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Laughter Yoga and Sleep Hygiene Training for College Students With Premenstrual Syndrome (LYSHPMS)

14. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

45

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Turecko (Türkiye)
    • Ankara
      • Ankara, Ankara, Turecko (Türkiye), 06000
        • Gazi University Institute of Health Sciences

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Participants were enrolled in a 4-week laughter yoga program.They received training on sleep hygiene
intervention group
Behaviorální: Supportive Care
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.
Žádný zásah: No interventions were made regarding the participants.
control grup

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in premenstrual syndrome levels
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in perceived stress levels
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Gazi University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Şengül YAMAN SÖZBİR, Gazi University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. března 2026

Primární dokončení (Aktuální)

1. května 2026

Dokončení studie (Aktuální)

1. května 2026

Termíny zápisu do studia

První předloženo

4. května 2026

První předloženo, které splnilo kritéria kontroly kvality

14. května 2026

První zveřejněno (Aktuální)

20. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • EBS

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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