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临床试验/CTRI/2021/11/037703
CTRI/2021/11/037703尚未招募不适用

Meditation and Yoga impact on Dysmenorrhea (MY ID Study)

DSTSATYAM9 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年9月11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
400
试验地点
9
主要终点
Pain

研究概览

简要总结

The proposed study is conducted in two phases. In the first phase, investigators will identify the prevalence of primary dysmenorrhea among the adolescent girls of the Udupi district. Two thaluks will be selected randomly from the Udupi district. From those two thaluks, the High schools and Pre-university colleges (both government and private) will be randomly selected as per the sample size calculation (≈5000 samples). The probability Proportionate Size (PPS) method will be adopted.

After obtaining permission from Principals and Headteachers of the High schools & Pre-university colleges, the assent will be sent to the parents along with the participant information sheet. Upon approval, the data will be collected on the prevalence of primary dysmenorrhea among adolescent girls by junior research fellow and field workers. Adolescent girls will be given the questionnaire on the prevalence of dysmenorrhea at the school level which will take 20 minutes of their time.

In Phase 2, the adolescent girls with high pain intensity (numerical pain rating scale ≥ 4) will be selected. The calculated sample size for the second phase of the study will be 200 in each group (treatment and control group). After obtaining assent from parents, data on the Numerical pain rating scale, Stress, Academic performance, perceived self-efficacy, and Bio-marker level will be assessed from both groups. Biomarkers (Hb, Prostaglandins, Estrogen & Progesterone) will be collected on the first day of the menstrual cycle, followed by a session of yoga and meditation conducted for a period of 45 minutes for 12 weeks. All the expenditures i.e., for yoga mat and biomarker study will be taken by the funding agency.  The intervention will be conducted at the school level,(as a cluster) during the school hours as per the slots allotted by the school administration.The intervention will take place 5 days a week and Sundays will be excluded. Yogaand Meditation intervention will not be performed for 3 days during menstruation as it can cause discomfort due to unbearable pain. They can continue with SOS medicine in case of unbearable pain.  Yogic intervention includes Loosening exercise, Asanas, Pranayama, Meditation, and Relaxation. These exercises will be introduced gradually, and adolescent girls will be performing the intervention for a duration of 45 minutes under the supervision of the investigator every day for 12 weeks. The students will do the yoga training under the supervision of the research team. After 12 weeks of intervention, the data will be collected by using the same tools as that of the pretest.  After the posttest assessment, the meditation and yoga intervention will be taught for the control group as well.


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
12.00 Year(s) 至 18.00 Year(s)(—)
性别
Female

入选标准

  • Based on simple random sampling, adolescent girls who are in the age group of 12-18 years of Udupi district are selected in phase
  • In phase 2 adolescent girls selected from phase 1 with a numerical pain rating scale score of more than 4 are subjected to Yoga and Meditation.

排除标准

  • Adolescent girls who are not willing to participate are excluded.

结局指标

主要结局

Pain

时间窗: Baseline (pretest assessment) | Post-test after 12 weeks of intervention

次要结局

  • Stress, Academic performance(Concentration and Absenteeism),Perceived Self-efficacy and Bio-markers(Hb,Progesterone,Estrogen,Prostaglandins)(Baseline (pretest assessment))

研究者

发起方
DSTSATYAM
申办方类型
Government funding agency

研究点 (9)

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