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CompletedNCT03489980COLORIUpdated Apr 1, 2024

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

An observational study in Anxiety, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-01.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
31
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anxiety

Browse trials for

Keywords

  • STAI Questionnaire
  • ECTM2-Qa
03

In context

Anxiety Disorders Unverified

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 31 is below the median of 168 across 978 observational studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 78 studies on the registry; 20 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patient from Sainte-Musse Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
31 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Othercoloring-type artistic task of a complex form

    coloring-type artistic task of a complex form

06

What researchers measure

Primary outcomes

  1. Change in anxiety state

    Self questionnaire STAI-YA before and after coloring

    Time frame: 20 minutes

Secondary outcomes

  1. Anxiety trait

    Self questionnaire STAI-YB

    Time frame: 0 minutes

  2. Experience of activity

    Self questionnaire ECTM-Q2a after coloring

    Time frame: 10 minutes

07

Study locations

1 site
  • Centre hospitalier intercommunal de Toulon La Seyne sur Mer
    Toulon, 83200, France
08

References and documents

Publications

  • 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. PubMed 38449752 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Jul 2018, 2 months.

Of 411 non-industry observational studies under Anxiety Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 49. This study's 2 months is below that.

Counting every sponsor, half of 439 studies reached it within 19 months; a quarter within 6 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2018
First posted
Apr 6, 2018
StartActual
Apr 11, 2018
Primary completionActual
Jul 3, 2018
CompletionActual
Jul 3, 2018
Last update
Apr 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03489980
Lead sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Responsible party
Sponsor
First posted
Apr 6, 2018
Start date
Apr 11, 2018
Primary completion
Jul 3, 2018
Completion
Jul 3, 2018
Last update
Apr 1, 2024

Study contacts

Yannick Knefati, MD
study director · Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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