BurnoutNCT06642727
The Effect of Laughter Yoga on Nurses' Burnout Level and Stress
A study testing laughter yoga in people with Burnout and Stress, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical trial is to determine the effect of laughter yoga on the burnout levels and stress of nurses. The main questions of the study are as follows: 1. What is the burnout level of nurses in the control and intervention groups? 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- 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
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2024to Jan 2027
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a nurse working day and night shifts
- Not having participated in laughter yoga sessions before
- Being willing to participate in the study
Who cannot join
- Having a physical condition that prevents participation in laughter yoga sessions (hernia, hemorrhoids, vertigo, respiratory disorders, urinary incontinence, epilepsy)
- Not being a nurse
- Working continuously day or continuously night shifts
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bursa Mustafakemalpaşa Public Hospital
Bursa, Mustafakemalpaşa, 16500
bursa mustafakemalpaşa public hospital bursa mustafakemalpaşa public hospital, +90 224 613 18 60 ext. +90 224 613 18, bursadhs6@saglik.gov.tr
ayşe karataş
About this study
Official title: The Effect of Laughter Yoga on Nurses' Burnout Level and Stress: Randomized Controlled Study
The purpose of this clinical trial is to determine the effect of laughter yoga on the burnout levels and stress of nurses. The main questions of the study are as follows:
- What is the burnout level of nurses in the control and intervention groups?
- What is the stress level of nurses in the control and intervention groups?
- Has there been a change in the burnout levels of nurses practicing laughter yoga?
- Has there been a change in the stress levels of nurses practicing laughter yoga? To compare whether laughter yoga affects burnout and stress levels, participants will be divided into control and experimental groups. The experimental group will undergo laughter yoga sessions twice a week for one month.
Read the detailed description
The study examines the stress and burnout levels of nurses and their causes. Stress in nurses arises from factors such as working conditions, compatibility with colleagues, and insufficient equipment, among others. When this stress becomes chronic, it is referred to as burnout. The Maslach Burnout Inventory will be used to assess burnout levels, while the Nurse Stress Scale will be used to assess stress levels. Laughter yoga will be employed as a coping method.
Laughter serves the function of engaging and relaxing effective muscles, improves respiratory functions, regulates blood circulation, reduces stress hormones, boosts the immune system's defenses, raises pain thresholds and tolerance, and enhances mental function. Many studies have observed that the positive effects of laughter yoga on human psychology are beneficial for burnout syndrome. This research will investigate how laughter yoga affects burnout and stress levels.
- Being tested
- laughter yoga
- Keywords
- BURNOUT, stress, nurse, Laughter Yoga
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter yogaBehavioural
Laughter yoga reduces stress levels through sessions lasting approximately 40 minutes without any invasive or pharmacological interventions. It regulates breathing, relaxes muscles, stimulates circulation, increases pain thresholds, strengthens immunity, lightens the mind, enhances social relationships, promotes mental balance, and boosts self-esteem, hope, energy, and quality of life. The content of a session includes deep breathing exercises, warm-up exercises, childlike games, and laughter exercises.
| Study group | Role | What they receive |
|---|---|---|
| the group undergoing laughter yoga | Experimental | Laughter Yoga is a complementary therapy that combines fake and genuine laughter with yoga and breathing exercises, including neck and shoulder exercises. It does not involve humor and is non-pharmacological and non-invasive.
A session of laughter yoga lasts about 40 minutes and consists of four sections. The first section includes deep breathing exercises, the second section consists of warm-up exercises, the third section involves childlike games, and the fourth section includes laughter exercises.
