BurnoutYOGA-CARENCT07786584
Burnout and Well-Being in Healthcare Workers Participating in Workplace Yoga
An observational study of Burnout and Occupational Burnout, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
This study aims to evaluate changes in burnout, perceived stress, coping strategies, anxiety, depression, and psychological well-being among healthcare workers participating in a workplace yoga program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burnout, Occupational Burnout, Yoga Therapy
- What is being tested?
- psychological assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2026to 20 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample size was determined on the basis of a prior calculation carried out using the G*Power software for a pre-post within-subject comparison (t-test for paired data, two-tailed). Assuming a moderate expected effect on the change in burnout scores (Cohen's d = 0.5), a significance level of α = 0.05 and a statistical power (1-β) of 0.95, the required number of participants is 54 subjects with complete measurements at T0 and T1. However, taking into account the possibility of drop-outs, absences exceeding 30% of the sessions or failure to complete the questionnaires at the follow-up, a loss rate of between 15% and 20% is assumed. Based on this estimate, it is therefore anticipated that a total of approximately 65-70 healthcare professionals will be recruited.
Who may be able to join
- Healthcare professionals, including physicians, nurses, physiotherapists, and healthcare support workers.
- Age 18 years or older.
- Voluntary participation in the workplace yoga program.
- Availability to attend at least 70% of the scheduled yoga sessions.
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Medical or physical conditions contraindicating participation in yoga, according to the institutional procedures governing the workplace program.
- Inability to provide informed consent.
- Expected attendance at fewer than 70% of the scheduled sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Pre-Post Study of Burnout, Stress, and Psychological Well-Being in Healthcare Workers Participating in a Workplace Yoga Program
This study aims to evaluate changes in burnout, perceived stress, coping strategies, anxiety, depression, and psychological well-being among healthcare workers participating in a workplace yoga program.
Healthcare professionals are frequently exposed to high emotional demands, workload pressure, irregular shifts, and substantial clinical responsibilities, which may increase the risk of work-related stress and burnout. Workplace-based mind-body activities, including yoga, may support emotional regulation, physical recovery, stress management, and professional well-being.
Read more
Using a prospective pre-post observational design, participants will undergo a multidimensional psychological assessment before starting the workplace yoga program and after completing the 10-week program. The evaluation will include measures of burnout, coping strategies, depressive symptoms, anxiety, and satisfaction with the program.
The findings are expected to improve understanding of the potential association between participation in workplace yoga activities and changes in psychological and occupational well-being among healthcare workers. The results may also provide useful information for the development of organizational initiatives aimed at promoting employee well-being and preventing burnout in healthcare settings.
Read the detailed description
This is an observational, prospective, single-arm pre-post study designed to evaluate changes in burnout, stress-related coping strategies, anxiety, depression, and perceived well-being among healthcare workers participating in an existing workplace yoga program.
The study will be conducted at the IRCCS Centro Neurolesi "Bonino-Pulejo", P.O. "Piemonte", Messina, Italy. The yoga program is an organizational well-being initiative already implemented by the institution and is independent of the present research study. The investigators will not organize, deliver, or modify the yoga sessions and will limit their activities to the collection and analysis of observational data.
The study population will consist of adult healthcare professionals, including physicians, nurses, physiotherapists, and healthcare support workers, who voluntarily participate in the workplace yoga program. Participants must be at least 18 years old and be available to attend at least 70% of the scheduled sessions. Individuals with conditions that contraindicate participation in yoga, according to the institutional procedures governing the program, will not be included.
The workplace yoga program consists of 10 sessions conducted outside working hours. Each session lasts up to 60 minutes and includes three phases: an initial warm-up, a central phase involving yoga postures and breathing techniques, and a final phase involving meditation and relaxation. Sessions are conducted by certified instructors and scheduled according to staff shifts to facilitate access.
Participants will undergo assessment at baseline, before the beginning of the program (T0), and at the end of the 10-week program (T1). The multidimensional assessment includes the Copenhagen Burnout Inventory to evaluate personal, work-related, and patient-related burnout; the Brief Coping Orientation to Problems Experienced to assess coping strategies; the Beck Depression Inventory to measure depressive symptoms; and the State-Trait Anxiety Inventory Form Y to assess state and trait anxiety. At follow-up, participants will also complete an ad hoc satisfaction questionnaire rated on a scale from 0 to 10.
The primary objective is to evaluate the change in burnout levels between baseline and follow-up, measured through the Copenhagen Burnout Inventory total score and its subscales.
Secondary objectives include evaluating changes in coping strategies, depressive symptoms, state anxiety, and trait anxiety. Participant satisfaction with the workplace yoga program will also be described. Exploratory analyses may examine whether changes in psychological outcomes differ according to professional role, workplace site, or level of attendance and whether satisfaction is associated with changes in burnout and psychological well-being.
The study does not involve the collection of clinical data, modification of participants' usual healthcare, or the administration of an experimental intervention. Its prospective observational approach aims to describe psychological and occupational changes associated with voluntary participation in an existing organizational yoga program.
The results may contribute to the development of sustainable workplace well-being initiatives aimed at supporting healthcare professionals, reducing burnout risk, and promoting healthier organizational environments.
