Premenstrual Syndrome-PMSNCT07139223
The Effect of Laughter Yoga on Premenstrual Syndrome Symptoms and Quality of Life in Young Women
A study testing laughter yoga in people with Premenstrual Syndrome-PMS, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
Premenstrual syndrome (PMS) is a common condition among young women, characterized by physical, emotional, and behavioral symptoms that negatively affect quality of life. Laughter yoga, a non-pharmacological mind-body intervention combining breathing techniques, relaxation, and intentional laughter, has been shown to… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Premenstrual Syndrome-PMS
- 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
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 15 Dec 2025
- 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 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Experiencing premenstrual symptoms (PMS score of 110 or higher),
- Are between the ages of 18-25,
- Have regular menstrual periods,
- Can read and understand Turkish,
Who cannot join
- Students who completed the pretest data collection forms incompletely,
- Students who were taking medication due to a chronic illness,
- Students who were using hormonal contraceptive methods,
- Students who had any health problems that could create a communication barrier,
- Students who were receiving medication for insomnia (such as SSRIs and SNRIs),
- Students who were receiving treatment for PMS,
Show all 10Show fewer
- Students who were pregnant or lactating in the last 12 months,
- Students who exercised regularly (affecting homogeneity between groups and intervention effectiveness),
- Students who had a diagnosed psychiatric illness (depression, panic attacks, schizophrenia, etc.),
- Students who had a condition that prevented them from practicing laughter yoga (abdominal surgery within the last three months, uncontrolled hypertension, glaucoma, hernia, epilepsy).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bilecik Seyh Edebali University
Bilecik, Bir Eyalet Seçin, 11000
About this study
Official title: The Effect of Laughter Yoga on Premenstrual Syndrome Symptoms and Quality of Life in Young Women: A Randomized Controlled Trial
Premenstrual syndrome (PMS) is a common condition among young women, characterized by physical, emotional, and behavioral symptoms that negatively affect quality of life. Laughter yoga, a non-pharmacological mind-body intervention combining breathing techniques, relaxation, and intentional laughter, has been shown to reduce stress, improve mood, and enhance well-being. This randomized controlled trial aims to evaluate the effect of laughter yoga on PMS symptoms and quality of life in young women.
Read the detailed description
The menstrual cycle is a physiological process that begins at puberty and continues until menopause. PMS is a recurrent condition that occurs in the luteal phase of the cycle and subsides with menstruation. It is associated with a wide range of psychological, physical, and behavioral symptoms, including irritability, depression, breast tenderness, bloating, sleep disturbances, and decreased academic or social functioning. These symptoms significantly impair daily activities and reduce quality of life, particularly in young women.
The prevalence of PMS varies across populations, but studies consistently indicate that approximately half of young women experience moderate to severe symptoms. In some cases, these symptoms result in absenteeism, reduced productivity, and academic difficulties. The most severe form, premenstrual dysphoric disorder (PMDD), affects a smaller proportion of women but has a profound impact on functioning.
Management of PMS includes both pharmacological and non-pharmacological interventions. Pharmacological treatments such as oral contraceptives, antidepressants, and hormonal therapies may provide relief but often cause side effects and are not always preferred by young women. Non-pharmacological approaches, including relaxation techniques, exercise, yoga, and complementary therapies, are increasingly considered due to their accessibility and fewer side effects.
Laughter yoga is a mind-body practice developed in the 1990s, combining breathing exercises, playful activities, and simulated laughter that soon turns into genuine laughter. The brain does not distinguish between spontaneous and voluntary laughter, and both can induce positive physiological and psychological effects. Research has shown that laughter yoga reduces stress, enhances immune function, increases endorphins, and promotes overall well-being. It is a simple, cost-effective, and sustainable intervention that can be applied individually or in groups.
Although laughter yoga has been studied in relation to stress reduction, mood enhancement, and chronic disease management, there is limited evidence regarding its specific effects on PMS. Preliminary findings suggest potential benefits in reducing PMS-related distress, but no randomized controlled trial has comprehensively examined its impact on both PMS symptoms and quality of life.
This randomized controlled trial is designed to address this gap. The intervention group will participate in structured laughter yoga sessions guided by a certified instructor, while the control group will receive no intervention during the study period. PMS symptom severity and quality of life will be assessed using validated scales at baseline, during the intervention, and at follow-up.
