- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07599436
Laughter Yoga and Sleep Hygiene Training for College Students With Premenstrual Syndrome (LYSHPMS)
14 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
45
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Ankara
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Ankara, Ankara, Turkiet (Türkiye), 06000
- Gazi University Institute of Health Sciences
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Participants were enrolled in a 4-week laughter yoga program.They received training on sleep hygiene
intervention group
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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.
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Inget ingripande: No interventions were made regarding the participants.
control grup
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes in premenstrual syndrome levels
Tidsram: Baseline, 4 weeks (end of intervention), 1-month follow-up
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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.
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Baseline, 4 weeks (end of intervention), 1-month follow-up
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes in perceived stress levels
Tidsram: Baseline, 4 weeks (end of intervention), 1-month follow-up
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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.
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Baseline, 4 weeks (end of intervention), 1-month follow-up
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Changes in sleep quality
Tidsram: Baseline, 4 weeks (end of intervention), 1-month follow-up
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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.
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Baseline, 4 weeks (end of intervention), 1-month follow-up
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Şengül YAMAN SÖZBİR, Gazi University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2026
Primärt slutförande (Faktisk)
1 maj 2026
Avslutad studie (Faktisk)
1 maj 2026
Studieregistreringsdatum
Först inskickad
4 maj 2026
Först inskickad som uppfyllde QC-kriterierna
14 maj 2026
Första postat (Faktisk)
20 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Sjukdomar i nervsystemet
- Mentala störningar
- Patologiska processer
- Vakna sömnstörningar
- Sömnstörningar, inneboende
- Dyssomni
- Menstruationsstörningar
- Patologiska tillstånd, tecken och symtom
- Beteende
- Hälsobeteende
- Sömninitiering och underhållsstörningar
- Premenstruellt syndrom
- Sömnhygien
- Terapeutik
- Patientvård
- Vårdtjänster
- Sjukvårdsanläggningar och tjänster
- Palliativ vård
Andra studie-ID-nummer
- EBS
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Data confidentiality and participant privacy will be strictly protected in accordance with applicable laws and regulations.
Individual participant data (IPD) will not be shared.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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