Mental HealthNCT06161623
The Effect of Laughter Yoga on Perceived Stress, Work Motivation, and Mental Well-Being
A study testing Laughter Yoga Application in people with Mental Health and Complementary Therapies, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled experimental study is to examine the effect of laughter yoga applied to intensive care nurses on perceived stress, work motivation, and mental well-being. Read more about this study
- Who is it for?
- Ages 22 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Complementary Therapies
- What is being tested?
- Laughter Yoga Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2022to 1 Mar 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 22 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who have worked as intensive care nurses for at least 6 months
- Those who agree to participate in the research
Who cannot join
- Those with chronic cough
- Those who have previously received laughter yoga training and practiced
- Those who had surgery within the last 3 months
- Those with diagnosed mental illness and those using medication (antidepressants, antipsychotics,anxiolytic, etc…)
- Those who have neurological diseases such as epilepsy and multiple sclerosis
- Those who have recently experienced a loss (within at least 6 months)
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- Those with neurological disorders
- Those who have urinary incontinence problems
- Those who did not agree to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Laughter Yoga Applied to Intensive Care Nurses on Perceived Stress, Work Motivation, and Mental Well-Being
The aim of this randomized controlled experimental study is to examine the effect of laughter yoga applied to intensive care nurses on perceived stress, work motivation, and mental well-being.
Read the detailed description
The study was conducted with nurses working at Manisa Celal Bayar University Hospital's Surgical Intensive Care and Anesthesia Intensive Care units between December 2022 and March 2023. The Nurse Introduction Form, Nurse Work Motivation Scale, Perceived Stress Scale, and Warwick-Edinburgh Mental Well-being Scale were used to collect data.
- Conditions
- Mental Health, Complementary Therapies
- Being tested
- Laughter Yoga Application
- Keywords
- Laughter yoga, Perceived stress, Work motivation, Mental well-being
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter Yoga ApplicationBehavioural
The intervention group took eight sessions of laughter yoga, that is, two sessions per week for 4 weeks. The participants in the intervention group were asked to fill in the data collection tools before the laughter yoga sessions, and after the 4th and 8th yoga sessions.
| Study group | Role | What they receive |
|---|---|---|
| Laughter Yoga Application | Experimental | The intervention group took eight sessions of laughter yoga, that is, two sessions per week for 4 weeks. The participants in the intervention group were asked to fill in the data collection tools before the laughter yoga sessions, and after the 4th and 8th yoga sessions Receives: Behavioral: Laughter Yoga Application |
| Control group | No intervention | The participants in the control group also filled in the data collection tools without undergoing any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Motivation
Work Motivation Scale was used. The highest score the scale can get in total is 75, while the lowest score is 25.
High scale scores mean that nurses have high work motivation.
Measured: 2 weeks
Perceived Stress
Perceived Stress Scale was used. A high total score on the scale indicates that the individual perceives high stress.
High scores on the subscales are generally interpreted as negative.
Measured: 2 weeks
Mental Well-being
Warwick-Edinburgh Mental Well-being Scale was used. It can score between a minimum of 14 and a maximum of 70 points.
High scores indicate that the individual is in a good psychological state.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start21 Dec 2022
- Primary completion6 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramazan Yılmaz, Principal investigator, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161623
- Sponsor's protocol ID
- MCBU-K-CEVIK-002
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be given if it's necessary and if it is not problem for ethical office.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga Applied to Intensive Care Nurses on Perceived Stress, Work Motivation, and Mental Well-Being
- ClinicalTrials.gov ID
- NCT06161623
- Acronym / sponsor ID
- MCBU-K-CEVIK-002
- Conditions
- Mental Health, Complementary Therapies
- Keywords
- Laughter yoga, Perceived stress, Work motivation, Mental well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 Dec 2023 (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 aim of this randomized controlled experimental study is to examine the effect of laughter yoga applied to intensive care nurses on perceived stress, work motivation, and mental well-being.
Detailed description
The study was conducted with nurses working at Manisa Celal Bayar University Hospital's Surgical Intensive Care and Anesthesia Intensive Care units between December 2022 and March 2023. The Nurse Introduction Form, Nurse Work Motivation Scale, Perceived Stress Scale, and Warwick-Edinburgh Mental Well-being Scale were used to collect data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laughter Yoga Application | Experimental | Behavioral: Laughter Yoga ApplicationThe intervention group took eight sessions of laughter yoga, that is, two sessions per week for 4 weeks. The participants in the intervention group were asked to fill in the data collection tools before the laughter yoga sessions, and after the 4th and 8th yoga sessions |
| Control group | No intervention | –The participants in the control group also filled in the data collection tools without undergoing any intervention. |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Those who have worked as intensive care nurses for at least 6 months
- Those who agree to participate in the research
Key exclusion criteria (9 listed)
- Those with chronic cough
- Those who have previously received laughter yoga training and practiced
- Those who had surgery within the last 3 months
- Those with diagnosed mental illness and those using medication (antidepressants, antipsychotics,anxiolytic, etc…)
- Those who have neurological diseases such as epilepsy and multiple sclerosis
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 Yoga ApplicationThe intervention group took eight sessions of laughter yoga, that is, two sessions per week for 4 weeks. The participants in the intervention group were asked to fill in the data collection tools before the laughter yoga sessions, and after the 4th and 8th yoga sessions. | Behavioural | Laughter Yoga Application |
Primary outcome
Work Motivation
Time frame: 2 weeks
Work Motivation Scale was used. The highest score the scale can get in total is 75, while the lowest score is 25. High scale scores mean that nurses have high work motivation.
Perceived Stress
Time frame: 2 weeks
Perceived Stress Scale was used. A high total score on the scale indicates that the individual perceives high stress. High scores on the subscales are generally interpreted as negative.
Mental Well-being
Time frame: 2 weeks
Warwick-Edinburgh Mental Well-being Scale was used. It can score between a minimum of 14 and a maximum of 70 points. High scores indicate that the individual is in a good psychological state.
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 8 Dec 2023.
- Individual participant dataSharing planned: No. The data will be given if it's necessary and if it is not problem for ethical office.
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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.
Ramazan Yılmaz principal investigator
Manisa Celal Bayar University
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 Application in people with Mental Health and Complementary Therapies, run by Manisa Celal Bayar 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 2 inclusion and 9 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 8 Dec 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 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?
Work Motivation (time frame: 2 weeks). 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 8 Dec 2023.