- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05654376
Art Therapy to Promote Wellbeing and Self-care in Resident Physicians. (ATMIR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to determine if an art therapy intervention could promote the well-being of resident physicians of an university tertiary hospital, as specialized physicians trainees exposed to the risk of burnout.
Using a cycle of 6 bimonthly sessions of group art therapy, the intervention stimulates the creative activity of the participants through various art materials and techniques. Next, they are invited to share their reflexions about the artworks produced, with the group and in presence of the art therapist.
The study mainly evaluates the work-related stress and the self-care grade of the participants, before the intervention, just after it and after a follow-up period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08025
- Hospital Sant Pau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- belonging to the resident physicians collective of the Santa Creu i Sant Pau Hospital.
Exclusion Criteria:
- being with a diagnostic of major depression
- receiving psychotherapy o similar
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group art therapy
Cycle of 6 2-hours bimonthly group art therapy sessions.
|
Participant's creativity is stimulated by visual arts materials and various art therapy techniques, in relation to 6 topics: self-care, stress management, flourishing caregiving, challenging caregiving, loss and grief, and sense of professional meaning. The strategy consists of stimulating an observant and symbolic gaze, facilitating visual expression, promoting communication about what it has been expressed, and gather learning from the multidimensional impact of the creative art process (sensations, emotions, cognitions and spiritual experiences). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of a change in burnout level
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
Score calculations from the validated Spanish version of the Maslach Burnout Inventory Test (MBI-GS).
Minimum-maximum values of Exhaustion subscale: 0-54, lower scores mean better outcome; Minimum-maximum values of Cynicism subscale: 0-30, lower scores mean better outcome; Minimum-maximum values of Professional efficacy subscale: 0-48, lower scores mean worse outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
|
Assessment of a change in burnout level
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Maslach Burnout Inventory Test (MBI-GS).
Minimum-maximum values of Exhaustion subscale: 0-54, lower scores mean better outcome; Minimum-maximum values of Cynicism subscale: 0-30, lower scores mean better outcome; Minimum-maximum values of Professional efficacy subscale: 0-48, lower scores mean worse outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
|
Assessment of a change in burnout level
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Maslach Burnout Inventory Test (MBI-GS).
Minimum-maximum values of Exhaustion subscale: 0-54, lower scores mean better outcome; Minimum-maximum values of Cynicism subscale: 0-30, lower scores mean better outcome; Minimum-maximum values of Professional efficacy subscale: 0-48, lower scores mean worse outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of a change in work-related stress
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
Score calculations from the validated Spanish version of the Perceived Stress Scale (PFS 14).
Minimum-maximum values: 0-56; lower scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
|
Assessment of a change in work-related stress
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Perceived Stress Scale (PFS 14).
Minimum-maximum values: 0-56; lower scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
|
Assessment of a change in work-related stress
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Perceived Stress Scale (PFS 14).
Minimum-maximum values: 0-56; lower scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
|
Assessment of a change in professional quality of life
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
Score calculations from the validated Spanish version of the Professional Quality of Life Scale.
Minimum-maximum values: 9-45; lower scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
|
Assessment of a change in professional quality of life
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Professional Quality of Life Scale.
Minimum-maximum values: 9-45; lower scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
|
Assessment of a change in professional quality of life
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Professional Quality of Life Scale.
Minimum-maximum values: 9-45; lower scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
|
Assessment of a change in self-care
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
Score calculations from the validated original Spanish version of Self-care Scale.
Minimum-maximum values: 9-45; higher scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
|
Assessment of a change in self-care
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
Score calculations from the validated original Spanish version of Self-care Scale.
Minimum-maximum values: 9-45; higher scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
|
Assessment of a change in self-care
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
Score calculations from the validated original Spanish version of Self-care Scale.
Minimum-maximum values: 9-45; higher scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
|
Assessment of a change in self-awareness
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
Score calculations from the validated Spanish version of the Five Facet Mindfulness Questionnaire (FFMQ).
Minimum-maximum values: 15-75; higher scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
|
Assessment of a change in self-awareness
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Five Facet Mindfulness Questionnaire (FFMQ).
Minimum-maximum values: 15-75; higher scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
|
Assessment of a change in self-awareness
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Five Facet Mindfulness Questionnaire (FFMQ).
