Premenstrual SyndromeNCT07074314
The Effect of Laughter Yoga and Premenstrual Symptoms
A study testing Laughter yoga in people with Premenstrual Syndrome and Quality of Life, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
Premenstrual Syndrome (PMS) describes somatic, cognitive, emotional, and behavioral symptoms that occur in women during the luteal phase of the menstrual cycle and resolve with the onset of menstruation. These symptoms are common during the reproductive years. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Quality of Life
- What is being tested?
- Laughter yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2025to 30 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the research
- Fully answering survey and scale forms
- Ability to read and understand Turkish
- Being between the ages of 18 and 25 years
- Having regular menstruation (between 21 and 35 days)
Who cannot join
- Unwilling to continue working
- Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
- Having a gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, hormonal treatment, etc.)
- Having a chronic or physical illness
- Having a mental illness
- Being under psychiatric treatment (Pharmacotherapy or psychotherapy)
- Taking medication for menopausal symptoms
- Using one of the pharmacological or non-pharmacological methods to reduce premenstrual symptoms (COCs, acupressure, homeopathy, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Laughter Yoga on Quality of Life and Premenstrual Symptoms in Young People With Premenstrual Syndrome: A Randomized Controlled Experimental Study
Premenstrual Syndrome (PMS) describes somatic, cognitive, emotional, and behavioral symptoms that occur in women during the luteal phase of the menstrual cycle and resolve with the onset of menstruation. These symptoms are common during the reproductive years. The emotional symptoms of PMS include depression, outbursts of anger, irritability, crying spells, anxiety, confusion, social withdrawal, poor concentration, insomnia, increased short sleep, and changes in sexual desire. Premenstrual symptoms negatively impact women's relationships with family, work, and friends, as well as their social activities. Furthermore, premenstrual symptoms negatively impact a woman's quality of life, making them an important issue to address early in a woman's life. Numerous treatment methods are used to reduce or eliminate PMS symptoms. Laughter yoga is one of the alternative medicine methods that has recently emerged and is used to maintain and improve health. No studies have examined the effectiveness of laughter yoga in reducing premenstrual syndrome. This study aims to determine the effects of laughter yoga on quality of life and premenstrual symptoms in young people experiencing premenstrual syndrome.
Read the detailed description
Premenstrual Syndrome (PMS) describes somatic, cognitive, emotional, and behavioral symptoms that occur in women during the luteal phase of the menstrual cycle and resolve with the onset of menstruation. These symptoms are common during the reproductive years. The emotional symptoms of PMS include depression, outbursts of anger, irritability, crying spells, anxiety, confusion, social withdrawal, poor concentration, insomnia, increased short sleep, and changes in sexual desire. Physical symptoms include thirst, appetite changes, breast tenderness, bloating and weight gain, headaches, swelling in the hands or feet, aches and pains, fatigue, skin problems, and gastrointestinal symptoms, which can occur in the days before and after menstruation. While the epidemiology, etiology, and pathophysiology of PMS, first described in the literature in 1931, have not yet been fully elucidated, factors that may contribute to its development include thyroid dysfunction, hormonal changes, neurotransmitters, hypoglycemia, fluid retention, genetic and psychological factors, diet, stress, and lifestyle. Epidemiological studies indicate that PMS affects approximately one-fifth of women. Therefore, while PMS is common in adolescence and young adulthood, it stands out as a significant problem during this period. Premenstrual symptoms negatively impact women's relationships with family, work, and friends, as well as their social activities. They can lead to losses in education and employment, decreased work productivity, increased error/accident rates, alcohol/substance abuse, and criminal behavior, and negative mother-child behavior. It's also known that mental disorders and physical illnesses worsen during the premenstrual period, and psychiatric hospitalizations increase. Furthermore, premenstrual symptoms negatively impact a woman's quality of life, making them an important issue to address early in a woman's life. Numerous treatment methods are used to reduce or eliminate PMS symptoms.
The goal of treatment for PMS is to reduce or eliminate symptoms, reduce negative impacts on activities and relationships, and minimize treatment side effects. A stepwise approach should be implemented in PMS treatment, encompassing non-pharmacological treatment, pharmacological treatment, and surgical treatment. It has been reported that 60% of women with PMS symptoms seek treatment for their symptoms, but only about half as often seek medical attention.