The study aims to provide scientific evidence on the effectiveness of laughter yoga as a non-pharmacological approach in PMS management. By evaluating both short-term and sustained effects, this trial seeks to contribute to women's health literature with an innovative, low-cost, and accessible intervention. The findings are expected to inform clinical practice and support the integration of laughter yoga into nursing and women's health care for improving symptom management and quality of life in young women.
- Conditions
- Premenstrual Syndrome-PMS
- Being tested
- laughter yoga
- Keywords
- Premenstrual Syndrome, Laughter Yoga, Quality of Life
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter yogaBehavioural
Intervention arm: Laughter yoga group sessions will be implemented twice a week for 4 weeks (8 sessions in total); the first session will be ~45 min, the subsequent sessions ~30 min. Sessions will be conducted face-to-face in a suitable room within the institution. Following the interim measurement in week 4, the intervention arm will continue structured individual laughter practices daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | Intervention arm: Laughter yoga group sessions will be implemented twice a week for 4 weeks (8 sessions in total); the first session will be ~45 min, the subsequent sessions ~30 min. Sessions will be conducted face-to-face in a suitable room within the institution. Following the interim measurement in week 4, the intervention arm will continue structured individual laughter practices daily for 4 weeks. Receives: Behavioral: laughter yoga |
| control arm | No intervention | No intervention will be applied to the control arm; after the post-tests, the same training will be offered to this group for ethical reasons (delayed intervention). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Symptom Severity
The Premenstrual Syndrome Scale (PMS) will be used to assess participants. Participants will first take a pre-intervention pretest. They will then complete a total of eight laughter yoga sessions twice a week for four weeks. Interim measurements will be taken after the laughter yoga sessions are completed. Participants will be assigned homework assignments to practice laughter practices daily for four weeks. Following the homework assignments, a post-test will be administered to assess changes in PMS symptom severity.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start15 Oct 2025
- Primary completion15 Nov 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual Syndrome-PMSStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a two-arm, randomized, parallel-group controlled trial with a 1:1 allocation ratio. Eligible participants will be randomly assigned to either the intervention group (laughter yoga sessions twice a week for 4 weeks, followed by 4 weeks of structured daily individual laughter practices) or the control group (no intervention during the study period). Assessments will be conducted at baseline, after the 4-week group sessions, and after the 8-week follow-up. The primary outcome is the change in PMS symptom severity, and the secondary outcome is the change in quality of life. Due to the nature of the intervention, participants and providers cannot be blinded; however, data will be coded and analyzed by a statistician blinded to group allocation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gülsüm Akkuş, Lokman Hekim University
- Investigators
- Didem ŞİMŞEK KÜÇÜKKELEPÇE, Study director, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139223
- Sponsor's protocol ID
- LokmanHekimU-KDH-GA-01
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Premenstrual Syndrome Symptoms and Quality of Life in Young Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07139223
- Acronym / sponsor ID
- LokmanHekimU-KDH-GA-01
- Conditions
- Premenstrual Syndrome-PMS
- Keywords
- Premenstrual Syndrome, Laughter Yoga, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 24 Aug 2025 (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.
Premenstrual syndrome (PMS) is a common condition among young women, characterized by physical, emotional, and behavioral symptoms that negatively affect quality of life. Laughter yoga, a non-pharmacological mind-body intervention combining breathing techniques, relaxation, and intentional laughter, has been shown to reduce stress, improve mood, and enhance well-being. This randomized controlled trial aims to evaluate the effect of laughter yoga on PMS symptoms and quality of life in young women.
Detailed description
The menstrual cycle is a physiological process that begins at puberty and continues until menopause. PMS is a recurrent condition that occurs in the luteal phase of the cycle and subsides with menstruation. It is associated with a wide range of psychological, physical, and behavioral symptoms, including irritability, depression, breast tenderness, bloating, sleep disturbances, and decreased academic or social functioning. These symptoms significantly impair daily activities and reduce quality of life, particularly in young women.
The prevalence of PMS varies across populations, but studies consistently indicate that approximately half of young women experience moderate to severe symptoms. In some cases, these symptoms result in absenteeism, reduced productivity, and academic difficulties. The most severe form, premenstrual dysphoric disorder (PMDD), affects a smaller proportion of women but has a profound impact on functioning.
Management of PMS includes both pharmacological and non-pharmacological interventions. Pharmacological treatments such as oral contraceptives, antidepressants, and hormonal therapies may provide relief but often cause side effects and are not always preferred by young women. Non-pharmacological approaches, including relaxation techniques, exercise, yoga, and complementary therapies, are increasingly considered due to their accessibility and fewer side effects.
