NCT03489980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

April 11, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2018

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 20, 2018

Last Update Submit

March 29, 2024

Conditions

Anxiety

Keywords

STAI QuestionnaireECTM2-Qa

Outcome Measures

Primary Outcomes (1)

  • Change in anxiety state

    Self questionnaire STAI-YA before and after coloring

    20 minutes

Secondary Outcomes (2)

  • Anxiety trait

    0 minutes

  • Experience of activity

    10 minutes

Study Arms (3)

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

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

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

Interventions

coloring-type artistic task of a complex formOTHER

coloring-type artistic task of a complex form

Ambulatory consultation waiting roomDay hospitalization service : psychiatryHemodialysis service

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient from Sainte-Musse Hospital

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier intercommunal de Toulon La Seyne sur Mer

Toulon, 83200, France

Location

Related 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. eCollection 2024.

    PMID: 38449752RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Yannick Knefati, MD

    Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

April 6, 2018

Study Start

April 11, 2018

Primary Completion

July 3, 2018

Study Completion

July 3, 2018

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)