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

Pain Clinical Trial

— ICOD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206344
• Other study ID #: 2019-A03302-55
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: October 8, 2024

Study information

• Verified date: March 2022
• Source: Central Hospital, Nancy, France
• Contact: Valérie GAUZES
• Phone: 0383154066
• Email: v.gauzes[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: October 8, 2024
• Est. primary completion date: April 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Pain score of the patient Self Assessment Scale (VAS)	The scale is between 0 to 100	inclusion, up to 2 years
Secondary	Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS)	The scale is between 0 to 100 If the score is inferior to 24, the patient is considered relaxed If the score is superior to 24, the patient is considered anxious	inclusion, up to 2 years
Secondary	Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS)	The scale is between 0 to 100 If the score is inferior to 24, the patient is considered relaxed If the score is superior to 24, the patient is considered anxious	up to 8 weeks after inclusion
Secondary	Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B)	The score is between 21 to 77 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety	inclusion, up to 2 years
Secondary	Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B)	The score is between 21 to 77 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety	up to 8 weeks after inclusion
Secondary	Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A)	The score is between 20 to 80 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety	inclusion, up to 2 years
Secondary	Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A)	The score is between 20 to 80 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety	up to 8 weeks after inclusion
Secondary	Score of perception and acceptance of the presence of clowns with the healthcare team Questionnaire	The questionnaire is composed by 19 questions The scale of each question is between 1 (not agree at all) to 4 (totally agree)	through completion of the study, an average of 2 years
Secondary	Perception score of interactions with the child, parents and the team with clowns Questionnaire	The questionnaire is composed by 12 questions The scale of each question is between 1 (not agree at all) to 4 (totally agree)	through completion of the study, an average of 2 years
Secondary	Score of evaluation of the overall impact of the presence or not of a clown Questionnaire	The observation gris is composed by 14 questions	through completion of the study, an average of 2 years