The experimental group will consist of 25 participants. Before starting laughter yoga, the "Maslach Burnout Inventory" and the "Nurse Job Stress Scale" will be used to measure burnout and stress levels. Subsequently, a total of eight laughter yoga sessions will be conducted twice a week for one month, after which burnout and stress levels will be measured again using the scales. Receives: Behavioral: laughter yoga |
| control group | No intervention | The control group will consist of 25 participants, whose burnout and stress levels will be measured only using the "Maslach Burnout Inventory" and the "Nurse Job Stress Scale." No intervention will be applied to the participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maslach burnout ineventory
The scale consists of 22 items in a 5-point Likert format (0: Never, 1: Very Rarely, 2: Sometimes, 3: Often, 4: Always). It has three dimensions: Emotional Exhaustion (EE, 9 items), Depersonalization (D, 5 items), and Personal Accomplishment Deficiency (PAD, 8 items). EE refers to the emotional overload an individual feels due to their work and is the most significant predictor of burnout. D represents attitudes and behaviors exhibited by the individual without regard to the fact that the people they serve are unique individuals, displaying a lack of emotion. PAD is defined as the inability to cope with problems successfully and feeling insufficient.
Individuals experiencing burnout are expected to have high scores in EE (0-36), D (0-20), and PAD (0-32). The Cronbach Alpha coefficients for the three subdimensions of the scale are 0.83 for emotional exhaustion, 0.65 for depersonalization, and 0.72 for personal accomplishment deficiency.
Measured: 1 month
Nurse Stress Scale
The original "Nurse Job Stress Scale," developed by Gray-Toft and Anderson, consists of 34 items and seven factors. These factors include: Uncertainty Related to Treatment (8 items = 1,2,3,4,5,6,7,8), Workload (6 items = 9,10,11,12,13,14), Patient Death (5 items = 15,16,17,18,19), Conflict with Physicians (5 items = 20,21,22,23,24), Conflict with Other Nurses (5 items = 25,26,27,28,29), Inadequate Support (3 items = 30,31,32), and Suffering Patient (2 items = 33,34). It is rated using a 4-point Likert system, where (1 point) means never, (2 points) sometimes, (3 points) often, and (4 points) very often. The Cronbach α reliability coefficient of the original scale has been found to be between α = .89 and α = .65 for the subfactors. A high total score indicates that the nurse experiences more frequent periods of stress related to individual stress issues in the physical, psychological, and environmental contexts.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups: an experimental group and a control group. The experimental group will undergo laughter yoga, while the control group will not receive any intervention.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Karataş, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642727
- Sponsor's protocol ID
- E-66779070-050.04-2400226440
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Nurses' Burnout Level and Stress: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06642727
- Acronym / sponsor ID
- E-66779070-050.04-2400226440
- Keywords
- BURNOUT, stress, nurse, Laughter Yoga
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Oct 2024 (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.
The purpose of this clinical trial is to determine the effect of laughter yoga on the burnout levels and stress of nurses. The main questions of the study are as follows:
- What is the burnout level of nurses in the control and intervention groups?
- What is the stress level of nurses in the control and intervention groups?
- Has there been a change in the burnout levels of nurses practicing laughter yoga?
- Has there been a change in the stress levels of nurses practicing laughter yoga? To compare whether laughter yoga affects burnout and stress levels, participants will be divided into control and experimental groups. The experimental group will undergo laughter yoga sessions twice a week for one month.
Detailed description
The study examines the stress and burnout levels of nurses and their causes. Stress in nurses arises from factors such as working conditions, compatibility with colleagues, and insufficient equipment, among others. When this stress becomes chronic, it is referred to as burnout. The Maslach Burnout Inventory will be used to assess burnout levels, while the Nurse Stress Scale will be used to assess stress levels. Laughter yoga will be employed as a coping method.
Laughter serves the function of engaging and relaxing effective muscles, improves respiratory functions, regulates blood circulation, reduces stress hormones, boosts the immune system's defenses, raises pain thresholds and tolerance, and enhances mental function. Many studies have observed that the positive effects of laughter yoga on human psychology are beneficial for burnout syndrome. This research will investigate how laughter yoga affects burnout and stress levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two groups: an experimental group and a control group. The experimental group will undergo laughter yoga, while the control group will not receive any intervention.
