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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03489980
Other study ID # 2017-CHITS-06
Secondary ID 2017-A03537- 49
Status Completed
Phase
First received
Last updated
Start date April 11, 2018
Est. completion date July 3, 2018

Study information

Verified date March 2024
Source Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date July 3, 2018
Est. primary completion date July 3, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
coloring-type artistic task of a complex form
coloring-type artistic task of a complex form

Locations

Country Name City State
France Centre hospitalier intercommunal de Toulon La Seyne sur Mer Toulon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

References & Publications (1)

Dias Alves M, Olmi E, Durand JY, Mitri F, Knefati Y, Vion-Dury J. Coloring complex shapes decreases patient anxiety in three care environments: a pilot study with color analysis. Front Psychol. 2024 Feb 21;15:1336202. doi: 10.3389/fpsyg.2024.1336202. eCol — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in anxiety state Self questionnaire STAI-YA before and after coloring 20 minutes
Secondary Anxiety trait Self questionnaire STAI-YB 0 minutes
Secondary Experience of activity Self questionnaire ECTM-Q2a after coloring 10 minutes
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