = 0.00, p = 1)
the results are not statistically significant.                                                                  were used. The result of both tests, statistically not
        Age: One study (57) found a greater effect of                                                           significant, suggests a minimal impact of publication
the intervention for children at least 9 years old; the                                                         bias.
result was not statistically significant.                                                                       Summary of results
        Severity of cerebral palsy: One study (56)                                                                       The quality of evidence assessed with the
observed a wider benefit of clown therapy in                                                                    GRADE instrument was very low. The summary of
                                                                                                                results is shown in Table 5.
Effectiveness of clown therapy on procedural pain in children with cerebral palsy.
Clown therapy compared to control for procedural pain and anxiety in children, anxiety in parents
Patient or population: children with cerebral palsy undergoing potentially algogenic diagnostic or therapeutic procedures
Setting: any
Intervention: clown therapy
Comparison: standard of care
Outcome             Anticipated absolute effects* (95% CI)                                      N° of sessions Certainty of the                                        Comments**
                    Risk with           Risk with clown therapy                                 (studies)         evidence (GRADE)
                    standard of
                    care
Children            -                   The mean level of procedural pain with clown            332 (2 qRCTs, ⊕⊝⊝⊝                                                     This result equates to a moderate
procedural pain                         therapy was 0.36 standard deviation lower (0.58 to      1 nRCT)           Very lowa,b,c                                        difference in favor of clown
                                        0.14 lower).                                                                                                                   therapy.
Children anxiety -                      -                                                       47 (1 nRCT)       -                                                    This outcome was assessed in one
                                                                                                                                                                       study only.
Parents anxiety         -                      -                                                                  85 (1 nRCT)            -                             This outcome was assessed in one
                                                                                                                                                                       study only.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
**0.2 represents a small difference, 0.5 a moderate difference and 0.8 a large difference.
CI: confidence interval; SMD: standardized mean difference; qRCT: quasi randomized controlled trial; nRCT: non randomized controlled trial
GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
a Downgraded once for serious study limitations: trials had some concerns/high risk of bias.
b Downgraded once for suspicion of publication bias.
c Downgraded once for imprecision: analysis based on < 200 participants per group.




                                                                                 Table 5: Summary of Findings.

           Corresponding author:                                                                       53                                            Submission received: 21/09/2022
           Luca Giuseppe Re - luca.re@unimi.it                                                                                                End of Peer Review process: 21/10/2022
           Padiglione 6, ala C, Piano 1°                                                                                                                       Accepted: 11/11/2022
           Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                                                                        This work is licensed under a Creative Commons
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          DISSERTATION NURSING
          Journal Homepage: https://riviste.unimi.it/index.php/dissertationnursing



