MenopauseNCT06579118
The Impact of Laughter Yoga on Symptom Management and Quality of Life in Postmenopausal Women
A study testing Laughter yoga in people with Menopause, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to assess the impact of laughter yoga intervention on symptomatology and quality of life among postmenopausal women.The research was conducted in a randomized controlled experimental design. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Laughter yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2023to 28 Aug 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Entering natural menopause,
- Being over 45 years old,
- Being at least a primary school graduate (in order to be able to fill out the forms),
- Agreeing to participate in the research voluntarily,
- Not having any hearing or vision problems (in order to be able to perform the sessions),
- No diagnosed psychiatric disease,
Show all 9Show fewer
- Knowing Turkish,
- Having a smart mobile phone
- Being open to communication and cooperation.
Who cannot join
- Not continuing with laughter yoga sessions.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to assess the impact of laughter yoga intervention on symptomatology and quality of life among postmenopausal women.The research was conducted in a randomized controlled experimental design.
Read the detailed description
The population of the research consisted of menopausal women who applied to the Gynecology Polyclinic of Atatürk University Health Research and Application Center between 25.08.2023 and 15.12.2023. To determine the sample size of the study, a priori power analysis was performed in the G* Power 3.1.9.7 program. Based on the medium effect size (0.5), the alpha value was determined as 5% and the theoretical power was determined as 95%, and the minimum sample size was determined as 64. The sample of the study consisted of 128 women, 64 experimental and 64 control, who met the research criteria and agreed to participate in the research. However, since 8 people in the experimental group could not continue laughter yoga, the study was completed with 120 women.
Criteria for inclusion in the study
- Entering natural menopause,
- Being over 45 years old,
- Being at least a primary school graduate (in order to be able to fill out the forms),
- Agreeing to participate in the research voluntarily,
- Not having any hearing or vision problems (in order to be able to perform the sessions),
- No diagnosed psychiatric disease,
- Knowing Turkish,
- Having a smart mobile phone
- Being open to communication and cooperation.
Exclusion criteria from the study
- Not continuing with laughter yoga sessions.
Data were collected using the "Personal Information Form," "Menopause Rating Scale," and "Menopause-Specific Quality of Life Scale." Laughter yoga was used as an intervention tool in the research.Participants in the experimental group underwent laughter yoga sessions twice weekly for four weeks, totaling eight sessions.
The data were collected by the researcher through a face-to-face interview in a suitable empty room at Atatürk University Health Research and Application Center Gynecology Polyclinic. In order to enable women to answer the questions comfortably, each woman was interviewed alone in a separate room in the relevant outpatient clinic. Application of the questionnaire and scales took an average of 10-15 minutes for each woman. Before starting the research, women were informed about the purpose, method, rights and responsibilities of the research.
Process steps experimental group
- Written consent was obtained from menopausal women who agreed to participate in the study.
- 10 minutes before starting the laughter yoga, women in menopause were asked to fill out the \"Personal Information Form\", \"Menopause Rating Scale\" and \"Menopause-Specific Quality of Life Scale\" in order to determine their descriptive characteristics.
- A total of 8 sessions of laughter yoga were applied for 4 weeks, 2 sessions per week. The first session lasted 45 minutes, all other sessions lasted an average of 30 minutes. In the first session, laughter yoga, its history, benefits, breathing techniques, laughter yoga exercises were mentioned before the exercises, and in the following sessions, reminders were made and the session ended with laughter yoga exercises and breathing exercises.
- After 4 weeks, the process was completed by having women in menopause fill out the \"Menopause Rating Scale\" and the \"Menopause-Specific Quality of Life Scale\". control group
- Written consent was obtained from pregnant women who agreed to participate in the study.
- In order to determine the descriptive characteristics of menopausal women, they were asked to fill out the \"Personal Information Form\", \"Menopause Symptoms Evaluation Scale\" and \"Menopause-Specific Quality of Life Scale\".
- After 4 weeks, the process was completed by having women in menopause fill out the \"Menopause Rating Scale\" and \"Menopause-Specific Quality of Life Scale\".
Data analysis included Skewness and Kurtosis values, frequency and percentage distributions, Chi-square tests, Independent Samples t-test, Paired Samples t-test, Mann-Whitney U test, Wilcoxon signed-rank test, and regression analysis. All ethical principles were adhered to throughout the study.
