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

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Pain

Treatments: Other: clowns

Study type: Interventional

Funder types: Other

Identifiers

NCT05206344

2019-A03302-55

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

74 participants in 2 patient groups

Without Clowns - Clowns (WC-C)

Other group

Description:

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

Treatment:

Other: clowns

Clowns- Without clowns (C-WC)

Other group

Description:

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

Treatment:

Other: clowns