DISCUSSION                                                        power and high heterogeneity among studies. Several
        Our study aimed to measure the effectiveness              critical points represent sources of heterogeneity: (a)
of clown therapy compared with usual care on the                  the age range (0-18 years) of participants covers the
procedural pain of children with CP. The included                 entire pediatric range; (b) not all individuals had CP;
studies all focused on pain from intramuscular                    (c) the degree of severity of CP nor the level of
injection of botulinum toxin. This treatment is among             cognitive impairment was not always reported; (d) not
those planned for children with CP and is the most                all children were at their first experience of botulinum
widely used, effective, and safe method of reducing               toxin injection; (e) studies do not make explicit
pain, spasticity, deformity, and improving mobility               whether children had previous experience of other
(14,21,61-63). It usually involves one or more                    needle procedures; (f) the number of injections per
injections into the target muscles (64); the therapeutic          session was variable depending on the participant's
effect lasts 3-6 months, after which the injections               disease characteristics. The session could (56,57) or
need to be replicated (64,65). Although the procedure             could not (55) be preceded by the administration of
is short-lived, pain may occur during electrical muscle           sedative or analgesic agents. Clown therapy was
stimulation, puncture, and botulinum toxin                        performed by one (55,56) up to three (57) clown
inoculation (66). Judicious selection of sedative and             doctors, of undisclosed gender (except in one study
analgesic agents and implementation of specific                   (56) where it was specified to be a woman). Expertise
intramuscular      injection    guidance      techniques          and experience in the field was not described except
(ultrasound, electrical stimulation, electromyography)            generically, as were the distraction techniques applied.
are essential to reduce procedural pain and related               The standard of care could consist of comfort,
anxiety in children with cerebral palsy (67,68).                  attention and positive reinforcement from parents
However, the use of preventive treatments such as                 and/or care staff or include the provision of
nitrous oxide and anaesthetic cream seems effective               alternative distraction techniques. The instruments
for only half of children (66); hence the need for the            used for pediatric pain assessment were
contribution of non-pharmacological interventions,                heterogeneous        and       sometimes      improperly
including distraction techniques such as clown                    implemented. Specifically:           1) pediatric pain
therapy or play therapy (61,67,69-71). In children with           assessment scales are not effectively validated for
CP, clown therapy appears to have good potential to               children with intellectual disability, who make up a
help reduce procedural pain from intramuscular                    large proportion of those with cerebral palsy, or for
injection of botulinum toxin. The review highlighted              children undergoing sedation, as was the case for
that the intervention has an effect, albeit small (SMD            most of the subjects analyzed by one study [55]; 2)
= -0.2), on the symptom; on the other hand, given                 one study used the FLACC scale on a sample of
the rather low quality of the evidence, it is possible            children from 0 to 15 years of age [56], but this
that the actual effect is very different from that                instrument is validated for younger children, from 2
estimated. The results should be viewed with great                months to 7 years of age; 3) in two studies, the pain
caution because of the few studies with low numbers               perceived by children during the procedure is also
of participants (n = 164) and important                           assessed according to the parent's perception [54, 56],
methodological limitations resulting in low statistical           and in one, pain is measured indirectly by quantifying

      Corresponding author:                                  54                                 Submission received: 21/09/2022
      Luca Giuseppe Re - luca.re@unimi.it                                                End of Peer Review process: 21/10/2022
      Padiglione 6, ala C, Piano 1°                                                                       Accepted: 11/11/2022
      Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                      This work is licensed under a Creative Commons
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          DISSERTATION NURSING
          Journal Homepage: https://riviste.unimi.it/index.php/dissertationnursing



the duration of crying of young patients after the first          algogenic procedures these children undergo, such as
injection [55]. There is no doubt that the child's ability        physiotherapy, or corrective treatments such as
to comply with potentially painful repeated clinical              orthotics or orthopaedic surgery. Due to the nature of
procedures depends on gender, age, temperament,                   the intervention, it was not possible to achieve
previous adverse experiences, and coping style (72).              blindness of the participants and health workers;
These variables may act as moderators of the effect of            however, there would be ways to blind the assessor,
clown therapy; the same can be said of the child's                for example by filming the procedure and hiding the
personal sense of humor, which involves affective,                presence of the clown doctor (78). Clown therapy
social and cognitive processes and whose complexity               appears more effective in the female sex. Sensitivity
may act as a barrier against the methodological rigor             analysis would seem to confirm this hypothesis, as by
of studies (73). The results obtained from our study              removing the outlier study, involving only male
are consistent with those of previous systematic                  participants, the effect size increases and becomes
reviews that have evaluated the effect of clown                   statistically significant. However, this fluctuation in
therapy in children without CP (37-42): the                       results with few studies with small samples could be
intervention may be useful in reducing procedural                 the result of chance; the hypothesis that sex acts as a
pain. Furthermore, as evidenced by a pilot study (74)             moderator of the intervention effect would therefore
aimed at understanding the effects of clown therapy               need to be confirmed by further research. The effect
on children with physical, cognitive or developmental             of the intervention seems to be age-dependent, but
disabilities and undergoing long-term rehabilitation              perhaps it would be more important to know for
therapy, the intervention manifests an overall positive           which age group clown therapy reaches its maximum
effect on their mood and well-being even with severe              effectiveness. It would also be important to know if
disabilities. Parents, caregivers, physicians and nurses          the benefit changes according to the level of cognitive
are in favour of the integration of clown therapy in              impairment or to the degree of severity of the disease.
health care settings (55.57,75,76) also because,                  Child and parent anxiety has only been analyzed in
compared to other distraction techniques, the clown               one study (57), which found no statistically significant
can adapt its performance according to the child's                differences between the two groups. However, this
cognitive development within a non-demanding                      result may have been affected by the synergistic effect
approach (72). The intervention also appears to be                of low pre-session anxiety and the prior use of
cost-effective (77). Against these advantages, in the             sedatives and analgesics. It would be important to
included studies the clown was unfortunately only                 conduct further research on the assessment of
available on certain days and times.                              anxiety, as it is closely related to procedural pain and
                                                                  more present in children with intellectual disability
Research implications                                             (29), a condition that severely affects 26.7% of
        In order to achieve greater certainty about the           individuals with CP (79). No study has used
efficacy of the intervention, further studies with larger         coulrophobia (or “fear of clowns”) as an exclusion
samples, higher methodological quality, and low risk              criterion; however, it would be interesting to study its
of bias are needed. These studies should also address             impact in the pediatric population with future
the effect of the intervention on other potentially               research. Another suggestive question concerns the