- Conditions
- Menopause
- Being tested
- Laughter yoga
- Keywords
- laughter yoga, menopause, symptom, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yogaOther
The women in the experimental group were given laughter yoga sessions by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | In order to have laughter yoga as a nursing intervention, a "laughter yoga leadership certificate" was obtained by the researcher. Mobile phone numbers were taken to contact the women.Laughter sessions were held in an empty room in the Gynecology outpatient clinic, away from the other rooms indicated by the nurse.A total of 8 sessions of laughter yoga were applied for 4 weeks,2 sessions per week.Before starting laughter yoga, 8 separate WhatsApp groups consisting of approximately 8 people were established to ensure faster and easier communication with women, and information was provided about the sessions and communication was provided. In consultation with the women, the appropriate day, time and program for the session were determined.Sessions will be held twice a week;It was done between 13.00-13.45 on Mondays and Fridays.The sessions were performed in an empty room in the outpatient clinic.A warning sign was hung on the door to avoid being disturbed during the application. Receives: Other: Laughter yoga |
| Control group | No intervention | * Written consent was obtained from pregnant women who agreed to participate in the study. * In order to determine the descriptive characteristics of menopausal women, they were asked to fill out the "Personal Information Form", "Menopause Rating Scale" and "Menopause-Specific Quality of Life Scale". * After 4 weeks, the process was completed by having women in menopause fill out the "Menopause Symptoms Assessment Scale/MSDS" and "Menopause-Specific Quality of Life Scale/MSDS". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
It consists of 10 questions (age, gender, education level, marital status, income status, etc.) prepared by the researcher in line with the literature.
Measured: 5 months
Menopause Rating Scale
The scale, which includes a total of 11 items including menopausal complaints, consists of 3 sub-dimensions. These sub-dimensions are 1-Somatic complaints sub-dimension (items 1,2,3,11), 2-Psychological complaints sub-dimension (items 4,5,6,7), 3-Urogenital complaints sub-dimension (8,9, Article 10). The scale is a 5-point Likert type and each statement is scored as 0: None, 1: Mild, 2: Moderate, 3: Severe and 4: Very severe. The total score of the scale is calculated based on the scores given for each item. The minimum score that can be obtained from the scale is 0, while the maximum score is 44. An increase in the total score obtained from the scale, on the one hand, indicates an increase in the severity of the complaints experienced, and on the other hand, indicates that the quality of life is negatively affected.
Measured: 5 months
Menopause-Specific Quality of Life Scale
It is a Likert type scale containing 29 questions. It consists of four subdomains: vasomotor domain (questions 1-3), psychosocial domain (questions 4-10), physical domain (questions 11-26) and sexual domain (questions 27-29). The complaints that women have experienced in the last month are questioned and the answers to the questions are "yes" or "no". In MÖYÖS, each subdomain score is ranked from 0 to 6. A score of "0" indicates that there are no problems with the issue. A score of "1" indicates that the problem exists and is experienced, but it is not disturbing at all, and scores between "2-6" indicate the severity and increasing degrees of the existing problem. The lowest score that can be obtained from the total of the scale is "0" and the highest score (29X6) is 154. However, evaluation is not made based on the total score.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start25 Aug 2023
- Primary completion15 Dec 2023
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Aydin, Ataturk University
- Investigators
- Ayşe Aydın, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579118
- Sponsor's protocol ID
- Tuba Çelik
- Status last verified
- Dec 2025
- First submitted
- 28 Aug 2024
- Last updated
- 17 Dec 2025
- 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Laughter Yoga on Symptom Management and Quality of Life in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06579118
- Acronym / sponsor ID
- Tuba Çelik
- Conditions
- Menopause
- Keywords
- laughter yoga, menopause, symptom, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 30 Aug 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.
This study aimed to assess the impact of laughter yoga intervention on symptomatology and quality of life among postmenopausal women.The research was conducted in a randomized controlled experimental design.
Detailed description
The population of the research consisted of menopausal women who applied to the Gynecology Polyclinic of Atatürk University Health Research and Application Center between 25.08.2023 and 15.12.2023. To determine the sample size of the study, a priori power analysis was performed in the G* Power 3.1.9.7 program. Based on the medium effect size (0.5), the alpha value was determined as 5% and the theoretical power was determined as 95%, and the minimum sample size was determined as 64. The sample of the study consisted of 128 women, 64 experimental and 64 control, who met the research criteria and agreed to participate in the research. However, since 8 people in the experimental group could not continue laughter yoga, the study was completed with 120 women.
Criteria for inclusion in the study
- Entering natural menopause,
- Being over 45 years old,
- Being at least a primary school graduate (in order to be able to fill out the forms),
- Agreeing to participate in the research voluntarily,
- Not having any hearing or vision problems (in order to be able to perform the sessions),
- No diagnosed psychiatric disease,
- Knowing Turkish,
- Having a smart mobile phone
- Being open to communication and cooperation.
Exclusion criteria from the study
- Not continuing with laughter yoga sessions.
Data were collected using the "Personal Information Form," "Menopause Rating Scale," and "Menopause-Specific Quality of Life Scale." Laughter yoga was used as an intervention tool in the research.Participants in the experimental group underwent laughter yoga sessions twice weekly for four weeks, totaling eight sessions.
The data were collected by the researcher through a face-to-face interview in a suitable empty room at Atatürk University Health Research and Application Center Gynecology Polyclinic. In order to enable women to answer the questions comfortably, each woman was interviewed alone in a separate room in the relevant outpatient clinic. Application of the questionnaire and scales took an average of 10-15 minutes for each woman. Before starting the research, women were informed about the purpose, method, rights and responsibilities of the research.
Process steps experimental group
- Written consent was obtained from menopausal women who agreed to participate in the study.