- Conditions
- Burnout, Occupational Burnout, Yoga Therapy
- Being tested
- psychological assessment
- Keywords
- healthcare workers, burnout, coping strategies, Psychological Well-Being, Organizational Well-Being
- Medical subject headings
- Burnout, Psychological, Burnout, Professional, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological assessmentBehavioural
Standardized and ad hoc test battery for comprehensive psychological assessment
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers | Burnout Receives: Behavioral: psychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological assessment
Change in Burnout Levels Copenhagen Burnout Inventory (CBI)
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start20 May 2026
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Corallo, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786584
- Sponsor's protocol ID
- CEL/U59/26
- Acronym
- YOGA-CARE
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Pre-Post Study of Burnout, Stress, and Psychological Well-Being in Healthcare Workers Participating in a Workplace Yoga Program
- ClinicalTrials.gov ID
- NCT07786584
- Acronym / sponsor ID
- YOGA-CARE / CEL/U59/26
- Conditions
- Burnout, Occupational Burnout, Yoga Therapy
- Keywords
- healthcare workers, burnout, coping strategies, Psychological Well-Being, Organizational Well-Being
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 26 Aug 2026 (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 aims to evaluate changes in burnout, perceived stress, coping strategies, anxiety, depression, and psychological well-being among healthcare workers participating in a workplace yoga program.
Healthcare professionals are frequently exposed to high emotional demands, workload pressure, irregular shifts, and substantial clinical responsibilities, which may increase the risk of work-related stress and burnout. Workplace-based mind-body activities, including yoga, may support emotional regulation, physical recovery, stress management, and professional well-being.
Using a prospective pre-post observational design, participants will undergo a multidimensional psychological assessment before starting the workplace yoga program and after completing the 10-week program. The evaluation will include measures of burnout, coping strategies, depressive symptoms, anxiety, and satisfaction with the program.
The findings are expected to improve understanding of the potential association between participation in workplace yoga activities and changes in psychological and occupational well-being among healthcare workers. The results may also provide useful information for the development of organizational initiatives aimed at promoting employee well-being and preventing burnout in healthcare settings.
Detailed description
This is an observational, prospective, single-arm pre-post study designed to evaluate changes in burnout, stress-related coping strategies, anxiety, depression, and perceived well-being among healthcare workers participating in an existing workplace yoga program.
The study will be conducted at the IRCCS Centro Neurolesi "Bonino-Pulejo", P.O. "Piemonte", Messina, Italy. The yoga program is an organizational well-being initiative already implemented by the institution and is independent of the present research study. The investigators will not organize, deliver, or modify the yoga sessions and will limit their activities to the collection and analysis of observational data.
The study population will consist of adult healthcare professionals, including physicians, nurses, physiotherapists, and healthcare support workers, who voluntarily participate in the workplace yoga program. Participants must be at least 18 years old and be available to attend at least 70% of the scheduled sessions. Individuals with conditions that contraindicate participation in yoga, according to the institutional procedures governing the program, will not be included.
The workplace yoga program consists of 10 sessions conducted outside working hours. Each session lasts up to 60 minutes and includes three phases: an initial warm-up, a central phase involving yoga postures and breathing techniques, and a final phase involving meditation and relaxation. Sessions are conducted by certified instructors and scheduled according to staff shifts to facilitate access.
Participants will undergo assessment at baseline, before the beginning of the program (T0), and at the end of the 10-week program (T1). The multidimensional assessment includes the Copenhagen Burnout Inventory to evaluate personal, work-related, and patient-related burnout; the Brief Coping Orientation to Problems Experienced to assess coping strategies; the Beck Depression Inventory to measure depressive symptoms; and the State-Trait Anxiety Inventory Form Y to assess state and trait anxiety. At follow-up, participants will also complete an ad hoc satisfaction questionnaire rated on a scale from 0 to 10.
The primary objective is to evaluate the change in burnout levels between baseline and follow-up, measured through the Copenhagen Burnout Inventory total score and its subscales.
Secondary objectives include evaluating changes in coping strategies, depressive symptoms, state anxiety, and trait anxiety. Participant satisfaction with the workplace yoga program will also be described. Exploratory analyses may examine whether changes in psychological outcomes differ according to professional role, workplace site, or level of attendance and whether satisfaction is associated with changes in burnout and psychological well-being.
The study does not involve the collection of clinical data, modification of participants' usual healthcare, or the administration of an experimental intervention. Its prospective observational approach aims to describe psychological and occupational changes associated with voluntary participation in an existing organizational yoga program.
The results may contribute to the development of sustainable workplace well-being initiatives aimed at supporting healthcare professionals, reducing burnout risk, and promoting healthier organizational environments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers | – | Behavioral: psychological assessmentBurnout |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size was determined on the basis of a prior calculation carried out using the G*Power software for a pre-post within-subject comparison (t-test for paired data, two-tailed). Assuming a moderate expected effect on the change in burnout scores (Cohen's d = 0.5), a significance level of α = 0.05 and a statistical power (1-β) of 0.95, the required number of participants is 54 subjects with complete measurements at T0 and T1. However, taking into account the possibility of drop-outs, absences exceeding 30% of the sessions or failure to complete the questionnaires at the follow-up, a loss rate of between 15% and 20% is assumed. Based on this estimate, it is therefore anticipated that a total of approximately 65-70 healthcare professionals will be recruited.
Key inclusion criteria (5 listed)
- Healthcare professionals, including physicians, nurses, physiotherapists, and healthcare support workers.
- Age 18 years or older.
- Voluntary participation in the workplace yoga program.
- Availability to attend at least 70% of the scheduled yoga sessions.
- Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (3 listed)
- Medical or physical conditions contraindicating participation in yoga, according to the institutional procedures governing the workplace program.
- Inability to provide informed consent.
- Expected attendance at fewer than 70% of the scheduled sessions.
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 |
|---|---|---|
| psychological assessmentStandardized and ad hoc test battery for comprehensive psychological assessment | Behavioural | Healthcare workers |
Primary outcome
Psychological assessment
Time frame: Baseline and 10 weeks
Change in Burnout Levels Copenhagen Burnout Inventory (CBI)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Burnout and Occupational Burnout, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Psychological assessment (time frame: Baseline and 10 weeks). 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 26 Aug 2026.