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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2024-10-08

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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

clowns

Intervention Type OTHER

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

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

Group Type OTHER

clowns

Intervention Type OTHER

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

Interventions

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clowns

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

Intervention Type OTHER

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