Minimum-maximum values: 15-75; higher scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
|
Assessment of a change in empathy
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
Score calculations from the validated Spanish version of the Interpersonal Reactivity Index (IRI).
Minimum-maximum values: 28-140, higher scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
|
Assessment of a change in empathy
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Interpersonal Reactivity Index (IRI).
Minimum-maximum values: 28-140, higher scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
|
Assessment of a change in empathy
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Interpersonal Reactivity Index (IRI).
Minimum-maximum values: 28-140, higher scores mean better outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
|
Assessment of a change in compassion
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
Score calculations from the validated Spanish version of the Compassion and Satisfaction Fatigue Test (ProQoL version IV).
Minimum-maximum values in each subscale: 10-50; Compassion satisfaction subscale: higher scores mean better outcome; Burnout subscale: higher scores mean a worse outcome; Secondary traumatic stress subscale: higher scores mean a worse outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
|
Assessment of a change in compassion
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Compassion and Satisfaction Fatigue Test (ProQoL version IV).
Minimum-maximum values in each subscale: 10-50; Compassion satisfaction subscale: higher scores mean better outcome; Burnout subscale: higher scores mean a worse outcome; Secondary traumatic stress subscale: higher scores mean a worse outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
|
Assessment of a change in compassion
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Compassion and Satisfaction Fatigue Test (ProQoL version IV).
Minimum-maximum values in each subscale: 10-50; Compassion satisfaction subscale: higher scores mean better outcome; Burnout subscale: higher scores mean a worse outcome; Secondary traumatic stress subscale: higher scores mean a worse outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
|
Assessment of a change in fear of death
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
Score calculations from the validated Spanish version of the Collett-Lester Fear of Death Scale.
Minimum-maximum values in each subscale: 7-35; higher scores mean worse outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
|
|
Assessment of a change in fear of death
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Collett-Lester Fear of Death Scale.
Minimum-maximum values in each subscale: 7-35; higher scores mean worse outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 3 months follow up after cycle completion.
|
|
Assessment of a change in fear of death
Time Frame: From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
Score calculations from the validated Spanish version of the Collett-Lester Fear of Death Scale.
Minimum-maximum values in each subscale: 7-35; higher scores mean worse outcome.
|
From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative aspects gathered from the intervention
Time Frame: At 1 week after art therapy sessions cycle completion.
|
Information gathered through a semi-structured questionnaire produced by the research team, about perceived helpfulness, emotions and sensations, preferences and drawbacks, learnings, expectation of a professional and/or personal impact.
|
At 1 week after art therapy sessions cycle completion.
|
|
Qualitative aspects gathered from the intervention
Time Frame: At 3 months follow up after art therapy sessions cycle completion.
|
Information gathered through a semi-structured questionnaire produced by the research team, about perceived helpfulness, emotions and sensations, preferences and drawbacks, learnings, expectation of a professional and/or personal impact.
|
At 3 months follow up after art therapy sessions cycle completion.
|
|
Qualitative aspects gathered from the intervention
Time Frame: At 6 months follow up after art therapy sessions cycle completion.
|
Information gathered through a semi-structured questionnaire produced by the research team, about perceived helpfulness, emotions and sensations, preferences and drawbacks, learnings, expectation of a professional and/or personal impact.
|
At 6 months follow up after art therapy sessions cycle completion.
|
|
Perception of a change process
Time Frame: At 1 week after art therapy sessions cycle completion.
|
Audio recording interview and verbatim transcription to explore a possible experience of a change process.
|
At 1 week after art therapy sessions cycle completion.
|
|
Perception of a change process
Time Frame: At 3 months follow up after art therapy sessions cycle completion.
|
Audio recording interview and verbatim transcription to explore a possible experience of a change process.
|
At 3 months follow up after art therapy sessions cycle completion.
|
|
Perception of a change process
Time Frame: At 6 months follow up after art therapy sessions cycle completion.
|
Audio recording interview and verbatim transcription to explore a possible experience of a change process.
|
At 6 months follow up after art therapy sessions cycle completion.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Antonio Pascual López, MD, Santa Creu i Sant Pau Hospital, Palliative Care Unit Director.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIBSP-ART-2022-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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