Recommended non-pharmacological treatments include lifestyle changes, education, dietary support, herbal treatment options, acupuncture, and cognitive behavioral therapy. Lifestyle changes include regular exercise, limiting caffeine, salt, and alcohol consumption, eliminating nicotine, and increasing complex carbohydrate intake. Exercise has been shown to reduce PMS symptoms. Shifting focus is particularly important. Cognitive therapy methods and physical activity have been found to reduce PMS symptoms. Alternative medicine methods, in particular, are widely used to reduce PMS symptoms.
Laughter yoga is one of the alternative medicine methods that has recently emerged and is used to maintain and improve health. Laughter is generally considered a visual expression of happiness or a feeling of joy. It also helps clarify one's intentions in social interactions and foster emotional connection in conversations. Laughter is contagious; when a person laughs, the person next to them is often moved and begins to laugh as well. Laughter has been described as a universal phenomenon that can be observed in the body and contributes to irreplaceable social functions. During the emergence of laughter, people establish relationships between objects and attribute specific meanings to them by comparing them with others. The combination of all these factors provides relief. People laugh not only at humor, but also when solving a puzzle, escaping a dangerous situation, winning a game, experiencing disappointment, feeling hopeless, encountering an old friend, feeling embarrassed, or angry. Laughter can occur in a variety of emotional states. Laughter yoga has been found to lower cortisol levels, stabilize blood pressure, and improve quality of life scores, especially after the fourth session. Laughter yoga has been found to have a positive impact on young people's overall health, improving physical well-being and symptoms of sleep disorders, reducing anxiety and depression scores, and improving social functioning. In this context, considering the uses and benefits of laughter yoga, it is thought that it may be effective in reducing PMS symptoms. There are numerous studies in the literature on premenstrual syndrome. However, few studies have investigated the effectiveness of alternative methods for reducing symptoms. No studies have examined the effectiveness of laughter yoga in reducing premenstrual syndrome. This study aims to determine the effects of laughter yoga on quality of life and premenstrual symptoms in young people experiencing premenstrual syndrome.
- Conditions
- Premenstrual Syndrome, Quality of Life
- Being tested
- Laughter yoga
- Keywords
- laughter yoga, premenstraul syndrome, qualifty 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 yogaOther
Part 1: Deep Breathing Exercises: Raise the arms up towards the sky and take a deep breath as possible and hold the breath for 4-5 seconds. This application is repeated several times. This section takes approximately 5-10 minutes.
Part 2: Warm-up exercises: Hands are kept parallel to each other and clapped. The tips of the fingers and palms touch each other, the acupuncture points on both hands are stimulated and the individual's energy level increases.
Section 3: Childish Games: In this section there are childish games. These games are visualized in the mind and the participants are asked to raise their arms upwards in the shape of the letter "Y".This section takes approximately 10 minutes.
Section 4: Laughter Exercises: Participants are given verbal guidance such as "Put your hand on your heart, feel your heartbeat, let's exhale with a smile, let's make a wish or pray" and the laughter exercise is terminated. This section takes approximately 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Laughter yoga group | Experimental | Before starting the intervention, the researcher attended a 12-hour "Laughter Yoga Leader" course (8 hours of theory and 4 hours of Laughter Yoga Practice). Following the course, the researcher received a "Laughter Yoga" certificate. In the first stage, all participants will be asked to introduce themselves by giving their names and places of birth. Then, laughter yoga will begin with warm-up exercises and hand clapping movements. In the second stage, deep breathing exercises will be performed. After the deep breathing exercises, in the third stage, childlike games will be used to help induce laughter. In the final stage, laughter exercises will be conducted. Laughter yoga sessions will be conducted twice a week for 8 weeks, for a total of 16 sessions. Each session will be 30 minutes in duration. Receives: Other: Laughter yoga |
| Control group | No intervention | Participants in this group will consist of people who do not routinely do any practice on their own to reduce stress and burnout levels. The researcher will ask the participants via phone 4 times a week for 1 month whether they have taken any action to reduce their stress and burnout symptoms. Participants who use any of the pharmacological or non-pharmacological practices to reduce stress and burnout symptoms will be excluded from the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Premenstrual Symptoms Coping Scale
This scale assesses the coping with premenstrual symptoms in women aged 18-49. The scale consists of 27 items and five subscales in Turkish. Each item on this five-point Likert-type scale is scored from one to five. The total score is not used.
Measured: between 2 to 4 weeks
Premenstrual Syndrome-Specific Quality of Life Scale
The scale consists of 22 items divided into three subscales: physical, emotional, and social. Reverse coding is used for all items, with a minimum score of 22 and a maximum score of 110.