- 10 minutes before starting the laughter yoga, women in menopause were asked to fill out the \"Personal Information Form\", \"Menopause Rating Scale\" and \"Menopause-Specific Quality of Life Scale\" in order to determine their descriptive characteristics.
- A total of 8 sessions of laughter yoga were applied for 4 weeks, 2 sessions per week. The first session lasted 45 minutes, all other sessions lasted an average of 30 minutes. In the first session, laughter yoga, its history, benefits, breathing techniques, laughter yoga exercises were mentioned before the exercises, and in the following sessions, reminders were made and the session ended with laughter yoga exercises and breathing exercises.
- After 4 weeks, the process was completed by having women in menopause fill out the \"Menopause Rating Scale\" and the \"Menopause-Specific Quality of Life Scale\". control group
- Written consent was obtained from pregnant women who agreed to participate in the study.
- In order to determine the descriptive characteristics of menopausal women, they were asked to fill out the \"Personal Information Form\", \"Menopause Symptoms Evaluation Scale\" and \"Menopause-Specific Quality of Life Scale\".
- After 4 weeks, the process was completed by having women in menopause fill out the \"Menopause Rating Scale\" and \"Menopause-Specific Quality of Life Scale\".
Data analysis included Skewness and Kurtosis values, frequency and percentage distributions, Chi-square tests, Independent Samples t-test, Paired Samples t-test, Mann-Whitney U test, Wilcoxon signed-rank test, and regression analysis. All ethical principles were adhered to throughout the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Laughter yogaIn order to have laughter yoga as a nursing intervention, a "laughter yoga leadership certificate" was obtained by the researcher. Mobile phone numbers were taken to contact the women.Laughter sessions were held in an empty room in the Gynecology outpatient clinic, away from the other rooms indicated by the nurse.A total of 8 sessions of laughter yoga were applied for 4 weeks,2 sessions per week.Before starting laughter yoga, 8 separate WhatsApp groups consisting of approximately 8 people were established to ensure faster and easier communication with women, and information was provided about the sessions and communication was provided. In consultation with the women, the appropriate day, time and program for the session were determined.Sessions will be held twice a week;It was done between 13.00-13.45 on Mondays and Fridays.The sessions were performed in an empty room in the outpatient clinic.A warning sign was hung on the door to avoid being disturbed during the application. |
| Control group | No intervention | –* Written consent was obtained from pregnant women who agreed to participate in the study. * In order to determine the descriptive characteristics of menopausal women, they were asked to fill out the "Personal Information Form", "Menopause Rating Scale" and "Menopause-Specific Quality of Life Scale". * After 4 weeks, the process was completed by having women in menopause fill out the "Menopause Symptoms Assessment Scale/MSDS" and "Menopause-Specific Quality of Life Scale/MSDS". |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Entering natural menopause,
- Being over 45 years old,
- Being at least a primary school graduate (in order to be able to fill out the forms),
- Agreeing to participate in the research voluntarily,
- Not having any hearing or vision problems (in order to be able to perform the sessions),
Key exclusion criteria (1 listed)
- Not continuing with laughter yoga 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 yogaThe women in the experimental group were given laughter yoga sessions by the researcher. | Other | Experimental Group |
Primary outcome
Personal Information Form
Time frame: 5 months
It consists of 10 questions (age, gender, education level, marital status, income status, etc.) prepared by the researcher in line with the literature.
Menopause Rating Scale
Time frame: 5 months
The scale, which includes a total of 11 items including menopausal complaints, consists of 3 sub-dimensions. These sub-dimensions are 1-Somatic complaints sub-dimension (items 1,2,3,11), 2-Psychological complaints sub-dimension (items 4,5,6,7), 3-Urogenital complaints sub-dimension (8,9, Article 10). The scale is a 5-point Likert type and each statement is scored as 0: None, 1: Mild, 2: Moderate, 3: Severe and 4: Very severe. The total score of the scale is calculated based on the scores given for each item. The minimum score that can be obtained from the scale is 0, while the maximum score is 44. An increase in the total score obtained from the scale, on the one hand, indicates an increase in the severity of the complaints experienced, and on the other hand, indicates that the quality of life is negatively affected.
Menopause-Specific Quality of Life Scale
Time frame: 5 months
It is a Likert type scale containing 29 questions. It consists of four subdomains: vasomotor domain (questions 1-3), psychosocial domain (questions 4-10), physical domain (questions 11-26) and sexual domain (questions 27-29). The complaints that women have experienced in the last month are questioned and the answers to the questions are "yes" or "no". In MÖYÖS, each subdomain score is ranked from 0 to 6. A score of "0" indicates that there are no problems with the issue. A score of "1" indicates that the problem exists and is experienced, but it is not disturbing at all, and scores between "2-6" indicate the severity and increasing degrees of the existing problem. The lowest score that can be obtained from the total of the scale is "0" and the highest score (29X6) is 154. However, evaluation is not made based on the total score.
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 17 Dec 2025.
- 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.
Ayşe Aydın principal investigator
Ataturk 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 in people with Menopause, run by Ataturk 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 9 inclusion and 1 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 17 Dec 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?
Personal Information Form (time frame: 5 months). 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 17 Dec 2025.