Clinical trial NCT05206344: The Benefit of the Intervention of Clowns in Pediatric Oncology in the Accompaniment of Painful Acts
Official title: Study on the Benefit of the Intervention of Clowns in Pediatric Oncology in the Accompaniment of Painful Acts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Pain
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 74
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change of Pain score of the patient Self Assessment Scale (VAS)
timeFrame: inclusion, up to 2 years
Secondary outcomes:
measure: Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS)
timeFrame: inclusion, up to 2 years
measure: Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS)
timeFrame: up to 8 weeks after inclusion
measure: Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B)
timeFrame: inclusion, up to 2 years
measure: Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B)
timeFrame: up to 8 weeks after inclusion
measure: Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A)
timeFrame: inclusion, up to 2 years
measure: Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A)
timeFrame: up to 8 weeks after inclusion
measure: Score of perception and acceptance of the presence of clowns with the healthcare team Questionnaire
timeFrame: through completion of the study, an average of 2 years
measure: Perception score of interactions with the child, parents and the team with clowns Questionnaire
timeFrame: through completion of the study, an average of 2 years
measure: Score of evaluation of the overall impact of the presence or not of a clown Questionnaire
timeFrame: through completion of the study, an average of 2 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: CHRU de Nancy
name: Pascal Chastagner
role: STUDY_DIRECTOR
References: