Clinical trial NCT03489980: Influence of the Coloring of a Complex Form on Anxiety Associated With Care.
Official title: Influence of the Coloring of a Complex Form on Anxiety Associated With Care.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Keywords: STAI Questionnaire
ECTM2-Qa
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient from Sainte-Musse Hospital

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in anxiety state
timeFrame: 20 minutes
Secondary outcomes:
measure: Anxiety trait
timeFrame: 0 minutes
measure: Experience of activity
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Toulon
country: France
facility: Centre hospitalier intercommunal de Toulon La Seyne sur Mer
Study officials:
affiliation: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
name: Yannick Knefati, MD
role: STUDY_DIRECTOR
References:
citation: 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.