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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Other: clowns

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valérie GAUZES; Phone Number: 0383154066; Email: v.gauzes@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54035
    • Recruiting
    • CHRU de Nancy
    • Contact: Valérie Gaüzes
    • Principal Investigator: Valérie Gaüzes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Without Clowns - Clowns (WC-C); 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; presence or absence of clowns during the performance of a painful act, on pain
OTHER: Clowns- Without clowns (C-WC); 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; presence or absence of clowns during the performance of a painful act, on pain

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Director: Pascal Chastagner, CHRU de Nancy

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2022
• Primary Completion (ANTICIPATED): April 8, 2024
• Study Completion (ANTICIPATED): October 8, 2024

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (ACTUAL): January 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Pain
• Other Study ID Numbers: 2019-A03302-55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No