Measured: between 2 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start25 Dec 2025
- Primary completion25 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Solt Kirca, Kırklareli University
- Investigators
- ELIF DAGLI, Phd, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074314
- Sponsor's protocol ID
- KırklareliAS-15
- Status last verified
- Jan 2026
- First submitted
- 10 Jul 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Quality of Life and Premenstrual Symptoms in Young People With Premenstrual Syndrome: A Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT07074314
- Acronym / sponsor ID
- KırklareliAS-15
- Conditions
- Premenstrual Syndrome, Quality of Life
- Keywords
- laughter yoga, premenstraul syndrome, qualifty of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 20 Jul 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) describes somatic, cognitive, emotional, and behavioral symptoms that occur in women during the luteal phase of the menstrual cycle and resolve with the onset of menstruation. These symptoms are common during the reproductive years. The emotional symptoms of PMS include depression, outbursts of anger, irritability, crying spells, anxiety, confusion, social withdrawal, poor concentration, insomnia, increased short sleep, and changes in sexual desire. Premenstrual symptoms negatively impact women's relationships with family, work, and friends, as well as their social activities. Furthermore, premenstrual symptoms negatively impact a woman's quality of life, making them an important issue to address early in a woman's life. Numerous treatment methods are used to reduce or eliminate PMS symptoms. Laughter yoga is one of the alternative medicine methods that has recently emerged and is used to maintain and improve health. No studies have examined the effectiveness of laughter yoga in reducing premenstrual syndrome. This study aims to determine the effects of laughter yoga on quality of life and premenstrual symptoms in young people experiencing premenstrual syndrome.
Detailed description
Premenstrual Syndrome (PMS) describes somatic, cognitive, emotional, and behavioral symptoms that occur in women during the luteal phase of the menstrual cycle and resolve with the onset of menstruation. These symptoms are common during the reproductive years. The emotional symptoms of PMS include depression, outbursts of anger, irritability, crying spells, anxiety, confusion, social withdrawal, poor concentration, insomnia, increased short sleep, and changes in sexual desire. Physical symptoms include thirst, appetite changes, breast tenderness, bloating and weight gain, headaches, swelling in the hands or feet, aches and pains, fatigue, skin problems, and gastrointestinal symptoms, which can occur in the days before and after menstruation. While the epidemiology, etiology, and pathophysiology of PMS, first described in the literature in 1931, have not yet been fully elucidated, factors that may contribute to its development include thyroid dysfunction, hormonal changes, neurotransmitters, hypoglycemia, fluid retention, genetic and psychological factors, diet, stress, and lifestyle. Epidemiological studies indicate that PMS affects approximately one-fifth of women. Therefore, while PMS is common in adolescence and young adulthood, it stands out as a significant problem during this period. Premenstrual symptoms negatively impact women's relationships with family, work, and friends, as well as their social activities. They can lead to losses in education and employment, decreased work productivity, increased error/accident rates, alcohol/substance abuse, and criminal behavior, and negative mother-child behavior. It's also known that mental disorders and physical illnesses worsen during the premenstrual period, and psychiatric hospitalizations increase. Furthermore, premenstrual symptoms negatively impact a woman's quality of life, making them an important issue to address early in a woman's life. Numerous treatment methods are used to reduce or eliminate PMS symptoms.
The goal of treatment for PMS is to reduce or eliminate symptoms, reduce negative impacts on activities and relationships, and minimize treatment side effects. A stepwise approach should be implemented in PMS treatment, encompassing non-pharmacological treatment, pharmacological treatment, and surgical treatment. It has been reported that 60% of women with PMS symptoms seek treatment for their symptoms, but only about half as often seek medical attention.
Recommended non-pharmacological treatments include lifestyle changes, education, dietary support, herbal treatment options, acupuncture, and cognitive behavioral therapy. Lifestyle changes include regular exercise, limiting caffeine, salt, and alcohol consumption, eliminating nicotine, and increasing complex carbohydrate intake. Exercise has been shown to reduce PMS symptoms. Shifting focus is particularly important. Cognitive therapy methods and physical activity have been found to reduce PMS symptoms. Alternative medicine methods, in particular, are widely used to reduce PMS symptoms.
