NCT07599436

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 4, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

Laughter YogaPremenstrual SyndromeStressNursing StudentsNon-pharmacological methodSleep Hygiene

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 4 weeks (end of intervention), 1-month follow-up

Secondary Outcomes (2)

  • Changes in perceived stress levels

    Baseline, 4 weeks (end of intervention), 1-month follow-up

  • Changes in sleep quality

    Baseline, 4 weeks (end of intervention), 1-month follow-up

Study Arms (2)

Participants were enrolled in a 4-week laughter yoga program.They received training on sleep hygiene

EXPERIMENTAL

intervention group

Behavioral: Supportive Care

No interventions were made regarding the participants.

NO INTERVENTION

control grup

Interventions

Supportive CareBEHAVIORAL

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.

Participants were enrolled in a 4-week laughter yoga program.They received training on sleep hygiene

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Institute of Health Sciences

Ankara, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual SyndromeSleep Initiation and Maintenance DisordersSleep Hygiene

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Şengül YAMAN SÖZBİR

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study with no masking
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 20, 2026

Study Start

March 1, 2026

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Data confidentiality and participant privacy will be strictly protected in accordance with applicable laws and regulations. Individual participant data (IPD) will not be shared.

Locations