Laughter YogaLYSHPMSNCT07599436
Laughter Yoga and Sleep Hygiene Training for College Students With Premenstrual Syndrome
A study testing Supportive Care in people with Laughter Yoga and Premenstrual Syndrome-PMS, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of laughter yoga and sleep hygiene training on premenstrual syndrome (PMS) symptoms, perceived stress levels, and sleep quality among nursing students.Premenstrual syndrome is a common health issue characterized by physical symptoms as well as emotional fluctuations, anxiety… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laughter Yoga, Premenstrual Syndrome-PMS, Stress
- What is being tested?
- Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 May 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, 18 years of age or older
- Second-year nursing student (who has not yet taken the Women's Health and Diseases Nursing course)
- Having a regular menstrual cycle
- Scoring 45 or higher on the Premenstrual Syndrome Scale (PMS level is mild)
- Using the WhatsApp® app
Who cannot join
- Having any communication difficulties (mental, auditory, visual, etc.)
- Having previously participated in a stress management program
- Using pharmacological or non-pharmacological methods to manage PMS symptoms
- Having a chronic or neuropsychiatric condition
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Institute of Health Sciences
Ankara, Ankara, 06000
About this study
Official title: The Effect of Laughter Yoga and Sleep Hygiene Training on Premenstrual Syndrome Levels, Perceived Stress Levels, and Sleep Quality Among University Students
This study aims to evaluate the effects of laughter yoga and sleep hygiene training on premenstrual syndrome (PMS) symptoms, perceived stress levels, and sleep quality among nursing students.Premenstrual syndrome is a common health issue characterized by physical symptoms as well as emotional fluctuations, anxiety, depressive mood, and behavioral changes, which can negatively impact quality of life. Additionally, it is known that stress is a significant risk factor that exacerbates PMS symptoms, and that healthy lifestyle behaviors may be effective in alleviating these symptoms. In this context, it has been reported that yoga and similar relaxation-based practices support mental well-being by reducing stress levels.The intervention consists of laughter yoga and sleep hygiene education, implemented as non-pharmacological methods over a 4-week period.Participants were assessed at baseline, immediately following the intervention, and during the 1-month follow-up period. The primary objective is to observe improved sleep quality alongside reductions in PMS symptoms and stress levels in participants as a result of the intervention. The findings are expected to contribute to the effectiveness of non-pharmacological, low-cost, and feasible approaches in managing PMS symptoms, as well as addressing stress and sleep quality.
Read the detailed description
Premenstrual syndrome (PMS) is a common health issue characterized by emotional fluctuations, anxiety, depressive mood, and behavioral changes, in addition to physical symptoms that can negatively impact quality of life. PMS can lead to a decline in quality of life by negatively affecting an individual's social life, psychological well-being, emotional balance, and dietary habits; in some individuals, it can develop into a severe condition that significantly restricts daily life. Within the multifaceted nature of PMS, stress emerges as a significant risk factor; it is noted that stress can increase symptom severity, elevate the frequency of traumatic life experiences, and underlie sleep disturbances in individuals. Deterioration in sleep quality further exacerbates this process, being associated with fatigue, emotional fluctuations, and a decline in overall well-being. While non-pharmacological methods are used to mitigate or prevent these effects on the individual, laughter yoga-based interventions remain limited. This study evaluates laughter yoga-a low-cost, feasible non-pharmacological method that incorporates simulated laughter, rhythmic breathing, gentle movements, and meditation-examining its effects on PMS management, stress-related hormone (cortisol) levels, and sleep quality.The intervention consisted of laughter yoga and sleep hygiene training administered over a 4-week period. Sleep hygiene training was provided during the first session of laughter yoga. Participants were assessed at different time points: at baseline, immediately following the intervention, and at the 1-month follow-up. The primary objective of the study is to assess changes in PMS levels, stress, and sleep quality over time among university students and to determine the sustainability of the intervention's effects during the follow-up period. This study contributes to the literature on nonpharmacological methods used to evaluate the effectiveness of interventions on PMS levels, stress, and sleep quality.