Laughter yoga is a mind-body practice developed in the 1990s, combining breathing exercises, playful activities, and simulated laughter that soon turns into genuine laughter. The brain does not distinguish between spontaneous and voluntary laughter, and both can induce positive physiological and psychological effects. Research has shown that laughter yoga reduces stress, enhances immune function, increases endorphins, and promotes overall well-being. It is a simple, cost-effective, and sustainable intervention that can be applied individually or in groups.
Although laughter yoga has been studied in relation to stress reduction, mood enhancement, and chronic disease management, there is limited evidence regarding its specific effects on PMS. Preliminary findings suggest potential benefits in reducing PMS-related distress, but no randomized controlled trial has comprehensively examined its impact on both PMS symptoms and quality of life.
This randomized controlled trial is designed to address this gap. The intervention group will participate in structured laughter yoga sessions guided by a certified instructor, while the control group will receive no intervention during the study period. PMS symptom severity and quality of life will be assessed using validated scales at baseline, during the intervention, and at follow-up.
The study aims to provide scientific evidence on the effectiveness of laughter yoga as a non-pharmacological approach in PMS management. By evaluating both short-term and sustained effects, this trial seeks to contribute to women's health literature with an innovative, low-cost, and accessible intervention. The findings are expected to inform clinical practice and support the integration of laughter yoga into nursing and women's health care for improving symptom management and quality of life in young women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a two-arm, randomized, parallel-group controlled trial with a 1:1 allocation ratio. Eligible participants will be randomly assigned to either the intervention group (laughter yoga sessions twice a week for 4 weeks, followed by 4 weeks of structured daily individual laughter practices) or the control group (no intervention during the study period). Assessments will be conducted at baseline, after the 4-week group sessions, and after the 8-week follow-up. The primary outcome is the change in PMS symptom severity, and the secondary outcome is the change in quality of life. Due to the nature of the intervention, participants and providers cannot be blinded; however, data will be coded and analyzed by a statistician blinded to group allocation
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Behavioral: laughter yogaIntervention arm: Laughter yoga group sessions will be implemented twice a week for 4 weeks (8 sessions in total); the first session will be ~45 min, the subsequent sessions ~30 min. Sessions will be conducted face-to-face in a suitable room within the institution. Following the interim measurement in week 4, the intervention arm will continue structured individual laughter practices daily for 4 weeks. |
| control arm | No intervention | –No intervention will be applied to the control arm; after the post-tests, the same training will be offered to this group for ethical reasons (delayed intervention). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Experiencing premenstrual symptoms (PMS score of 110 or higher),
- Are between the ages of 18-25,
- Have regular menstrual periods,
- Can read and understand Turkish,
Key exclusion criteria (10 listed)
- Students who completed the pretest data collection forms incompletely,
- Students who were taking medication due to a chronic illness,
- Students who were using hormonal contraceptive methods,
- Students who had any health problems that could create a communication barrier,
- Students who were receiving medication for insomnia (such as SSRIs and SNRIs),
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 yogaIntervention arm: Laughter yoga group sessions will be implemented twice a week for 4 weeks (8 sessions in total); the first session will be ~45 min, the subsequent sessions ~30 min. Sessions will be conducted face-to-face in a suitable room within the institution. Following the interim measurement in week 4, the intervention arm will continue structured individual laughter practices daily for 4 weeks. | Behavioural | intervention arm |
Primary outcome
Premenstrual Syndrome Symptom Severity
Time frame: 8 week
The Premenstrual Syndrome Scale (PMS) will be used to assess participants. Participants will first take a pre-intervention pretest. They will then complete a total of eight laughter yoga sessions twice a week for four weeks. Interim measurements will be taken after the laughter yoga sessions are completed. Participants will be assigned homework assignments to practice laughter practices daily for four weeks. Following the homework assignments, a post-test will be administered to assess changes in PMS symptom severity.
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 Jan 2026.
- 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.
Didem ŞİMŞEK KÜÇÜKKELEPÇE study director
Lokman Hekim 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 Premenstrual Syndrome-PMS, run by Lokman Hekim 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 4 inclusion and 10 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 Jan 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?
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?
Premenstrual Syndrome Symptom Severity (time frame: 8 week). 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 Jan 2026.