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临床试验/CTRI/2024/09/073891
CTRI/2024/09/073891已完成不适用

Effectiveness of Yoga versus Relaxation Technique on symptoms and quality of life in Primary dysmenorrhea -A Randomized Control Trial.

Dr. APJ Abdul Kalam College of Physiotherapy1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年9月22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
70
试验地点
1
主要终点
(1) Quality of life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-QSF)

研究概览

简要总结

. Procedure-

 Protocol is prepared and ethical clearance will be obtained from the IEC and after CTRI registration.

All the participants will be included according to the inclusion and exclusion criteria. The informed written consent and demographic data will be taken from participants regarding the procedure prior to the study and 70 participants with age between 19years to 25 years will be included in study.

 Detailed history will be obtained and pre-assessment for primary dysmenorrhea will be carried out for all the participants for symptoms of primary dysmenorrhea by Premenstrual syndrome questionnaire (PMSQ) and quality of life will be assessed by Quality of life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF).

 The participants will be divided in 2 groups where group A (35 participants) will undergo Yoga and group B (35 participants) will receive Jacobson relaxation technique. All the groups will undergo physical activities mentioned during their menstruation period for 5 days two session a day with adequate rest period. The duration of each session will be 20 minutes. The study will be continued for about for about 2 months. Participants will be reassessed for their symptoms using Premenstrual syndrome questionnaire (PMSQ) and Quality of life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
19.00 Year(s) 至 25.00 Year(s)(—)
性别
Female

入选标准

  • (1) Participants within age group of 19years.
  • 25years (2) Participants with positive symptoms of Primary Dysmenorrhea (3) Participants willing to participate in this study. (4) Participants who are non-athlete (5) Participants with no history of severe mental or physical condition (6) Participants with no history of joint motion, muscle and bone disease that reduces the ability to perform exercise. (7) Participants having regular menstrual cycle.

排除标准

  • (1) Participants with known pelvic pathology.
  • (2) Participants under medication (3) Participants who are not willing to participate (4) Participants under going regular exercise.
  • (5) Participants who are not able to tolerate physical exercise (6) Participant who have undergone recent surgery.(7) Participants with chronic disease such as diabetes, hypertension, cardiac disease, infectious disease, reproductive system disease.
  • (8) Participants who are pregnant (9) Participants who have undergone gynecological surgery (10) Participants who are athlete.

结局指标

主要结局

(1) Quality of life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-QSF)

时间窗: week 0 and week 8

(2) Premenstrual Syndrome Questionnaire (PMSQ)

时间窗: week 0 and week 8

次要结局

  • (1) Quality of life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-QSF)

研究者

发起方
Dr. APJ Abdul Kalam College of Physiotherapy
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Palak Nisar

Pravara Institute of Medical Sciences

研究点 (1)

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