跳至主要内容
临床试验/CTRI/2025/04/085497
CTRI/2025/04/085497尚未招募不适用

Efficacy of Integrated Yoga on the symptoms of premenstrual syndrome, biomarkers, heart rate variability, quality of life and cognitive functions among female university students with premenstrual syndrome: a randomised controlled trial

Dr Kashinath G Metri1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
1) Biomarkers: Progesterone and Serotonin

研究概览

简要总结

Premenstrual syndrome (PMS) is a complex disorder characterized by periodic and recurring physical, psychological, emotional, and behavioral symptoms experienced by some females during their reproductive age. PMS significantly impairs quality of life, affecting personal relationships, academic performance, and professional efficiency, thereby highlighting its multifaceted burden on patients’ overall well-being. Evidence shows that yoga has numerous health benefits on female reproductive health, by facilitating hormonal regulation, improving blood circulation. Yoga increases vagal tone and thereby reducing stress, enhancing mood, cognitive function and emotional-mental health. Previous studies on the effects of yoga in managing premenstrual syndrome (PMS) have primarily focused on subjective assessments, such as symptom severity, quality of life, and related variables like pain. However, no research to date has incorporated objective measures, such as biomarkers, and heart rate variability which could enhance the robustness and reliability of the findings. In this study, we propose to evaluate the impact of a newly developed and validated yoga module specifically tailored to the four phases of the menstrual cycle (Menstrual, follicular, ovulation, and luteal phase). This module is designed to align with the natural hormonal dynamics and includes practices such as loosening exercises, yoga postures, bandhas, mudras, breathing techniques, relaxation, and meditation and assess its impact on progesterone and serotonin, heart rate variability, cognitive functions, symptoms of PMS, PMS related quality of life, mood states, pain, and quality of sleep. The intervention will be assessed among female university students experiencing PMS (as screened by "Premenstrual Syndrome Screening Tool") within the age range 18-30 years old. The experimental group will follow a 60 minutes module for 3 sessions per week 2 months. While, the control group will follow their usual routine. If successful, the study could position yoga as a low-cost, community-based intervention for managing premenstrual syndrome and its associated challenges, contributing to the growing field of mind-body research

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • Consenting female university students with PMS residing in the university hostels 2) Females within the age range 18-30 years 3) Must stay in university campus hostels.

排除标准

  • Females diagnosed with other gynecological disorders, physical or mental disorders, and menstrual irregularities 2) Females undergoing any long term medications 3) Females who are overweight or obese 4) Females with history of addiction or substance abuse 5) Females who has been exposed to yoga practices in the past 6 months 6) Females recieving any other mind-body therapies.

结局指标

主要结局

1) Biomarkers: Progesterone and Serotonin

时间窗: Baseline (0 week), post (after 8 weeks), and follow-up (after 12 weeks)

3) Symptoms of Premenstrual syndrome, Profiles of mood states, Premenstrual syndrome related quality of life

时间窗: Baseline (0 week), post (after 8 weeks), and follow-up (after 12 weeks)

2) Cognitive functions: sustained attention, working memory, and executive function (inhibitory control)

时间窗: Baseline (0 week), post (after 8 weeks), and follow-up (after 12 weeks)

次要结局

  • 1) Cardiac autonomic function: Heart rate variability(2) Sleep quality)

研究者

发起方
Dr Kashinath G Metri
申办方类型
Other [Self ]

研究点 (1)

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