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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laughter Yoga | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and immediately after the 4-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and immediately after the 4-week intervention |
| Change in Menopause-Specific Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Derya UZUNCA, BSc, RN | Contact | +905071720400 | deryauzunca673@gmail.com | |
| Prof. Dr. Gülten Güvenç, PhD | Contact | gulten.guvenc@sbu.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Prof.Dr. Gülten Güvenç, PhD | Saglik Bilimleri Universitesi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mamak Aile Merkezleri | Ankara | Ankara | 06260 | Turkey (Türkiye) |
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.
Beginning 6 months after publication (if published) and available for up to 5 years upon reasonable request.
Access to de-identified individual participant data (IPD), the study protocol, and the statistical analysis plan will be granted to qualified researchers who provide a methodologically sound proposal. Requests must be submitted to the corresponding investigator via institutional email. Data will be shared in a de-identified format after approval of the proposal and completion of a data use agreement to ensure protection of participant confidentiality.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D027641 | Laughter Therapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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.
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Participants will not know which group they belong to. Laughter yoga will be administered to the experimental group on the day of the final test. By having both groups receive laughter yoga, participants will be prevented from knowing which group they belong to, thereby reducing the possibility of bias.
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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. |
| Baseline and immediately after the 4-week intervention |
| D001523 |
| Mental Disorders |