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临床试验/NCT07526623
NCT07526623进行中(未招募)不适用

Combined Effect of Benson Relaxation and Jacobson Progressive Muscle Relaxation Techniques on Premenstrual Syndrome

University of Health Sciences Lahore1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年4月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
56
试验地点
1
主要终点
Premenstrual Syndrome Scale

研究概览

简要总结

Premenstrual syndrome is psycho-physiological stress induced condition including physical, behavioral, and psychological symptoms occur during luteal phase of menstrual cycle (after ovulation) and disappear within a few days after the onset of menstrual cycle .Bloating, breast tenderness, mood swings, food cravings, backache, headache, skin breakouts, depression, lack of energy, irritability, frequent urination, and insomnia are the symptoms of premenstrual syndrome. The aim of this study is to determine the combined effect of Benson relaxation and Jacobson progressive muscle relaxation techniques on Premenstrual syndrome. Three-arm parallel Randomized control trial (study design) in which three groups will be formed. A sample size of 56 female students will be selected from University of Health Sciences, Lahore using the purposive sampling technique and will be equally and randomly allocated to three groups using computer generated random number by Excel software. Jacobson PMR technique will be applied on group A and Benson Relaxation Technique on group B and both Benson relaxation and Jacobson progressive muscle relaxation techniques will be applied on group C for two months three times a week. Symptoms will be assessed before and at 8th week (at the end of treatment) by using the Premenstrual Syndrome Scale. There will be assessor blinding while data collecting in order to reduce biasness. The potential significance of combined effect of Benson relaxation technique and Jacobson progressive muscle relaxation is to reduce the symptoms of PMS, improving the quality of life, provide the non-pharmacological approach, improve daily functioning, provide the empowerment to women, enhance relationship, cost - effective, and it is assessable intervention that can be performed in various settings, and will provide the significant positive impact on the lives of women. Combined effect of Benson relaxation and Jacobson progressive muscle relaxation techniques will help in improving symptoms and provide mental and physical relaxation which will help women in enhancing self-control, in reducing absenteeism, improving productivity, increased sense of well- being, and increasing participation in social activities.

详细描述

Premenstrual syndrome is psycho-physiological stress induced condition including physical, behavioral, and psychological symptoms occur during luteal phase of menstrual cycle (after ovulation) and disappear within a few days after the onset of menstrual cycle. Bloating, breast tenderness, mood swings, food cravings, backache, headache, skin breakouts, depression, lack of energy, irritability, frequent urination, and insomnia are the symptoms of premenstrual syndrome. PMS has negative effect on quality of women's life and affect their social life, work-university and family relationships and their leisure activities . Physical activity help in increasing the levels of endorphins, which helps maintain the balance between progesterone and estrogens hormones and also stimulate the anti-inflammatory substances of the body .

Prevalence of PMS in different countries include India (65%), Iran (39.9%), Turkey (52.2%), and global prevalence ranging from (14.3%-74.4%0 and interpretation of PMS include: mild (45%), moderate (32.6%), severe (22.4%) calculated from the King Faisal University in Al Ahsa, Saudi Arabia. Despite the growing knowledge of research on PMS from (2020-2025), there remains a significant gap in literature according to specific intervention that exert their effect. Recent studies (2020-2025) have explored the various interventions and relaxation technique on PMS but there is no study on combined effect of Benson relaxation technique and JPMRT used. In various studies, there is a lack of intervention in control group that may exaggerated the effect of PMRE in experimental group . Further there no blinding of investigator which of might introduce bias in data collection and data analysis. Further there is no follow-up is taken after the application of initial treatment. Blinding procedures in study designs is important because it reduce bias and improve the reliability of results . Use of Combined effect of Benson relaxation technique and PMRT, implication of assessor blinding, and use of conservative treatment in control group in this study will fill the gap in previous studies. Combined effect of Benson relaxation and Jacobson progressive muscle relaxation techniques will help in improving PMS symptoms and provide mental and physical relaxation which will help women in enhancing self -control, improving relationships, in reducing absenteeism, improving productivity, increased sense of well- being, and increasing participation in social activities. The study will help in improving the quality of life, providing the non-pharmacological approach, improve daily functioning , providing the empowerment to women, enhancing relationship ,cost-effective, and it is assessable intervention that can be performed in various settings, and will provide the significant positive impact on the lives of women.

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)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between (18-30 years)
  • suffering from PMS
  • score of 45 or greater on PMSS
  • having regular menstrual cycle between 21- 35 days
  • not having a diagnosis of psychiatric problems
  • Not having gynecologic disease like abnormal uterine bleeding, ovarian cysts, uterine, fibroids etc.
  • Not having any health problem or underlying disease that prevent PMRT.

排除标准

  • Not using contraceptive pills
  • Not attending sessions
  • To reduce PMS use another methods
  • Withdrawing from the study voluntarily at any stage after inclusion
  • Anemia, chronic health conditions, communication related disability
  • Any current pharmacologic or non-pharmacologic treatment of PMS

研究组 & 干预措施

Treatment 2

Experimental

Benson relaxation Technique

干预措施: Benson relaxation technique (Other)

Treatment 1

Experimental

Jacobson progressive Muscle Relaxation Tecnique

干预措施: Jacobson progressive muscle relaxation technique (Other)

Combine Treatment

Experimental

Combination of Jacobson progressive Muscle relaxation and Benson relaxation technique

干预措施: combine Jacobson progressive muscle relaxation and Benson relaxation technique (Other)

结局指标

主要结局

Premenstrual Syndrome Scale

时间窗: From enrollment to the end of treatment at 8 weeks

Premenstrual Syndrome scale is a self-reporting scale was originally developed by comprise of 40 questions which is further divide into 3 subscales (Physiological, Psychological, and Behavioral symptoms). Ms. Padmavathi measured the inter-rater reliability of PMSS in 2013. In interrater reliability was reported between 0.81 and 0.97 and sensitivity ranges from 83-100% and specificity 64-90%.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayesha Abdul Hameed

Principal Investigator

University of Health Sciences Lahore

研究点 (1)

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