MenopauseNCT07435545
Effect of Laughter Yoga on Menopausal Symptoms, Sleep, and Quality of Life in Menopausal Women
A study testing Laughter Yoga in people with Menopause, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aims to provide meaningful contributions to both academic literature and clinical nursing practice by examining laughter yoga, a non-pharmacological, evidence-based, and feasible intervention for quality of life and sleep problems commonly encountered during menopause. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Menopause
- 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
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 29 Mar 2026
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being in the menopause period
- Having sufficient proficiency in understanding and expressing oneself in Turkish
- Agreeing to participate in the study
- Having physical and cognitive competence
- Not having a diagnosis of mental disorder
- Not using hormone therapy or complementary treatments for menopause symptoms
Who cannot join
- Not participating in laughter yoga sessions
- Withdrawing from the study during the research phase
- Incomplete filling out of data collection forms
- Having contraindications for laughter yoga (Bleeding hemorrhoids, psychiatric disorders, epilepsy, undergoing surgery within the last 3 months, and similar conditions)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Prof. Dr. Gülten Güvenç, PhD contact
Turkey (Türkiye)1 site
Mamak Aile Merkezleri
Ankara, Ankara, 06260
Derya Uzunca, BSc, RN, 5071720400, deryauzunca673@gmail.com
Prof.Dr. Gülten Güvenç, PhD, gulten.guvenc@sbu.edu.tr
About this study
Official title: Evaluation of the Effects of Laughter Yoga on Menopausal Symptoms, Sleep, and Quality of Life in Menopausal Women
This study aims to provide meaningful contributions to both academic literature and clinical nursing practice by examining laughter yoga, a non-pharmacological, evidence-based, and feasible intervention for quality of life and sleep problems commonly encountered during menopause. Menopause is a natural stage of life that can be associated with physical and psychological symptoms affecting daily life. Laughter yoga, a group-based complementary method, is based on the philosophy that "movement creates emotion" and aims to transform voluntary laughter into natural and genuine laughter over time. Laughter yoga consists of clapping and warm-up exercises, childlike games, deep breathing techniques, laughter exercises, and meditation stages. Thanks to its physiological and psychological effects, it supports individuals' overall well-being.
In this study, participants will be divided into two groups: an intervention group and a control group. A pre-test will be administered to both groups to assess menopause symptoms, sleep quality, and quality of life. The intervention group will undergo eight sessions of laughter yoga, while the control group will not receive any intervention during the study period. A post-test will be administered to both groups after the intervention to evaluate its effectiveness.
The results of the study are expected to contribute to determining whether laughter yoga is an effective supportive approach during menopause. It is particularly important in terms of establishing a scientific basis for the integration of complementary treatment approaches into the menopause period and ensuring that they can be integrated with nursing care.
Read the detailed description
This study is designed as a controlled trial involving women in the menopause period, with participants individually randomized using a simple randomization method. The study will be conducted at a family health center affiliated with the Mamak Cultural Center Coordination in Ankara, Turkey.
Eligible participants will be randomly assigned to either the laughter yoga intervention group or the control group at a 1:1 ratio using a computer-generated randomization sequence. Following the pre-test, the intervention group will receive a total of eight laughter yoga sessions over four weeks, twice a week. No intervention will be administered to the control group during the study period.
Menopause symptoms, sleep quality, and menopause-specific quality of life will be assessed using pre-test and post-test measurements. This study aims to determine the effect of laughter yoga on changes experienced during menopause and on sleep and quality of life.