      Corresponding author:                                  55                                 Submission received: 21/09/2022
      Luca Giuseppe Re - luca.re@unimi.it                                                End of Peer Review process: 21/10/2022
      Padiglione 6, ala C, Piano 1°                                                                       Accepted: 11/11/2022
      Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                      This work is licensed under a Creative Commons
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                                                                                                         DOI: 10.54103/dn/18716




           DISSERTATION NURSING
           Journal Homepage: https://riviste.unimi.it/index.php/dissertationnursing



effect a pediatric physician or pediatric nurse might             physiotherapy, orthotics, or orthopedic surgery, or
have compared to that of a clown doctor if they wore              that compare it with other distraction techniques (e.g.,
a clown costume and had a joking and funny manner.                iPads, use of virtual reality).

Limits                                                            REFERENCES
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      Corresponding author:                                  56                                 Submission received: 21/09/2022
      Luca Giuseppe Re - luca.re@unimi.it                                                End of Peer Review process: 21/10/2022
      Padiglione 6, ala C, Piano 1°                                                                       Accepted: 11/11/2022
      Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                                      This work is licensed under a Creative Commons
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  Luca Giuseppe Re - luca.re@unimi.it                                            End of Peer Review process: 21/10/2022
  Padiglione 6, ala C, Piano 1°                                                                   Accepted: 11/11/2022
  Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
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  Corresponding author:                                  58                             Submission received: 21/09/2022
  Luca Giuseppe Re - luca.re@unimi.it                                            End of Peer Review process: 21/10/2022
  Padiglione 6, ala C, Piano 1°                                                                   Accepted: 11/11/2022
  Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
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  Corresponding author:                                  59                             Submission received: 21/09/2022
  Luca Giuseppe Re - luca.re@unimi.it                                            End of Peer Review process: 21/10/2022
  Padiglione 6, ala C, Piano 1°                                                                   Accepted: 11/11/2022
  Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
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  Luca Giuseppe Re - luca.re@unimi.it                                            End of Peer Review process: 21/10/2022
  Padiglione 6, ala C, Piano 1°                                                                   Accepted: 11/11/2022
  Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
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  Corresponding author:                                  61                             Submission received: 21/09/2022
  Luca Giuseppe Re - luca.re@unimi.it                                            End of Peer Review process: 21/10/2022
  Padiglione 6, ala C, Piano 1°                                                                   Accepted: 11/11/2022
  Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
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  Corresponding author:                                  62                             Submission received: 21/09/2022
  Luca Giuseppe Re - luca.re@unimi.it                                            End of Peer Review process: 21/10/2022
  Padiglione 6, ala C, Piano 1°                                                                   Accepted: 11/11/2022
  Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy
                                                              This work is licensed under a Creative Commons
   Dissertation Nursing V.2, N.1 (30/01/2023)                 Attribution-NonCommercial-NoDerivatives 4.0 nternational
