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

March 29, 2024 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulon, France, 83200
        • Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patient from Sainte-Musse Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety state
Time Frame: 20 minutes
Self questionnaire STAI-YA before and after coloring
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety trait
Time Frame: 0 minutes
Self questionnaire STAI-YB
0 minutes
Experience of activity
Time Frame: 10 minutes
Self questionnaire ECTM-Q2a after coloring
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2018

Primary Completion (Actual)

July 3, 2018

Study Completion (Actual)

July 3, 2018

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (Actual)

April 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-CHITS-06
  • 2017-A03537- 49 (Other Identifier: IdRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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