- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07526623
Combined Effect of Benson Relaxation Technique and Jacobson Progressive Muscle Relaxation Exercises on Premenstrual Syndrome
Combined Effect of Benson Relaxation and Jacobson Progressive Muscle Relaxation Techniques on Premenstrual Syndrome
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000g
- University of Health Sciences Lahore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Treatment 1
Jacobson progressive Muscle Relaxation Tecnique
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Jacobson PMR involves gradually contracting and relaxing the major 16 muscle group of human body from head to toe ( muscle include hands, arms, eye, eyebrows, neck, anterior neck, shoulder, back, chest, abdomen, buttocks, anterior thigh, posterior thigh, calves and feet)
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Experimental: Treatment 2
Benson relaxation Technique
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Benson Relaxation technique was presents in 1970 by Herbert Benson.
Benson Relaxation technique decrease the level of hormone catecholamine and also reduces the sympathetic nervous system which results in relaxation of muscle and also reducing anxiety and depression level in our body which results in promoting activities of daily life and build self- confidence.
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Experimental: Combine Treatment
Combination of Jacobson progressive Muscle relaxation and Benson relaxation technique
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Jacobson PMR involves gradually contracting and relaxing the major 16 muscle group of human body from head to toe ( muscle include hands, arms, eye, eyebrows, neck, anterior neck, shoulder, back, chest, abdomen, buttocks, anterior thigh, posterior thigh, calves and feet).
In Benson relaxation technique, participants will be placed in comfortable positions and will be asked to close their eyes and will focus on their breathing to remove disturbing thoughts from their mind and they will be asked to remind a word that bring peace to them such as God, love, rainbow etc.
While repeating the sedative words breathe deeply and regularly, inhale through nose and exhale through mouth.
At the same time they will be asked to relax their whole body muscle starting from tip of toes and continuing their upper body and the head muscles.
They will be asked not to think about any other thing and continue this exercise for 20 minutes and then open their eyes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Premenstrual Syndrome Scale
Time Frame: From enrollment to the end of treatment at 8 weeks
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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%.
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From enrollment to the end of treatment at 8 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: University of Health Sciences Lahore Lahore, University of Health Sciences Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHS/USERC-26/SEC/103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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