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

NCT05206344 | Unknown DMC

• 1 other identifier: 2019-A03302-55
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• Change of Pain score of the patient Self Assessment Scale (VAS)

  The scale is between 0 to 100

  inclusion, up to 2 years

Secondary Outcomes (9)

• Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS)

  inclusion, up to 2 years

• Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS)

  up to 8 weeks after inclusion

• Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B)

  inclusion, up to 2 years

• Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B)

  up to 8 weeks after inclusion

• Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A)

  inclusion, up to 2 years

Study Arms (2)

Without Clowns - Clowns (WC-C)

OTHER

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

Clowns- Without clowns (C-WC)

OTHER

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

Interventions

clowns OTHER

presence or absence of clowns during the performance of a painful act, on pain

Clowns- Without clowns (C-WC); Without Clowns - Clowns (WC-C)

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Parents / child's refusal of clowns to intervene

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Nancy, 54035, France

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pascal Chastagner

  CHRU de Nancy

  STUDY DIRECTOR

Central Study Contacts

Valérie GAUZES

CONTACT

0383154066; v.gauzes@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: January 25, 2022
• Study Start: February 8, 2022
• Primary Completion: April 8, 2024
• Study Completion: October 8, 2024
• Last Updated: March 14, 2022

Record last verified: 2022-03

Locations

FR (1)