COLORI: Influence of the Coloring of a Complex Form on Anxiety Associated With Care.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Other)

Overall Status

Completed

CT.gov ID

NCT03489980

Collaborator

(none)

Enrollment

Location

2.7

Actual Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the contribution of a coloring-type artistic task of a complex form in the reduction of anxiety related to care and pathology by a self-questionnaire "State-Trait anxiety inventory" and a self-questionnaire on the experience of the activity, in 3 different medical situations: in day hospitalization service in psychiatry, in hemodialysis service and in an ambulatory consultation waiting room.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Other: coloring-type artistic task of a complex form

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

31 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Influence of the Coloring of a Complex Form on Anxiety Associated With Care.

Actual Study Start Date :

Apr 11, 2018

Actual Primary Completion Date :

Jul 3, 2018

Actual Study Completion Date :

Jul 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
Ambulatory consultation waiting room Patient from ambulatory consultation waiting room Group, coloring-type artistic task of a complex form before a medial consultation with hospital practitioner.	Other: coloring-type artistic task of a complex form coloring-type artistic task of a complex form
Hemodialysis service Patient from ambulatory consultation waiting room Group, coloring-type artistic task of a complex form during hemodialysis.	Other: coloring-type artistic task of a complex form coloring-type artistic task of a complex form
Day hospitalization service : psychiatry Patient from ambulatory consultation waiting room Group, coloring-type artistic task of a complex form during day hospitalization.	Other: coloring-type artistic task of a complex form coloring-type artistic task of a complex form

Arm

Intervention/Treatment

Ambulatory consultation waiting room

Patient from ambulatory consultation waiting room Group, coloring-type artistic task of a complex form before a medial consultation with hospital practitioner.

Other: coloring-type artistic task of a complex form

coloring-type artistic task of a complex form

Hemodialysis service

Patient from ambulatory consultation waiting room Group, coloring-type artistic task of a complex form during hemodialysis.

Other: coloring-type artistic task of a complex form

coloring-type artistic task of a complex form

Day hospitalization service : psychiatry

Patient from ambulatory consultation waiting room Group, coloring-type artistic task of a complex form during day hospitalization.

Other: coloring-type artistic task of a complex form

coloring-type artistic task of a complex form

Outcome Measures

Primary Outcome Measures

Change in anxiety state [20 minutes]
Self questionnaire STAI-YA before and after coloring

Secondary Outcome Measures

Anxiety trait [0 minutes]
Self questionnaire STAI-YB
Experience of activity [10 minutes]
Self questionnaire ECTM-Q2a after coloring

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Psychiatric Day Hospital Group:

Men or women over the age of 18 and under the age of 65.
Admitted to psychiatric day hospital for at least 10 consecutive days of care.
Person able to perform a coloring and answer a questionnaire, without severe deterioration of the general condition according to the assessment of the investigator.
Patient with stabilized schizophrenia (F20.0).

Hemodialysis Service Group:

Men or women over the age of 18 and under the age of 65.
Person able to perform a coloring and answer a questionnaire, without severe deterioration of the general condition according to the assessment of the investigator.
Person having had at least 6 hemodialysis sessions.
Valid dominant arm (allowing coloring - no fistula).
Person currently on dialysis treatment.

Group Ambulatory consultation waiting room:

Men or women over the age of 18 and under the age of 65.
Person able to perform a coloring and answer a questionnaire, without severe deterioration of the general condition according to the assessment of the investigator.
Consultant a practitioner at the hospital.

Exclusion Criteria:

Person with advanced cognitive impairment that alters the questionnaire response or coloring as assessed by the investigator.
Opposition of the volunteer.
No affiliation to a social security scheme (beneficiary or beneficiary).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier intercommunal de Toulon La Seyne sur Mer	Toulon		France	83200

Sponsors and Collaborators

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

Study Director: Yannick Knefati, MD, Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

ClinicalTrials.gov Identifier:

NCT03489980

Other Study ID Numbers:

2017-CHITS-06
2017-A03537- 49

First Posted:

Apr 6, 2018

Last Update Posted:

Feb 1, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

STAI Questionnaire

ECTM2-Qa

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Feb 1, 2022