NCT07628452

Brief Summary

The study will focus on the comparative effects of aerobic exercises and Jacobson's progressive relaxation technique on pain, fatigue and quality of life in primary dysmenorrhea. This study will be a randomized clinical trial and will be conducted in, Superior college depalpur and Army public schools and college Lahore (APSACS). Non probability convenience sampling will be used to collect the data.64 participants will be selected on the basis of inclusion and exclusion criteria and will be equally divided into two groups by sealed opaque enveloped .Participants having age group between 17-24 years and diagnosed with WaLiDD score are included.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

October 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

aerobic exercisequality of life,dysmenorrhea,female,Jacobson's progressive relaxation technique

Outcome Measures

Primary Outcomes (3)

  • WaLlDD relaxation technique on pain, fatigue and quality of life in primary dysmenorrhea.

    At baseline, the participant scored at the initial level on the WaLliDD scale, indicating their starting status. Over time, changes in the score reflect improvement or decline in the measured outcome. An increase in score suggests positive progress in the targeted domain, while a decrease indicates reduced functioning or worsening condition compared to baseline.

    2 months

  • Fatigue Assessment Scale

    At baseline, the participant's fatigue level is measured using the Fatigue Assessment Scale, providing a starting score of perceived fatigue. Changes in the score over time indicate variation in fatigue severity. A decrease from baseline reflects improvement (reduced fatigue), while an increase indicates worsening fatigue compared to the initial assessment.

    2 months

  • EQ-5D-5-L-Questionnaire

    The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life. It measures five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels of severity. It also includes a visual analog scale (VAS) where individuals rate their overall health. Higher scores indicate better perceived health status.

    2 months

Study Arms (2)

aerobic exercises

ACTIVE COMPARATOR

Group A will receive aerobic exercises for 3 times in a week.

Other: aerobic exercises

Jacobson's progressive relaxation technique

EXPERIMENTAL

Group B will receive Jacobson\'s progressive relaxation technique for 3 times in a week.

Other: Jacobson's relaxation technique

Interventions

Group A Duration of forty five minutes Warm up exercises for 10 minutes. Free active movement of upper limb, lower limb, and upper body, cross toe to touch dynamic stretches such as lunges, Achilles tendon and hamstrings stretching. The aerobic workout duration will be 25mins.. The aerobic exercise involved the following steps with15reps of each exercise and while changing the step slow marching step for 15second and then move towards the next step. single step touch, double step touch, step touch front and back ,grapevine, knee lift , lunge side and back, L step ,V step, jumping jacks. Cool down exercises for 10 minutes included slow marching, quadriceps and hamstring and stretching. Subjects were prohibited from aerobics during menstruation and data were recorded for two menstrual cycles.

aerobic exercises

Group B Jacobson's relaxation technique is a type of therapy that focuses on tightening and relaxing specific muscle groups in a sequence that makes you feel calmer and makes you aware of your body and physical sensations. It is also known as PMRT. (39) JPRT was applied three times a week from the estimated date of ovulation to the onset of the next menstruation. . The participants were in a supine position and were supported with cushions. The JPRT involves participants actively contracting muscles to create tension and then progressively releasing them. First of all, the participants were asked to contract the muscles tightly and hold for slow count of 5seconds (s) and then relax them completely for 10 s. At the same time, the participants practiced diaphragmatic breathing. The participants repeatedly performed JPMRT for each body part. Each session lasted about 20-30 min.

Also known as: Aerobic exercises and hypopressive
Jacobson's progressive relaxation technique

Eligibility Criteria

Age17 Years - 24 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPrimary Dysmenorrhea, Having a regular menstrual cycle (28-32) days, Normal bleeding days (3 to 1) and diagnosed with mild PD according to WaLiDD score
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pain on numeric rating pain scale,
  • Menarche range 12-16,
  • BMI less than 30,
  • Having a regular menstrual cycle (28-32) days,
  • Normal bleeding days (3 to 1) and diagnosed with mild PD according to WaLiDD score

You may not qualify if:

  • Athletes,
  • married women with gynaecological abnormalities were excluded,
  • Medical treatment during the study (e.g., oral contraceptives, antidepressants)
  • Recent musculoskeletal trauma or surgery, or chronic musculoskeletal disorders
  • affecting pain perception (e.g., fibromyalgia, pelvic floor dysfunction)
  • secondary dysmenorrhea-related conditions (e.g., endometriosis, fibroids, ovarian cysts),
  • consumption of painkillers
  • No mental or physical diseases, which reduce the abilities to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Superior college for women and Polytechnic institute

Okāra, Punjab Province, 52513, Pakistan

RECRUITING

Related Publications (5)

  • Gittens A, Griffiths-Bandoo S, Eccleston A, Irving SW, Dawkins JJJMCNS. How Does Primary Dysmenorrhea Impact the Quality of Life of Young Women Ages (18-35) in a Selected Community in St. James, Jamaica. 2025;3(2):1-4.

    BACKGROUND
  • Wu X, Yuan J, Ni J, Ma X, Zhang Z, Hua Y, et al. Electroacupuncture with different waveforms for primary dysmenorrhea: a randomized controlled trial. 2024;11(3):357-62.

    BACKGROUND
  • Esan DT, Ariyo SA, Akinlolu EF, Akingbade O, Olabisi OI, Olawade DB, et al. Prevalence of dysmenorrhea and its effect on the quality of life of female undergraduate students in Nigeria. 2024;5:100059.

    BACKGROUND
  • Dar M, Khan A, Shah SS, Aleem A, Jaber AAS, Hussain M, Khan GM. Evaluation of health-related quality of life of female students suffering from primary dysmenorrhea: findings of a cross-sectional study from Pakistan. Front Public Health. 2025 Apr 24;13:1467377. doi: 10.3389/fpubh.2025.1467377. eCollection 2025.

    PMID: 40342508BACKGROUND
  • Raule EB, Sapulete IM, Engka JNAJJII. Relationship Between Premenstrual Syndrome (Pms) And Appetite In Female Medical Students At Sam Ratulangi University. 2025;4(1):1071-9.

    BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Exercise

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hafiza Iqra Rubab, MSWHPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

October 1, 2025

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations