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临床试验/CTRI/2025/07/090072
CTRI/2025/07/090072已完成不适用

Effect of Yogic Intervention on Dysmenorrhea among Adolescent Girls.

Meenakshi Saraf1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
1
主要终点
Progesterone level ,Pain Severity

研究概览

简要总结

This study is a randomized, parallel-group, controlled trial designed to assess the effectiveness of a 90-day structured yogic intervention on dysmenorrhea among adolescent school-going girls aged 13–19 years. The trial was conducted at Government Girls Inter College (GGIC), Srinagar, Garhwal, Uttarakhand, India.

The initially calculated sample size was 82 participants, determined using G*Power analysis with a 20% anticipated dropout rate. However, due to limited parental consent, a total of 70 participants meeting the inclusion criteria (mild to severe dysmenorrhea; Verbal Multidimensional Scoring System [VMSS] score 1–3) were enrolled in the study. Participants were randomly assigned into two groups: Experimental group (n=35) and Control group (n=35).

The experimental group underwent daily 60-minute structured yogic sessions for 90 consecutive days, while the control group continues their routine activities without intervention.

The primary outcome measures include serum progesterone levels (assessed through venous blood sampling and analyzed at an authorized pathology laboratory) and severity of dysmenorrhea measured using the Verbal Multidimensional Scoring System (VMSS). Serum progesterone levels were evaluated at baseline and post-intervention, whereas VMSS scores are assessed at baseline, post-intervention, and one-month follow-up.

Secondary outcome measures included depression (assessed using the Mental Depression Scale) and emotional maturity (assessed using the Emotional Maturity Scale), measured at baseline, post-intervention, and one-month follow-up.

The study aimed to evaluate yoga as a holistic, non-pharmacological intervention for managing both physiological and psychological symptoms associated with dysmenorrhea among adolescents.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
13.00 Year(s) 至 19.00 Year(s)(—)
性别
Female

入选标准

  • This study will include Adolescent students having mild, moderate and severe menstrual pain.
  • Students between the ages of 13- 19 years.
  • Only school-going girls will be included.
  • Girls participating willingly will be included.

排除标准

  • Adolescent girls having any kind of health complication and undergoing medication.
  • Physiological and psychological complications.
  • Married females will not be included.

结局指标

主要结局

Progesterone level ,Pain Severity

时间窗: At baseline (pre-intervention) and at the end of 12 weeks (post-intervention)

次要结局

  • Emotional Maturity(At baseline (pre-intervention), at the end of 12 weeks (post-intervention), & at 16 weeks (1-month follow-up).)
  • Depression(At baseline (pre-intervention), at the end of 12 weeks (post-intervention), & at 16 weeks (1-month follow-up).)

研究者

发起方
Meenakshi Saraf
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Meenakshi Saraf

Hemvati Nandan Bahuguna Garhwal University (A Central University)

研究点 (1)

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