- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07599436
Laughter Yoga and Sleep Hygiene Training for College Students With Premenstrual Syndrome (LYSHPMS)
May 14, 2026 updated by: Şengül Yaman Sözbir, Gazi University
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ankara
-
Ankara, Ankara, Turkey (Türkiye), 06000
- Gazi University Institute of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria for the study:
- 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
Exclusion criteria for the study:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants were enrolled in a 4-week laughter yoga program.They received training on sleep hygiene
intervention group
|
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.
|
|
No Intervention: No interventions were made regarding the participants.
control grup
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 4 weeks (end of intervention), 1-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in perceived stress levels
Time Frame: Baseline, 4 weeks (end of intervention), 1-month follow-up
|
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.
|
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
|
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.
|
Baseline, 4 weeks (end of intervention), 1-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Şengül YAMAN SÖZBİR, Gazi University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2026
Primary Completion (Actual)
May 1, 2026
Study Completion (Actual)
May 1, 2026
Study Registration Dates
First Submitted
May 4, 2026
First Submitted That Met QC Criteria
May 14, 2026
First Posted (Actual)
May 20, 2026
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 14, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Mental Disorders
- Pathologic Processes
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Menstruation Disturbances
- Pathological Conditions, Signs and Symptoms
- Behavior
- Health Behavior
- Sleep Initiation and Maintenance Disorders
- Premenstrual Syndrome
- Sleep Hygiene
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Palliative Care
Other Study ID Numbers
- EBS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data confidentiality and participant privacy will be strictly protected in accordance with applicable laws and regulations.
Individual participant data (IPD) will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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