- Conditions
- Laughter Yoga, Premenstrual Syndrome-PMS, Stress, Sleep Quality
- Being tested
- Supportive Care
- Keywords
- Laughter Yoga, Premenstrual Syndrome, Stress, Nursing Students, Non-pharmacological method, Sleep Hygiene
- Medical subject headings
- Premenstrual Syndrome, Sleep Initiation and Maintenance Disorders, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive CareBehavioural
University students participated in 45-minute laughter yoga sessions held once a week for four weeks. During the first session, participants received training on sleep hygiene and were given a brochure on the topic. The sleep hygiene training covered the following topics: sleep, the importance of sleep, factors affecting sleep (circadian rhythm, sleep-wake cycle, nutrition, physical activity), factors causing poor sleep, sleep deprivation, and sleep hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Participants were enrolled in a 4-week laughter yoga program.They received training on sleep hygiene | Experimental | intervention group Receives: Behavioral: Supportive Care |
| No interventions were made regarding the participants. | No intervention | control grup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in premenstrual syndrome levels
PMS levels and associated physical, emotional, and behavioral changes in participants were measured using a validated scale. Changes in PMS levels were assessed by comparing the intervention and control groups.The Premenstrual Syndrome Scale (PSS) was used to evaluate the data.The scale consists of a total of 44 items and 9 subscales, organized on a 5-point Likert scale. The scale is scored as follows: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, and 5 = always. Scores obtained from the scale can be calculated separately for each subscale or evaluated based on the total score. The total scale score ranges from 44 to 220, and the presence of PMS is considered in individuals scoring 132 or higher. Additionally, the severity of PMS is classified as follows: 44 points = no PMS, 45-103 points = mild PMS, 104-163 points = moderate PMS, and 164-220 points = severe PMS.
Measured: Baseline, 4 weeks (end of intervention), 1-month follow-up
Secondary outcomes (2)
Changes in perceived stress levels
Participants' perceived stress levels were measured using a validated scale. Changes in stress levels were assessed by comparing the intervention and control groups. The Perceived Stress Scale (PSS) was used to analyze the data.The scale consists of a total of 14 items, each of which is rated on a 5-point Likert scale (0 = Never, 4 = Very often). The scale consists of two subscales: low self-efficacy perception (items 4, 5, 6, 8, 9, 10, 13) and stress/distress perception (items 1, 2, 3, 7, 11, 12, 14). Items 4, 5, 6, 7, 9, 10, and 13 are reverse-scored. The lowest and highest possible scores a participant can achieve on this scale are 0 and 56, respectively. An increase in the total score from the scale or its subscales indicates an increase in the individual's perceived stress level.
Measured: Baseline, 4 weeks (end of intervention), 1-month follow-up
Changes in sleep quality
Participants' sleep quality was measured using a validated scale. Changes in sleep quality were assessed by comparing the intervention and control groups. The assessment was conducted using the Pittsburgh Sleep Quality Index (PSQI). The scale consists of 24 questions. The first 18 questions, which the participant answers themselves, are used to calculate the total score and the subscale scores. The 18 questions on the scale cover 7 components: sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disorder (component 5), sleep medication use (component 6), and daytime sleep dysfunction (component 7). Each component is scored on a scale of 0-3. The sum of these 7 component scores yields the total score. The total score ranges from 0 to 21. Individuals with a score of 5 or below are assessed as having "good" sleep quality, while those with a score above 5 are assessed as having "poor" sleep quality.
Measured: Baseline, 4 weeks (end of intervention), 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Mar 2026
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laughter YogaStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Model description
- Participants underwent a 4-week program of laughter yoga, a non-pharmacological method. Sleep hygiene education was provided during the first session. Baseline, post-intervention, and 1-month follow-up assessments were conducted.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şengül Yaman Sözbir, Gazi University
- Investigators
- Şengül YAMAN SÖZBİR, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599436
- Sponsor's protocol ID
- EBS
- Acronym
- LYSHPMS
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data confidentiality and participant privacy will be strictly protected in accordance with applicable laws and regulations. Individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga and Sleep Hygiene Training on Premenstrual Syndrome Levels, Perceived Stress Levels, and Sleep Quality Among University Students
- ClinicalTrials.gov ID
- NCT07599436
- Acronym / sponsor ID
- LYSHPMS / EBS
- Conditions
- Laughter Yoga, Premenstrual Syndrome-PMS, Stress, Sleep Quality
- Keywords
- Laughter Yoga, Premenstrual Syndrome, Stress, Nursing Students, Non-pharmacological method, Sleep Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 20 May 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 evaluate the effects of laughter yoga and sleep hygiene training on premenstrual syndrome (PMS) symptoms, perceived stress levels, and sleep quality among nursing students.Premenstrual syndrome is a common health issue characterized by physical symptoms as well as emotional fluctuations, anxiety, depressive mood, and behavioral changes, which can negatively impact quality of life. Additionally, it is known that stress is a significant risk factor that exacerbates PMS symptoms, and that healthy lifestyle behaviors may be effective in alleviating these symptoms. In this context, it has been reported that yoga and similar relaxation-based practices support mental well-being by reducing stress levels.The intervention consists of laughter yoga and sleep hygiene education, implemented as non-pharmacological methods over a 4-week period.Participants were assessed at baseline, immediately following the intervention, and during the 1-month follow-up period. The primary objective is to observe improved sleep quality alongside reductions in PMS symptoms and stress levels in participants as a result of the intervention. The findings are expected to contribute to the effectiveness of non-pharmacological, low-cost, and feasible approaches in managing PMS symptoms, as well as addressing stress and sleep quality.
Detailed description
Premenstrual syndrome (PMS) is a common health issue characterized by emotional fluctuations, anxiety, depressive mood, and behavioral changes, in addition to physical symptoms that can negatively impact quality of life. PMS can lead to a decline in quality of life by negatively affecting an individual's social life, psychological well-being, emotional balance, and dietary habits; in some individuals, it can develop into a severe condition that significantly restricts daily life. Within the multifaceted nature of PMS, stress emerges as a significant risk factor; it is noted that stress can increase symptom severity, elevate the frequency of traumatic life experiences, and underlie sleep disturbances in individuals. Deterioration in sleep quality further exacerbates this process, being associated with fatigue, emotional fluctuations, and a decline in overall well-being. While non-pharmacological methods are used to mitigate or prevent these effects on the individual, laughter yoga-based interventions remain limited. This study evaluates laughter yoga-a low-cost, feasible non-pharmacological method that incorporates simulated laughter, rhythmic breathing, gentle movements, and meditation-examining its effects on PMS management, stress-related hormone (cortisol) levels, and sleep quality.The intervention consisted of laughter yoga and sleep hygiene training administered over a 4-week period. Sleep hygiene training was provided during the first session of laughter yoga. Participants were assessed at different time points: at baseline, immediately following the intervention, and at the 1-month follow-up. The primary objective of the study is to assess changes in PMS levels, stress, and sleep quality over time among university students and to determine the sustainability of the intervention's effects during the follow-up period. This study contributes to the literature on nonpharmacological methods used to evaluate the effectiveness of interventions on PMS levels, stress, and sleep quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants underwent a 4-week program of laughter yoga, a non-pharmacological method. Sleep hygiene education was provided during the first session. Baseline, post-intervention, and 1-month follow-up assessments were conducted.
| Arm | Type | Receives |
|---|---|---|
| Participants were enrolled in a 4-week laughter yoga program.They received training on sleep hygiene | Experimental | Behavioral: Supportive Careintervention group |
| No interventions were made regarding the participants. | No intervention | –control grup |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female, 18 years of age or older
- Second-year nursing student (who has not yet taken the Women's Health and Diseases Nursing course)
- Having a regular menstrual cycle
- Scoring 45 or higher on the Premenstrual Syndrome Scale (PMS level is mild)
- Using the WhatsApp® app
Key exclusion criteria (4 listed)
- Having any communication difficulties (mental, auditory, visual, etc.)
- Having previously participated in a stress management program
- Using pharmacological or non-pharmacological methods to manage PMS symptoms
- Having a chronic or neuropsychiatric condition
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 |
|---|---|---|
| Supportive CareUniversity students participated in 45-minute laughter yoga sessions held once a week for four weeks. During the first session, participants received training on sleep hygiene and were given a brochure on the topic. The sleep hygiene training covered the following topics: sleep, the importance of sleep, factors affecting sleep (circadian rhythm, sleep-wake cycle, nutrition, physical activity), factors causing poor sleep, sleep deprivation, and sleep hygiene. | Behavioural | Participants were enrolled in a 4-week laughter yoga program.They received training on sleep hygiene |
Primary outcome
Changes in premenstrual syndrome levels
Time frame: Baseline, 4 weeks (end of intervention), 1-month follow-up
PMS levels and associated physical, emotional, and behavioral changes in participants were measured using a validated scale. Changes in PMS levels were assessed by comparing the intervention and control groups.The Premenstrual Syndrome Scale (PSS) was used to evaluate the data.The scale consists of a total of 44 items and 9 subscales, organized on a 5-point Likert scale. The scale is scored as follows: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, and 5 = always. Scores obtained from the scale can be calculated separately for each subscale or evaluated based on the total score. The total scale score ranges from 44 to 220, and the presence of PMS is considered in individuals scoring 132 or higher. Additionally, the severity of PMS is classified as follows: 44 points = no PMS, 45-103 points = mild PMS, 104-163 points = moderate PMS, and 164-220 points = severe PMS.
2 secondary outcomes
Changes in perceived stress levels
Time frame: Baseline, 4 weeks (end of intervention), 1-month follow-up
Changes in sleep quality
Time frame: Baseline, 4 weeks (end of intervention), 1-month follow-up
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 20 May 2026.
- Individual participant dataSharing planned: No. Data confidentiality and participant privacy will be strictly protected in accordance with applicable laws and regulations. Individual participant data (IPD) will not be shared.
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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.
Şengül YAMAN SÖZBİR principal investigator
Gazi 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 Supportive Care in people with Laughter Yoga and Premenstrual Syndrome-PMS, run by Gazi 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 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: finished, as of the sponsor's last update on 20 May 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?
Changes in premenstrual syndrome levels (time frame: Baseline, 4 weeks (end of intervention), 1-month follow-up). 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 20 May 2026.