The Benefit of the Intervention of Clowns in Pediatric Oncology in the Accompaniment of Painful Acts

Study Overview
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Brief Summary
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The diagnosis and treatment of childhood cancer involves frequent and repeated painful acts. The pediatric oncology-hematology service of Nancy's hospital innovates thanks to the involvement of clowns in the hospital. The effects of the clown's intervention corroborate the results of studies which demonstrate that when painful complaints are increased by an empathetic attitude, they are reduced by half when the child is distracted. The main objective is to assess the impact of the presence or absence of clowns during the performance of a painful act, on pain, in children who have benefited from this act. no clowns during the performance of a painful act, on anxiety, in children who have benefited from this act. The secondary objectives are: Evaluate the impact of the presence or not of clowns during the performance of a painful act, on the anxiety of the parents of the child who benefited from this act. Measure the perception and acceptance of the healthcare team of the presence of clowns 1 time every 3 months. Measure the clowns' perception of their interaction with the child, the parents and the healthcare team once every 3 months. Evaluate the overall impact of the clown intervention during the performance of a painful act in children on the course of the act by a neutral person (health manager) once every 3 months.

Official Title
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Study on the Benefit of the Intervention of Clowns in Pediatric Oncology in the Accompaniment of Painful Acts

Conditions
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Pain

Intervention / Treatment
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* Other: clowns


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child virgin with experience for targeted acts during the 1st painful act or child undergoing follow-up provided that he is virgin with experience of the presence of clowns during these acts. Child with cancer Child requiring a painful act among the following 3 acts: lumbar puncture, myelogram, needle placement in an implantable chamber Parental authority holder (s) who have received full information on the organization of the research and who have given their written consent for the participation of their child Personal adhesion of the child with a view to his participation Presence of at least one of the two parents during act 1 Availability of the duo of clowns for the realization of act n ° 1 if the group assigned is the group Clowns-Sans Clowns Exclusion Criteria: Parents / child's refusal of clowns to intervene

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Without Clowns - Clowns (WC-C)<br>Firstly a painful act without the presence of the clown duo, then in a second time the same painful act in the presence of the clown duo | Other: clowns<br>* presence or absence of clowns during the performance of a painful act, on pain<br>|
| Other: Clowns- Without clowns (C-WC)<br>Firstly a painful act with the presence of the clown duo, then in a seconde time, the same painful act without the presence of the clown duo | Other: clowns<br>* presence or absence of clowns during the performance of a painful act, on pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pain score of the patient Self Assessment Scale (VAS) | The scale is between 0 to 100 | inclusion, up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS) | The scale is between 0 to 100 If the score is inferior to 24, the patient is considered relaxed If the score is superior to 24, the patient is considered anxious | inclusion, up to 2 years | 
| Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS) | The scale is between 0 to 100 If the score is inferior to 24, the patient is considered relaxed If the score is superior to 24, the patient is considered anxious | up to 8 weeks after inclusion | 
| Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B) | The score is between 21 to 77 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety | inclusion, up to 2 years | 
| Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B) | The score is between 21 to 77 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety | up to 8 weeks after inclusion | 
| Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A) | The score is between 20 to 80 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety | inclusion, up to 2 years | 
| Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A) | The score is between 20 to 80 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety | up to 8 weeks after inclusion | 
| Score of perception and acceptance of the presence of clowns with the healthcare team Questionnaire | The questionnaire is composed by 19 questions The scale of each question is between 1 (not agree at all) to 4 (totally agree) | through completion of the study, an average of 2 years | 
| Perception score of interactions with the child, parents and the team with clowns Questionnaire | The questionnaire is composed by 12 questions The scale of each question is between 1 (not agree at all) to 4 (totally agree) | through completion of the study, an average of 2 years | 
| Score of evaluation of the overall impact of the presence or not of a clown Questionnaire | The observation gris is composed by 14 questions | through completion of the study, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain