Effect of Progressive Relaxation Versus Isometric Exercises in Management of Primary Dysmenorrhea

NCT07525102 | Completed

• 1 other identifier: P.T.REC/012/004725
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to compare the effect of progressive relaxation and isometric exercises in management of primary dysmenorrhea.

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (2)

• Assessment of pain severity

  Pain intensity will be assessed for all participants in the three groups before and after the intervention using the Visual Analog Scale (VAS). The VAS is a one-dimensional measure consisting of a 10 cm horizontal line representing a continuum from "no pain" to "worst imaginable pain." Participants will be instructed to mark a point on the line that best reflects their current pain intensity, and the score will be determined by measuring the distance from the "no pain" end.

  12 weeks

• Assessment of symptoms of dysmenorrhea

  The Menstrual Distress Questionnaire (MDQ) will be used to assess symptom severity in all groups (A, B, and C) before and after treatment. Participants will rate their experience of each symptom on a scale ranging from no symptoms to severe or partially disabling symptoms. The MDQ consists of eight subscales: pain, impaired concentration, behavioral change, autonomic reactions, water retention, negative affect, arousal, and control. Symptoms are typically rated on a 4-point scale (0 = no symptoms to 3 = severe symptoms) or, in some versions, a 6-point scale. Subscale scores will be calculated by summing item ratings within each category, with higher scores indicating greater menstrual distress.

  12 weeks

Secondary Outcomes (1)

• Assessment of quality of life enjoyment and satisfaction

  12 weeks

Study Arms (3)

Progressive Relaxation + Lifestyle modification advices

EXPERIMENTAL

It will consist of 20 participants with primary dysmenorrhea. They will receive progressive relaxation techniques three times per week, for 30 minutes once daily and will follow lifestyle modification advices for 3 consecutive menstrual cycles for 12 weeks.

Other: Progressive Relaxation Exercises; Behavioral: Lifestyle modification advices

Isometric Exercises + Lifestyle modification advices

EXPERIMENTAL

It will consist of 20 participants with primary dysmenorrhea. They will perform isometric exercises 5 days a week, two sessions a day, for 10 times per session and also followed lifestyle modification for 3 consecutive menstrual cycles for 12 weeks.

Other: Isometric Exercises; Behavioral: Lifestyle modification advices

Lifestyle modification advices

ACTIVE COMPARATOR

It will consist of 20 participants with primary dysmenorrhea. They will receive lifestyle modification advices for 12 weeks.

Behavioral: Lifestyle modification advices

Interventions

Progressive Relaxation Exercises OTHER

Progressive relaxation exercises will be performed using controlled breathing combined with sequential muscle contraction and relaxation. Participants will be instructed to contract specific muscle groups during inspiration for 5-7 seconds, followed by relaxation during expiration for 15-20 seconds while focusing on the sensation of release. The sequence will include movements of the toes (flexion/extension, abduction/adduction), subtalar inversion/eversion, ankle dorsiflexion/plantarflexion, finger flexion/extension and abduction/adduction, as well as wrist flexion/extension and radial/ulnar deviation. This protocol will be carried out in a structured manner for approximately 25 minutes.

Progressive Relaxation + Lifestyle modification advices

Lifestyle modification advices BEHAVIORAL

All groups will receive lifestyle modification advice, including reducing caffeine, salt, and animal fat intake, quitting smoking, practicing relaxation techniques, applying heat, using herbal remedies, avoiding cold foods and drinks, and wearing loose cotton clothing. Participants in groups A and B will also receive the same lifestyle modification guidance alongside their respective interventions.

Isometric Exercises + Lifestyle modification advices; Lifestyle modification advices; Progressive Relaxation + Lifestyle modification advices

Isometric Exercises OTHER

Participants will be instructed on the nature and correct performance of the exercises prior to the first session. The program will be performed 5 days per week, twice daily, with each session lasting 10 minutes for 12 weeks. Each session will consist of seven stages performed in a supine position, including pressing the feet together, crossing and pressing the legs, squeezing a pillow between the knees, pressing the lower back against the ground, and performing head and neck lifting and directional movements toward each thigh. Each contraction will be held for 5 seconds followed by relaxation.

Isometric Exercises + Lifestyle modification advices

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The regularity of the menstrual cycle is 28 to 34 days.
• All of them suffer from moderate and severe dysmenorrhea pain on visual analogue scale.
• Their BMI will be less than 30 kg\\m2.

You may not qualify if:

• Any pathological findings in the pelvic cavity as polycystic ovarian syndrome, endometriosis and pelvic inflammatory disease.
• Any history of gynecological intervention.
• Secondary dysmenorrhea.
• Irregular menstruation

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical therapy

Giza, Dokki, 12611, Egypt

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Azza Barmoud Nashed Kassab, PhD

  Professor, Cairo University

  STUDY CHAIR

• Mai Mohamed Ali Shehata, PhD

  Ass. Professor, Cairo University

  STUDY DIRECTOR

• Mohamed Fawzy Abou Elenen, PhD

  Consultant, Om El Masryeen

  STUDY DIRECTOR

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: March 24, 2024
• First Posted: April 13, 2026
• Study Start: November 11, 2024
• Primary Completion: July 4, 2025
• Study Completion: October 20, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)