- Conditions
- Menopause
- Being tested
- Laughter Yoga
- Keywords
- Laughter Yoga, Menopause, Menopausal Symptoms, Sleep Quality, Quality of Life, Non-Pharmacological Intervention, Women's Health, Menopausal Women
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter YogaBehavioural
Also called Laughter Therapy
The intervention consists of a total of 8 laughter yoga sessions, with 2 sessions per week for four weeks. Each laughter yoga session is planned to last an average of 20 minutes. Each session will begin with clapping and warm-up exercises and continue with childlike games, deep breathing exercises, and laughter exercises. It will end with meditation. It is a group-based practice, and the aim is to increase psychosocial well-being by transforming fake laughter into real laughter and to benefit from the physiological effects of laughter.
| Study group | Role | What they receive |
|---|---|---|
| Laughter Yoga Intervention Group | Experimental | Participants in the experimental group will undergo a pre-test to assess menopause symptoms, sleep, and quality of life. After 8 sessions of laughter yoga over 4 weeks, a post-test will be administered to reassess menopause symptoms, sleep, and quality of life. Receives: Behavioral: Laughter Yoga |
| Control Group | No intervention | Arm Description: No intervention will be applied to participants in this group during the study period. A pre-test will be administered at the beginning and a post-test will be administered after 4 weeks to assess menopause symptoms, sleep quality, and quality of life. After the final test, laughter yoga will be practiced to prevent participant bias. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Menopausal Symptoms
Menopause symptoms will be assessed using the Menopause Rating Scale (MRS). Changes in total MRS scores from baseline to post-intervention will be compared between the intervention group and the control group.
Measured: Baseline and immediately after the 4-week intervention
Secondary outcomes (2)
Change in Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Changes in PSQI scores at baseline and after the 4-week intervention will be compared between groups.
Measured: Baseline and immediately after the 4-week intervention
Change in Menopause-Specific Quality of Life
Quality of life will be assessed using the Menopause-Specific Quality of Life Questionnaire (MENQOL). Changes in MENQOL scores at baseline and after the 4-week intervention will be compared between the intervention and control groups.
Measured: Baseline and immediately after the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion29 Mar 2026 (estimated)
- Study completion29 Mar 2026 (estimated)
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 Saglik Bilimleri UniversitesiThe 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
- Model description
- Participants will be randomly assigned to two groups: the intervention group and the control group. A pre-test will be conducted to assess menopause symptoms, sleep quality, and quality of life. While the intervention group will receive eight sessions of laughter yoga, the control group will not receive any intervention during the study period. A final test will be conducted in both groups to assess changes in menopause symptoms, sleep quality, and quality of life. After the final assessments are completed, the control group will also receive the laughter yoga intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Uzunca, Saglik Bilimleri Universitesi
- Investigators
- Prof.Dr. Gülten Güvenç, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435545
- Sponsor's protocol ID
- 2025-033
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in publications, including the analyzable data set, will be shared if the study results are published.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Laughter Yoga on Menopausal Symptoms, Sleep, and Quality of Life in Menopausal Women
- ClinicalTrials.gov ID
- NCT07435545
- Acronym / sponsor ID
- 2025-033
- Conditions
- Menopause
- Keywords
- Laughter Yoga, Menopause, Menopausal Symptoms, Sleep Quality, Quality of Life, Non-Pharmacological Intervention, Women's Health, Menopausal Women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 29 Mar 2026 (estimated)
- Study completion
- 29 Mar 2026 (estimated)
- First posted
- 27 Feb 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 provide meaningful contributions to both academic literature and clinical nursing practice by examining laughter yoga, a non-pharmacological, evidence-based, and feasible intervention for quality of life and sleep problems commonly encountered during menopause. Menopause is a natural stage of life that can be associated with physical and psychological symptoms affecting daily life. Laughter yoga, a group-based complementary method, is based on the philosophy that "movement creates emotion" and aims to transform voluntary laughter into natural and genuine laughter over time. Laughter yoga consists of clapping and warm-up exercises, childlike games, deep breathing techniques, laughter exercises, and meditation stages. Thanks to its physiological and psychological effects, it supports individuals' overall well-being.
In this study, participants will be divided into two groups: an intervention group and a control group. A pre-test will be administered to both groups to assess menopause symptoms, sleep quality, and quality of life. The intervention group will undergo eight sessions of laughter yoga, while the control group will not receive any intervention during the study period. A post-test will be administered to both groups after the intervention to evaluate its effectiveness.
