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临床试验/NCT07139223
NCT07139223已完成不适用

The Effect of Laughter Yoga on Premenstrual Syndrome Symptoms and Quality of Life in Young Women: A Randomized Controlled Trial

Lokman Hekim University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2025年10月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
69
试验地点
1
主要终点
Premenstrual Syndrome Symptom Severity

研究概览

简要总结

Premenstrual syndrome (PMS) is a common condition among young women, characterized by physical, emotional, and behavioral symptoms that negatively affect quality of life. Laughter yoga, a non-pharmacological mind-body intervention combining breathing techniques, relaxation, and intentional laughter, has been shown to reduce stress, improve mood, and enhance well-being. This randomized controlled trial aims to evaluate the effect of laughter yoga on PMS symptoms and quality of life in young women.

详细描述

The menstrual cycle is a physiological process that begins at puberty and continues until menopause. PMS is a recurrent condition that occurs in the luteal phase of the cycle and subsides with menstruation. It is associated with a wide range of psychological, physical, and behavioral symptoms, including irritability, depression, breast tenderness, bloating, sleep disturbances, and decreased academic or social functioning. These symptoms significantly impair daily activities and reduce quality of life, particularly in young women.

The prevalence of PMS varies across populations, but studies consistently indicate that approximately half of young women experience moderate to severe symptoms. In some cases, these symptoms result in absenteeism, reduced productivity, and academic difficulties. The most severe form, premenstrual dysphoric disorder (PMDD), affects a smaller proportion of women but has a profound impact on functioning.

Management of PMS includes both pharmacological and non-pharmacological interventions. Pharmacological treatments such as oral contraceptives, antidepressants, and hormonal therapies may provide relief but often cause side effects and are not always preferred by young women. Non-pharmacological approaches, including relaxation techniques, exercise, yoga, and complementary therapies, are increasingly considered due to their accessibility and fewer side effects.

Laughter yoga is a mind-body practice developed in the 1990s, combining breathing exercises, playful activities, and simulated laughter that soon turns into genuine laughter. The brain does not distinguish between spontaneous and voluntary laughter, and both can induce positive physiological and psychological effects. Research has shown that laughter yoga reduces stress, enhances immune function, increases endorphins, and promotes overall well-being. It is a simple, cost-effective, and sustainable intervention that can be applied individually or in groups.

Although laughter yoga has been studied in relation to stress reduction, mood enhancement, and chronic disease management, there is limited evidence regarding its specific effects on PMS. Preliminary findings suggest potential benefits in reducing PMS-related distress, but no randomized controlled trial has comprehensively examined its impact on both PMS symptoms and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Due to the nature of the intervention, participants and intervention providers cannot be blinded. However, the statistician performing the data analysis will remain blinded to group allocation. Data will be coded, and the statistician will analyze the outcomes without knowledge of whether participants belong to the intervention or control group.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Experiencing premenstrual symptoms (PMS score of 110 or higher),
  • Are between the ages of 18-25,
  • Have regular menstrual periods,
  • Can read and understand Turkish,

排除标准

  • Students who completed the pretest data collection forms incompletely,
  • Students who were taking medication due to a chronic illness,
  • Students who were using hormonal contraceptive methods,
  • Students who had any health problems that could create a communication barrier,
  • Students who were receiving medication for insomnia (such as SSRIs and SNRIs),
  • Students who were receiving treatment for PMS,
  • Students who were pregnant or lactating in the last 12 months,
  • Students who exercised regularly (affecting homogeneity between groups and intervention effectiveness),
  • Students who had a diagnosed psychiatric illness (depression, panic attacks, schizophrenia, etc.),
  • Students who had a condition that prevented them from practicing laughter yoga (abdominal surgery within the last three months, uncontrolled hypertension, glaucoma, hernia, epilepsy).

研究组 & 干预措施

intervention arm

Experimental

Intervention arm: Laughter yoga group sessions will be implemented twice a week for 4 weeks (8 sessions in total); the first session will be ~45 min, the subsequent sessions ~30 min. Sessions will be conducted face-to-face in a suitable room within the institution. Following the interim measurement in week 4, the intervention arm will continue structured individual laughter practices daily for 4 weeks.

干预措施: laughter yoga (Behavioral)

control arm

No Intervention

No intervention will be applied to the control arm; after the post-tests, the same training will be offered to this group for ethical reasons (delayed intervention).

结局指标

主要结局

Premenstrual Syndrome Symptom Severity

时间窗: 8 week

The Premenstrual Syndrome Scale (PMS) will be used to assess participants. Participants will first take a pre-intervention pretest. They will then complete a total of eight laughter yoga sessions twice a week for four weeks. Interim measurements will be taken after the laughter yoga sessions are completed. Participants will be assigned homework assignments to practice laughter practices daily for four weeks. Following the homework assignments, a post-test will be administered to assess changes in PMS symptom severity.

次要结局

未报告次要终点

研究者

发起方
Lokman Hekim University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gülsüm Akkuş

Lecturer

Lokman Hekim University

研究点 (1)

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