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Completed

NCT Number: NCT07525102

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

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

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Key information

Conditions

Primary Dysmenorrhea

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical therapy

Giza, Dokki, 12611, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Assessment of pain severity

    Time frame: 12 weeks

    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.

  2. Assessment of symptoms of dysmenorrhea

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Assessment of quality of life enjoyment and satisfaction

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: PD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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