| Arm | Type | Receives |
|---|---|---|
| the group undergoing laughter yoga | Experimental | Behavioral: laughter yogaLaughter Yoga is a complementary therapy that combines fake and genuine laughter with yoga and breathing exercises, including neck and shoulder exercises. It does not involve humor and is non-pharmacological and non-invasive. A session of laughter yoga lasts about 40 minutes and consists of four sections. The first section includes deep breathing exercises, the second section consists of warm-up exercises, the third section involves childlike games, and the fourth section includes laughter exercises. The experimental group will consist of 25 participants. Before starting laughter yoga, the "Maslach Burnout Inventory" and the "Nurse Job Stress Scale" will be used to measure burnout and stress levels. Subsequently, a total of eight laughter yoga sessions will be conducted twice a week for one month, after which burnout and stress levels will be measured again using the scales. |
| control group | No intervention | –The control group will consist of 25 participants, whose burnout and stress levels will be measured only using the "Maslach Burnout Inventory" and the "Nurse Job Stress Scale." No intervention will be applied to the participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being a nurse working day and night shifts
- Not having participated in laughter yoga sessions before
- Being willing to participate in the study
Key exclusion criteria (3 listed)
- Having a physical condition that prevents participation in laughter yoga sessions (hernia, hemorrhoids, vertigo, respiratory disorders, urinary incontinence, epilepsy)
- Not being a nurse
- Working continuously day or continuously night shifts
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 reduces stress levels through sessions lasting approximately 40 minutes without any invasive or pharmacological interventions. It regulates breathing, relaxes muscles, stimulates circulation, increases pain thresholds, strengthens immunity, lightens the mind, enhances social relationships, promotes mental balance, and boosts self-esteem, hope, energy, and quality of life. The content of a session includes deep breathing exercises, warm-up exercises, childlike games, and laughter exercises. | Behavioural | the group undergoing laughter yoga |
Primary outcome
Maslach burnout ineventory
Time frame: 1 month
The scale consists of 22 items in a 5-point Likert format (0: Never, 1: Very Rarely, 2: Sometimes, 3: Often, 4: Always). It has three dimensions: Emotional Exhaustion (EE, 9 items), Depersonalization (D, 5 items), and Personal Accomplishment Deficiency (PAD, 8 items). EE refers to the emotional overload an individual feels due to their work and is the most significant predictor of burnout. D represents attitudes and behaviors exhibited by the individual without regard to the fact that the people they serve are unique individuals, displaying a lack of emotion. PAD is defined as the inability to cope with problems successfully and feeling insufficient. Individuals experiencing burnout are expected to have high scores in EE (0-36), D (0-20), and PAD (0-32). The Cronbach Alpha coefficients for the three subdimensions of the scale are 0.83 for emotional exhaustion, 0.65 for depersonalization, and 0.72 for personal accomplishment deficiency.
Nurse Stress Scale
Time frame: 1 month
The original "Nurse Job Stress Scale," developed by Gray-Toft and Anderson, consists of 34 items and seven factors. These factors include: Uncertainty Related to Treatment (8 items = 1,2,3,4,5,6,7,8), Workload (6 items = 9,10,11,12,13,14), Patient Death (5 items = 15,16,17,18,19), Conflict with Physicians (5 items = 20,21,22,23,24), Conflict with Other Nurses (5 items = 25,26,27,28,29), Inadequate Support (3 items = 30,31,32), and Suffering Patient (2 items = 33,34). It is rated using a 4-point Likert system, where (1 point) means never, (2 points) sometimes, (3 points) often, and (4 points) very often. The Cronbach α reliability coefficient of the original scale has been found to be between α = .89 and α = .65 for the subfactors. A high total score indicates that the nurse experiences more frequent periods of stress related to individual stress issues in the physical, psychological, and environmental contexts.
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 15 Oct 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.
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 Stress, run by Çanakkale Onsekiz Mart 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 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: opening soon, as of the sponsor's last update on 15 Oct 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 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?
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?
Contact Ayşe KARATAŞ (+905455694332 ext. +905455694332, aysek3216@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maslach burnout ineventory (time frame: 1 month). The study lists 2 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 15 Oct 2024.