The results of the study are expected to contribute to determining whether laughter yoga is an effective supportive approach during menopause. It is particularly important in terms of establishing a scientific basis for the integration of complementary treatment approaches into the menopause period and ensuring that they can be integrated with nursing care.
Detailed description
This study is designed as a controlled trial involving women in the menopause period, with participants individually randomized using a simple randomization method. The study will be conducted at a family health center affiliated with the Mamak Cultural Center Coordination in Ankara, Turkey.
Eligible participants will be randomly assigned to either the laughter yoga intervention group or the control group at a 1:1 ratio using a computer-generated randomization sequence. Following the pre-test, the intervention group will receive a total of eight laughter yoga sessions over four weeks, twice a week. No intervention will be administered to the control group during the study period.
Menopause symptoms, sleep quality, and menopause-specific quality of life will be assessed using pre-test and post-test measurements. This study aims to determine the effect of laughter yoga on changes experienced during menopause and on sleep and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two groups: the intervention group and the control group. A pre-test will be conducted to assess menopause symptoms, sleep quality, and quality of life. While the intervention group will receive eight sessions of laughter yoga, the control group will not receive any intervention during the study period. A final test will be conducted in both groups to assess changes in menopause symptoms, sleep quality, and quality of life. After the final assessments are completed, the control group will also receive the laughter yoga intervention.
| Arm | Type | Receives |
|---|---|---|
| Laughter Yoga Intervention Group | Experimental | Behavioral: Laughter YogaParticipants in the experimental group will undergo a pre-test to assess menopause symptoms, sleep, and quality of life. After 8 sessions of laughter yoga over 4 weeks, a post-test will be administered to reassess menopause symptoms, sleep, and quality of life. |
| Control Group | No intervention | –Arm Description: No intervention will be applied to participants in this group during the study period. A pre-test will be administered at the beginning and a post-test will be administered after 4 weeks to assess menopause symptoms, sleep quality, and quality of life. After the final test, laughter yoga will be practiced to prevent participant bias. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Being in the menopause period
- Having sufficient proficiency in understanding and expressing oneself in Turkish
- Agreeing to participate in the study
- Having physical and cognitive competence
- Not having a diagnosis of mental disorder
Key exclusion criteria (4 listed)
- Not participating in laughter yoga sessions
- Withdrawing from the study during the research phase
- Incomplete filling out of data collection forms
- Having contraindications for laughter yoga (Bleeding hemorrhoids, psychiatric disorders, epilepsy, undergoing surgery within the last 3 months, and similar conditions)
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 YogaAlso: Laughter TherapyThe intervention consists of a total of 8 laughter yoga sessions, with 2 sessions per week for four weeks. Each laughter yoga session is planned to last an average of 20 minutes. Each session will begin with clapping and warm-up exercises and continue with childlike games, deep breathing exercises, and laughter exercises. It will end with meditation. It is a group-based practice, and the aim is to increase psychosocial well-being by transforming fake laughter into real laughter and to benefit from the physiological effects of laughter. | Behavioural | Laughter Yoga Intervention Group |
Primary outcome
Change in Menopausal Symptoms
Time frame: Baseline and immediately after the 4-week intervention
Menopause symptoms will be assessed using the Menopause Rating Scale (MRS). Changes in total MRS scores from baseline to post-intervention will be compared between the intervention group and the control group.
2 secondary outcomes
Change in Sleep Quality
Time frame: Baseline and immediately after the 4-week intervention
Change in Menopause-Specific Quality of Life
Time frame: Baseline and immediately after the 4-week intervention
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 2 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in publications, including the analyzable data set, will be shared if the study results are published.
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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.
Prof. Dr. Gülten Güvenç, PhD contact
Prof.Dr. Gülten Güvenç, PhD principal investigator
Saglik Bilimleri Universitesi
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 Saglik Bilimleri Universitesi 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 6 inclusion and 4 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 2 Mar 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 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 Derya UZUNCA, BSc, RN (+905071720400, deryauzunca673@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Menopausal Symptoms (time frame: Baseline and immediately after the 4-week intervention). 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 2 Mar 2026.