NCT07526623

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

April 6, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 6, 2026

Last Update Submit

April 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Premenstrual Syndrome Scale

    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%.

    From enrollment to the end of treatment at 8 weeks

Study Arms (3)

Treatment 1

EXPERIMENTAL

Jacobson progressive Muscle Relaxation Tecnique

Other: Jacobson progressive muscle relaxation technique

Treatment 2

EXPERIMENTAL

Benson relaxation Technique

Other: Benson relaxation technique

Combine Treatment

EXPERIMENTAL

Combination of Jacobson progressive Muscle relaxation and Benson relaxation technique

Other: combine Jacobson progressive muscle relaxation and Benson relaxation technique

Interventions

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.

Treatment 2

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)

Treatment 1

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

Combine Treatment

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Not using contraceptive pills
  • Not attending sessions
  • To reduce PMS use another methods
  • Anemia, chronic health conditions, communication related disability
  • Any current pharmacologic or non-pharmacologic treatment of PMS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Lahore

Lahore, Punjab Province, 54000g, Pakistan

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • University of Health Sciences Lahore Lahore

    University of Health Sciences Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

April 7, 2026

Primary Completion (Estimated)

June 7, 2026

Study Completion (Estimated)

June 21, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations