BurnoutNCT07015372
The Effect of Laughter Yoga on Stress, Burnout, and General Health in Psychiatric Nurses
A study testing Laughter Yoga in people with Burnout and Perceived Stress, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effects of laughter yoga on general health, perceived stress, and burnout among psychiatric nurses. Nurses working in psychiatric units are often exposed to high levels of occupational stress, which may impact their well-being and job performance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burnout, Perceived Stress, Occupational Stress
- What is being tested?
- Laughter Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 1 Sep 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being a psychiatric nurse at the specified hospital
- Volunteering to participate
- Not receiving psychiatric treatment currently
Who cannot join
- Chronic physical illnesses that could interfere
- Inability to attend all sessions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erenköy Ruh ve Sinir Hastalıkları Hastanesi
Istanbul
About this study
Official title: The Effect of Laughter Yoga on General Health Status, Perceived Stress Level, and Burnout in Psychiatric Nurses: A Randomized Controlled Trial
This study aims to examine the effects of laughter yoga on general health, perceived stress, and burnout among psychiatric nurses. Nurses working in psychiatric units are often exposed to high levels of occupational stress, which may impact their well-being and job performance. This trial was designed to evaluate the potential benefits of laughter yoga as a supportive intervention in this context.
Read the detailed description
Psychiatric nurses frequently face emotionally intense situations, aggressive patient behaviors, and heavy workloads. These factors are known to contribute to elevated stress levels and burnout.
This study was conducted as a randomized controlled trial at a psychiatric hospital located on the Anatolian side of Istanbul, Türkiye. A total of 70 psychiatric nurses voluntarily participated and were randomly assigned to either an experimental group or a control group (n=35 per group).
The experimental group received an eight-session laughter yoga program, with each session lasting approximately 30 minutes. Sessions were held face-to-face in small groups and facilitated by a trained laughter yoga instructor. Each session included four components: warm-up and clapping exercises, deep breathing, childlike playfulness, and structured laughter activities. The control group received no intervention during the study period.
Data were collected before and after the intervention using the following validated tools:
Nurse Demographic Information Form
Maslach Burnout Inventory (MBI)
Perceived Stress Scale (PSS-10)
General Health Questionnaire (GHQ-28)
The study was approved by the relevant ethics committee, and all participants provided informed consent prior to enrollment.
- Being tested
- Laughter Yoga
- Keywords
- Laughter Yoga, Maslach Burnout Inventory, PSS-10, GHQ-28, Psychiatric Nurses, Nursing Interventions, Mental Health Promotion, Complementary Therapies, Burnout Prevention, Stress Reduction, Workplace Wellness
- Medical subject headings
- Burnout, Psychological, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter YogaBehavioural
Laughter yoga intervention including clapping, breathing, childlike play, and laughter exercises, delivered in 8 sessions over 4 weeks to reduce stress and burnout and improve general health among psychiatric nurses.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Laughter Yoga | Experimental | Participants in this group received a structured laughter yoga program consisting of 8 sessions over approximately four weeks. Each session lasted about 30 minutes and included clapping, breathing exercises, playful activities, and laughter exercises. Sessions were delivered face-to-face in small groups. Receives: Behavioral: Laughter Yoga |
| Control: No Intervention | No intervention | Participants in this group did not receive any intervention during the study period. They continued their usual routines and duties. The same pre- and post-test assessments were applied as in the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maslach Burnout Inventory (MBI) Total Score
The Maslach Burnout Inventory (MBI) is used to assess burnout levels among psychiatric nurses. Scores range from low to high burnout. A decrease in score indicates reduced burnout. The scale has three subscales: emotional exhaustion, depersonalization, and personal accomplishment.
Measured: Baseline and after 4 weeks (post-intervention)
Change in Perceived Stress Level (PSS-10 Total Score)
Perceived stress is measured using the 10-item Perceived Stress Scale (PSS-10). Total scores range from 0 to 40, with higher scores indicating greater perceived stress. A decrease in score reflects improvement.
Measured: Baseline and Week 4 (post-intervention)
Change in General Health Status (GHQ-28 Total Score)
General health is evaluated using the General Health Questionnaire-28 (GHQ-28), which includes somatic symptoms, anxiety/insomnia, social dysfunction, and severe depression subscales. Total scores range from 0 to 28, with lower scores indicating better general health status.
Measured: Baseline and Week 4 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jul 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
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.
- More trials run by Bezmialem Vakif UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to two parallel groups: an experimental group receiving a structured laughter yoga program, and a control group receiving no intervention during the study period.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe DOST, Bezmialem Vakif University
- Investigators
- Ayşe V Dost, Study director, Bezmialem Vakıf Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015372
- Sponsor's protocol ID
- 2023_Dost_LaughterYoga
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset is currently being used for the preparation of a scientific publication. Data sharing may be considered after the publication process is complete, upon reasonable request and with appropriate approvals.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on General Health Status, Perceived Stress Level, and Burnout in Psychiatric Nurses: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07015372
- Acronym / sponsor ID
- 2023_Dost_LaughterYoga
- Keywords
- Laughter Yoga, Maslach Burnout Inventory, PSS-10, GHQ-28, Psychiatric Nurses, Nursing Interventions, Mental Health Promotion, Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 11 Jun 2025 (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 examine the effects of laughter yoga on general health, perceived stress, and burnout among psychiatric nurses. Nurses working in psychiatric units are often exposed to high levels of occupational stress, which may impact their well-being and job performance. This trial was designed to evaluate the potential benefits of laughter yoga as a supportive intervention in this context.
Detailed description
Psychiatric nurses frequently face emotionally intense situations, aggressive patient behaviors, and heavy workloads. These factors are known to contribute to elevated stress levels and burnout.
This study was conducted as a randomized controlled trial at a psychiatric hospital located on the Anatolian side of Istanbul, Türkiye. A total of 70 psychiatric nurses voluntarily participated and were randomly assigned to either an experimental group or a control group (n=35 per group).
The experimental group received an eight-session laughter yoga program, with each session lasting approximately 30 minutes. Sessions were held face-to-face in small groups and facilitated by a trained laughter yoga instructor. Each session included four components: warm-up and clapping exercises, deep breathing, childlike playfulness, and structured laughter activities. The control group received no intervention during the study period.
Data were collected before and after the intervention using the following validated tools:
Nurse Demographic Information Form
Maslach Burnout Inventory (MBI)
Perceived Stress Scale (PSS-10)
General Health Questionnaire (GHQ-28)
The study was approved by the relevant ethics committee, and all participants provided informed consent prior to enrollment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to two parallel groups: an experimental group receiving a structured laughter yoga program, and a control group receiving no intervention during the study period.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Laughter Yoga | Experimental | Behavioral: Laughter YogaParticipants in this group received a structured laughter yoga program consisting of 8 sessions over approximately four weeks. Each session lasted about 30 minutes and included clapping, breathing exercises, playful activities, and laughter exercises. Sessions were delivered face-to-face in small groups. |
| Control: No Intervention | No intervention | –Participants in this group did not receive any intervention during the study period. They continued their usual routines and duties. The same pre- and post-test assessments were applied as in the experimental group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being a psychiatric nurse at the specified hospital
- Volunteering to participate
- Not receiving psychiatric treatment currently
Key exclusion criteria (2 listed)
- Chronic physical illnesses that could interfere
- Inability to attend all 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 |
|---|---|---|
| Laughter YogaLaughter yoga intervention including clapping, breathing, childlike play, and laughter exercises, delivered in 8 sessions over 4 weeks to reduce stress and burnout and improve general health among psychiatric nurses. | Behavioural | Experimental: Laughter Yoga |
Primary outcome
Change in Maslach Burnout Inventory (MBI) Total Score
Time frame: Baseline and after 4 weeks (post-intervention)
The Maslach Burnout Inventory (MBI) is used to assess burnout levels among psychiatric nurses. Scores range from low to high burnout. A decrease in score indicates reduced burnout. The scale has three subscales: emotional exhaustion, depersonalization, and personal accomplishment.
Change in Perceived Stress Level (PSS-10 Total Score)
Time frame: Baseline and Week 4 (post-intervention)
Perceived stress is measured using the 10-item Perceived Stress Scale (PSS-10). Total scores range from 0 to 40, with higher scores indicating greater perceived stress. A decrease in score reflects improvement.
Change in General Health Status (GHQ-28 Total Score)
Time frame: Baseline and Week 4 (post-intervention)
General health is evaluated using the General Health Questionnaire-28 (GHQ-28), which includes somatic symptoms, anxiety/insomnia, social dysfunction, and severe depression subscales. Total scores range from 0 to 28, with lower scores indicating better general health status.
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 11 Jun 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset is currently being used for the preparation of a scientific publication. Data sharing may be considered after the publication process is complete, upon reasonable request and with appropriate approvals.
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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.
Ayşe V Dost study director
Bezmialem Vakıf Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter Yoga in people with Burnout and Perceived Stress, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 11 Jun 2025. 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 Turkey (Türkiye). 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 Maslach Burnout Inventory (MBI) Total Score (time frame: Baseline and after 4 weeks (post-intervention)). 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 11 Jun 2025.