Effect of Progressive Relaxation Versus Isometric Exercises in Management of Primary Dysmenorrhea (PD)

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

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Other: Progressive Relaxation Exercises; Behavioral: Lifestyle modification advices; Other: Isometric Exercises

Detailed Description

The prevalence of dysmenorrhea varies between 16% and 91% in women of reproductive age, with severe pain in 2%-29% of the women studied. It has major implications for quality of life, such as limitation of daily activities and psychological stress, being one of the main causes of work absenteeism. Despite the significant effects on quality of life, the prevalence of primary dysmenorrhea is considered to be underestimated because women frequently do not seek medical treatment because of the commonly held belief that pain is an expected part of menstruation.

The prolonged use of NSAIDs is also associated with cardiovascular, hepatic, and renal problems. Likewise, oral contraceptives are not free from side effects either, as they increase the frequency of bleeding, weight gain, and risk of venous thromboembolism. So, there is a need for emphasis on alternative methods of conservative treatment as non-pharmacological and non-invasive therapy, as it is safe and easy to use for obtaining relief from dysmenorrhea symptoms.

Progressive relaxation exercises have been proven to have an impact on decreasing dysmenorrhea pain when they are practiced on a regular basis. Isometric exercises are easy and safe for sedentary population as the protocol is non-invasive and implemented at low intensity, and they are widely used in rehabilitation settings. Also, it is inexpensive as no special facilities or equipment are required, and not time-consuming. Hence, isometric exercises seems to be an appropriate non-pharmacological method for reducing the pain intensity of primary dysmenorrhea.

So, this study is an attempt to increase the body of knowledge in the field of physical therapy, as it will be the first one to investigate the difference between the effect of progressive relaxation exercises and isometric exercises in management of primary dysmenorrhea.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt, 12611
      • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progressive Relaxation + Lifestyle modification advices; 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; 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.; Behavioral: Lifestyle modification advices; 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.
Experimental: Isometric Exercises + Lifestyle modification advices; 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.	Behavioral: Lifestyle modification advices; 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.; Other: Isometric Exercises; 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.
Active Comparator: Lifestyle modification advices; It will consist of 20 participants with primary dysmenorrhea. They will receive lifestyle modification advices for 12 weeks.	Behavioral: Lifestyle modification advices; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of quality of life enjoyment and satisfaction	The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) will be used to assess overall life satisfaction across multiple domains, including physical health, mood, work, daily activities, social relationships, economic status, and overall well-being. It is a validated self-reported measure of enjoyment and satisfaction in daily life. Participants will rate each item on a 5-point scale ranging from "very poor" to "very good." Total scores will be calculated as a percentage of the maximum possible score, with higher scores indicating better quality of life. A score above 70% will be considered indicative of normal quality of life.	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Azza Barmoud Nashed Kassab, PhD, Professor, Cairo university; Study Director: Mai Mohamed Ali Shehata, PhD, Ass. Professor, Cairo University; Study Director: Mohamed Fawzy Abou Elenen, PhD, Consultant, Om El Masryeen

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Actual): July 4, 2025
• Study Completion (Actual): October 20, 2025

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: P.T.REC/012/004725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No