Work-Related StressATMIRNCT05654376
Art Therapy to Promote Wellbeing and Self-care in Resident Physicians.
A study testing Art therapy in people with Work-Related Stress, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
This study evaluates if an art therapy intervention could lower resident physician's work-related stress and if it could promote their self-care. Read more about this study
- Who is it for?
- Ages 23 years and older
- Conditions the study is for
- Work-Related Stress
- What is being tested?
- Art therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2022to Jun 2024
- Phase
- Interventional
- 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 23 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- belonging to the resident physicians collective of the Santa Creu i Sant Pau Hospital.
Who cannot join
- being with a diagnostic of major depression
- receiving psychotherapy o similar
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates if an art therapy intervention could lower resident physician's work-related stress and if it could promote their self-care.
Read the 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.
- Conditions
- Work-Related Stress
- Being tested
- Art therapy
- Keywords
- Resident physician, Art therapy, Self-awareness, Sel-Care
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art therapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Group art therapy | Experimental | Cycle of 6 2-hours bimonthly group art therapy sessions. Receives: Behavioral: Art therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of a change in burnout level
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.
Measured: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
Assessment of a change in burnout level
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.
Measured: 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
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.
Measured: From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
Secondary outcomes (21)
Assessment of a change in work-related stress
Score calculations from the validated Spanish version of the Perceived Stress Scale (PFS 14). Minimum-maximum values: 0-56; lower scores mean better outcome.
Measured: 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
Score calculations from the validated Spanish version of the Perceived Stress Scale (PFS 14). Minimum-maximum values: 0-56; lower scores mean better outcome.
Measured: 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
Score calculations from the validated Spanish version of the Perceived Stress Scale (PFS 14). Minimum-maximum values: 0-56; lower scores mean better outcome.
Measured: 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
Score calculations from the validated Spanish version of the Five Facet Mindfulness Questionnaire (FFMQ). Minimum-maximum values: 15-75; higher scores mean better outcome.
Measured: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
Assessment of a change in self-awareness
Score calculations from the validated Spanish version of the Five Facet Mindfulness Questionnaire (FFMQ). Minimum-maximum values: 15-75; higher scores mean better outcome.
Measured: 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
Score calculations from the validated Spanish version of the Five Facet Mindfulness Questionnaire (FFMQ). Minimum-maximum values: 15-75; higher scores mean better outcome.
Measured: 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
Score calculations from the validated Spanish version of the Interpersonal Reactivity Index (IRI). Minimum-maximum values: 28-140, higher scores mean better outcome.
Measured: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
Assessment of a change in empathy
Score calculations from the validated Spanish version of the Interpersonal Reactivity Index (IRI). Minimum-maximum values: 28-140, higher scores mean better outcome.
Measured: 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
Score calculations from the validated Spanish version of the Interpersonal Reactivity Index (IRI). Minimum-maximum values: 28-140, higher scores mean better outcome.
Measured: 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
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.
Measured: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
Assessment of a change in compassion
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.
Measured: 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
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.
Measured: 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
Score calculations from the validated Spanish version of the Professional Quality of Life Scale. Minimum-maximum values: 9-45; lower scores mean better outcome.
Measured: 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
Score calculations from the validated Spanish version of the Professional Quality of Life Scale. Minimum-maximum values: 9-45; lower scores mean better outcome.
Measured: 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
Score calculations from the validated Spanish version of the Professional Quality of Life Scale. Minimum-maximum values: 9-45; lower scores mean better outcome.
Measured: 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
Score calculations from the validated original Spanish version of Self-care Scale. Minimum-maximum values: 9-45; higher scores mean better outcome.
Measured: From baseline assessed 1 week before art therapy sessions cycle starting, at 1 week after cycle completion.
Assessment of a change in self-care
Score calculations from the validated original Spanish version of Self-care Scale. Minimum-maximum values: 9-45; higher scores mean better outcome.
Measured: 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
Score calculations from the validated original Spanish version of Self-care Scale. Minimum-maximum values: 9-45; higher scores mean better outcome.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From baseline assessed 1 week before art therapy sessions cycle starting, at 6 months follow up after cycle completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Dec 2022
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work-Related StressStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Pascual López, MD, Principal investigator, Santa Creu i Sant Pau Hospital, Palliative Care Unit Director.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654376
- Sponsor's protocol ID
- IIBSP-ART-2022-21
- Acronym
- ATMIR
- Status last verified
- Mar 2023
- First submitted
- 23 Nov 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art Therapy to Promote Wellbeing and Self-care in Resident Physicians.
- ClinicalTrials.gov ID
- NCT05654376
- Acronym / sponsor ID
- ATMIR / IIBSP-ART-2022-21
- Conditions
- Work-Related Stress
- Keywords
- Resident physician, Art therapy, Self-awareness, Sel-Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 16 Dec 2022 (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.
This study evaluates if an art therapy intervention could lower resident physician's work-related stress and if it could promote their self-care.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group art therapy | Experimental | Behavioral: Art therapyCycle of 6 2-hours bimonthly group art therapy sessions. |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- belonging to the resident physicians collective of the Santa Creu i Sant Pau Hospital.
Key exclusion criteria (2 listed)
- being with a diagnostic of major depression
- receiving psychotherapy o similar
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 |
|---|---|---|
| Art therapyParticipant'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). | Behavioural | Group art therapy |
Primary outcome
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.
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.
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.
21 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- 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.
Antonio Pascual López, MD principal investigator
Santa Creu i Sant Pau Hospital, Palliative Care Unit Director.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art therapy in people with Work-Related Stress, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Mar 2023. 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 Spain. 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?
Results are not available in the source record.
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?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2023.