Primary DysmenorrheaPDNCT07525102
Effect of Progressive Relaxation Versus Isometric Exercises in Management of Primary Dysmenorrhea
A study testing Progressive Relaxation Exercises, Isometric Exercises and Lifestyle modification advices in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to compare the effect of progressive relaxation and isometric exercises in management of primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Progressive Relaxation Exercises, Isometric Exercises and Lifestyle modification advices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2024to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to compare the effect of progressive relaxation and isometric exercises in management of primary dysmenorrhea.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Progressive Relaxation Exercises, Isometric Exercises, Lifestyle modification advices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Relaxation ExercisesOther
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 ExercisesOther
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 advicesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Lifestyle modification advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start11 Nov 2024
- Primary completion4 Jul 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Essam Abd Elmonem Ahmed, Cairo University
- Investigators
- Azza Barmoud Nashed Kassab, PhD, Study chair, Professor, Cairo UniversityMai Mohamed Ali Shehata, PhD, Study director, Ass. Professor, Cairo UniversityMohamed Fawzy Abou Elenen, PhD, Study director, Consultant, Om El Masryeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525102
- Sponsor's protocol ID
- P.T.REC/012/004725
- Acronym
- PD
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progressive Relaxation Versus Isometric Exercises in Management of Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07525102
- Acronym / sponsor ID
- PD / P.T.REC/012/004725
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to compare the effect of progressive relaxation and isometric exercises in management of primary dysmenorrhea.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Progressive Relaxation + Lifestyle modification advices | Experimental | Other: Progressive Relaxation Exercises, Behavioral: Lifestyle modification advicesIt 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. |
| Isometric Exercises + Lifestyle modification advices | Experimental | Other: Isometric Exercises, Behavioral: Lifestyle modification advicesIt 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. |
| Lifestyle modification advices | Active comparator | Behavioral: Lifestyle modification advicesIt will consist of 20 participants with primary dysmenorrhea. They will receive lifestyle modification advices for 12 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Relaxation ExercisesProgressive 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. | Other | Progressive Relaxation + Lifestyle modification advices |
| Isometric ExercisesParticipants 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. | Other | Isometric Exercises + Lifestyle modification advices |
| Lifestyle modification advicesAll 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. | Behavioural | Isometric Exercises + Lifestyle modification advices, Lifestyle modification advices, Progressive Relaxation + Lifestyle modification advices |
Primary outcome
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.
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.
1 secondary outcome
Assessment of quality of life enjoyment and satisfaction
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Primary Dysmenorrhea
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The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azza Barmoud Nashed Kassab, PhD study chair
Professor, Cairo University
Mai Mohamed Ali Shehata, PhD study director
Ass. Professor, Cairo University
Mohamed Fawzy Abou Elenen, PhD study director
Consultant, Om El Masryeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Relaxation Exercises, Isometric Exercises and Lifestyle modification advices in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain severity (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.