Laughter yoga is one of the alternative medicine methods that has recently emerged and is used to maintain and improve health. Laughter is generally considered a visual expression of happiness or a feeling of joy. It also helps clarify one's intentions in social interactions and foster emotional connection in conversations. Laughter is contagious; when a person laughs, the person next to them is often moved and begins to laugh as well. Laughter has been described as a universal phenomenon that can be observed in the body and contributes to irreplaceable social functions. During the emergence of laughter, people establish relationships between objects and attribute specific meanings to them by comparing them with others. The combination of all these factors provides relief. People laugh not only at humor, but also when solving a puzzle, escaping a dangerous situation, winning a game, experiencing disappointment, feeling hopeless, encountering an old friend, feeling embarrassed, or angry. Laughter can occur in a variety of emotional states. Laughter yoga has been found to lower cortisol levels, stabilize blood pressure, and improve quality of life scores, especially after the fourth session. Laughter yoga has been found to have a positive impact on young people's overall health, improving physical well-being and symptoms of sleep disorders, reducing anxiety and depression scores, and improving social functioning. In this context, considering the uses and benefits of laughter yoga, it is thought that it may be effective in reducing PMS symptoms. There are numerous studies in the literature on premenstrual syndrome. However, few studies have investigated the effectiveness of alternative methods for reducing symptoms. No studies have examined the effectiveness of laughter yoga in reducing premenstrual syndrome. This study aims to determine the effects of laughter yoga on quality of life and premenstrual symptoms in young people experiencing premenstrual syndrome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Laughter yoga group | Experimental | Other: Laughter yogaBefore starting the intervention, the researcher attended a 12-hour "Laughter Yoga Leader" course (8 hours of theory and 4 hours of Laughter Yoga Practice). Following the course, the researcher received a "Laughter Yoga" certificate. In the first stage, all participants will be asked to introduce themselves by giving their names and places of birth. Then, laughter yoga will begin with warm-up exercises and hand clapping movements. In the second stage, deep breathing exercises will be performed. After the deep breathing exercises, in the third stage, childlike games will be used to help induce laughter. In the final stage, laughter exercises will be conducted. Laughter yoga sessions will be conducted twice a week for 8 weeks, for a total of 16 sessions. Each session will be 30 minutes in duration. |
| Control group | No intervention | –Participants in this group will consist of people who do not routinely do any practice on their own to reduce stress and burnout levels. The researcher will ask the participants via phone 4 times a week for 1 month whether they have taken any action to reduce their stress and burnout symptoms. Participants who use any of the pharmacological or non-pharmacological practices to reduce stress and burnout symptoms will be excluded from the study. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteering to participate in the research
- Fully answering survey and scale forms
- Ability to read and understand Turkish
- Being between the ages of 18 and 25 years
- Having regular menstruation (between 21 and 35 days)
Key exclusion criteria (8 listed)
- Unwilling to continue working
- Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
- Having a gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, hormonal treatment, etc.)
- Having a chronic or physical illness
- Having a mental illness
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 yogaPart 1: Deep Breathing Exercises: Raise the arms up towards the sky and take a deep breath as possible and hold the breath for 4-5 seconds. This application is repeated several times. This section takes approximately 5-10 minutes. Part 2: Warm-up exercises: Hands are kept parallel to each other and clapped. The tips of the fingers and palms touch each other, the acupuncture points on both hands are stimulated and the individual's energy level increases. Section 3: Childish Games: In this section there are childish games. These games are visualized in the mind and the participants are asked to raise their arms upwards in the shape of the letter "Y".This section takes approximately 10 minutes. Section 4: Laughter Exercises: Participants are given verbal guidance such as "Put your hand on your heart, feel your heartbeat, let's exhale with a smile, let's make a wish or pray" and the laughter exercise is terminated. This section takes approximately 15 minutes. | Other | Laughter yoga group |
Primary outcome
The Premenstrual Symptoms Coping Scale
Time frame: between 2 to 4 weeks
This scale assesses the coping with premenstrual symptoms in women aged 18-49. The scale consists of 27 items and five subscales in Turkish. Each item on this five-point Likert-type scale is scored from one to five. The total score is not used.
Premenstrual Syndrome-Specific Quality of Life Scale
Time frame: between 2 to 4 weeks
The scale consists of 22 items divided into three subscales: physical, emotional, and social. Reverse coding is used for all items, with a minimum score of 22 and a maximum score of 110.
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 27 Jan 2026.
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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.
ELIF DAGLI, Phd study director
Cukurova 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 and Quality of Life, run by Kırklareli 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 5 inclusion and 8 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 27 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?
The Premenstrual Symptoms Coping Scale (time frame: between 2 to 4 weeks). The study lists 2 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 27 Jan 2026.