AnxietyCOLORINCT03489980
Influence of the Coloring of a Complex Form on Anxiety Associated With Care.
An observational study of Anxiety, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- coloring-type artistic task of a complex form
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2018to 3 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient from Sainte-Musse Hospital
Who may be able to join
- 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:
Show all 15Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon, 83200
About this study
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.
- Conditions
- Anxiety
- Being tested
- coloring-type artistic task of a complex form
- Keywords
- STAI Questionnaire, ECTM2-Qa
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coloring-type artistic task of a complex formOther
coloring-type artistic task of a complex form
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: coloring-type artistic task of a complex form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety state
Self questionnaire STAI-YA before and after coloring
Measured: 20 minutes
Secondary outcomes (2)
Anxiety trait
Self questionnaire STAI-YB
Measured: 0 minutes
Experience of activity
Self questionnaire ECTM-Q2a after coloring
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start11 Apr 2018
- Primary completion3 Jul 2018
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick Knefati, MD, Study director, Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489980
- Sponsor's protocol ID
- 2017-CHITS-06
- Other IDs
- 2017-A03537- 49
- Acronym
- COLORI
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2018
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Coloring of a Complex Form on Anxiety Associated With Care.
- ClinicalTrials.gov ID
- NCT03489980
- Acronym / sponsor ID
- COLORI / 2017-CHITS-06
- Conditions
- Anxiety
- Keywords
- STAI Questionnaire, ECTM2-Qa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ambulatory consultation waiting room | – | Other: coloring-type artistic task of a complex formPatient from ambulatory consultation waiting room Group, coloring-type artistic task of a complex form before a medial consultation with hospital practitioner. |
| Hemodialysis service | – | Other: coloring-type artistic task of a complex formPatient from ambulatory consultation waiting room Group, coloring-type artistic task of a complex form during hemodialysis. |
| Day hospitalization service : psychiatry | – | Other: coloring-type artistic task of a complex formPatient from ambulatory consultation waiting room Group, coloring-type artistic task of a complex form during day hospitalization. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient from Sainte-Musse Hospital
Key inclusion criteria (15 listed)
- 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).
- Men or women over the age of 18 and under the age of 65.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coloring-type artistic task of a complex formcoloring-type artistic task of a complex form | Other | Ambulatory consultation waiting room, Day hospitalization service : psychiatry, Hemodialysis service |
Primary outcome
Change in anxiety state
Time frame: 20 minutes
Self questionnaire STAI-YA before and after coloring
2 secondary outcomes
Anxiety trait
Time frame: 0 minutes
Experience of activity
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Results publication: PubMed 38449752Dias 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannick Knefati, MD study director
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety state (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03489980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.