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

Central Hospital, Nancy, France1 site in 1 country74 target enrollmentFebruary 8, 2022

ConditionsPain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pain
Sponsor: Central Hospital, Nancy, France
Enrollment: 74
Locations: 1
Primary Endpoint: Change of Pain score of the patient Self Assessment Scale (VAS)
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 8, 2022

End Date

October 8, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Central Hospital, Nancy, France

Responsible Party

Principal Investigator

Madame Valérie GAÜZES

Principal Investigator

Central Hospital, Nancy, France

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: inclusion, up to 2 years

The scale is between 0 to 100

Secondary Outcomes

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)(up to 8 weeks after inclusion)
Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A)(up to 8 weeks after inclusion)
Score of perception and acceptance of the presence of clowns with the healthcare team Questionnaire(through completion of the study, an average of 2 years)
Perception score of interactions with the child, parents and the team with clowns Questionnaire(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(through completion of the study, an average of 2 years)