Primary DysmenorrheaNCT06317532
Effect of Functional Exercises on Pain and Quality of Life in Females With Primary Dysmenorrhea
A study testing Lifestyle modification advice and Functional exercises in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study will be to investigate the effect of functional exercises on pain and quality of life in females with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Lifestyle modification advice and Functional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2024to 20 May 2024
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Their ages will be ranged from 18 to 25 years
- They will be suffering from primary dysmenorrhea based on the Menstrual Distress questionnaire.
- Their BMI will be ranged from 20 to 25 kg/m2.
- Having regular menstrual cycles (one every 28-34 days).
- They will be sedentary virgin females.
- They are non-smokers.
- They have not been in any exercise program for three months.
Who cannot join
- Having secondary dysmenorrhea.
- Using regular medication or contraceptive pills.
- Having neuromuscular, metabolic, or cardiac diseases.
- Having a preexisting condition prevents them from engaging in an exercise program.
Trial locations and contacts
1 site in 1 country.
Mai Mohamed Ali, PhD contact
Egypt1 site
Cairo University
Giza
Manar E. Al-Emary, M.Sc. Stud, +20 128 660 0931, manaralemary@gmail.com
Mai Mohamed Ali, PhD
About this study
The aim of the study will be to investigate the effect of functional exercises on pain and quality of life in females with primary dysmenorrhea.
Read the detailed description
Primary dysmenorrhea and menstrual pain are significant health, social and economic problems. It involves a broad spectrum of physical and emotional manifestations, with 50% to 91 % prevalence in young women.
Women with primary dysmenorrhea report significantly lower quality of life because of bodily pain, general health condition, and physical and social functioning. It compromises the most common gynecological alternations and is the primary cause of women's academic and work absenteeism, which reduces the quality of life, daily activities, and economic situation due to decreased working hours.
Non-Steroidal Anti-Inflammatory Drugs are the first therapeutic line for primary dysmenorrhea; however, they might be accompanied by undesirable side effects, such as dyspepsia, headache, and drowsiness.
So, there is a need for safe interventions with no side effects. Therefore, this study aims to investigate the effects of functional exercises on pain and quality of life in females with primary dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Lifestyle modification advice, Functional exercises
- Keywords
- Primary Dysmenorrhea, Functional Exercises, Pain, Quality of Life
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modification adviceOther
All female participants in groups A and B will be provided with lifestyle modification advice, including recommendations such as reducing caffeine intake, limiting salt consumption, decreasing animal fat consumption, quitting smoking, practicing relaxation techniques, applying heat when needed, considering the use of herbal agents, avoiding cold drinks and foods, and opting for loose, cotton clothing.
Functional exercisesOther
Each female in group (B) will perform the exercise program three times a week for eight weeks at the University Women's Health Unit Exercise protocols mainly consist of relaxation, strengthening, stretching, aerobic exercises, pelvic floor muscle strengthening exercises, yoga, and Pilates
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification advice | Active comparator | It will include 29 females suffering from primary dysmenorrhea. They will be asked to follow lifestyle modification advice during the program duration. Receives: Other: Lifestyle modification advice |
| Lifestyle modification advice + Functional exercises | Experimental | It will include 29 females suffering from primary dysmenorrhea. They will be given the same lifestyle modification advice as group A, in addition to performing a combination of various functional exercises (including two stretching exercises, one yoga position, two core-strengthening exercises, two pelvic area exercises, and Kegel exercises), for 45 minutes per session, three times /week for eight weeks. Receives: Other: Lifestyle modification advice; Other: Functional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
It will be used to measure pain intensity for each female in both groups (A\&B) before and after the end of treatment. The VAS is usually presented as a 10 cm horizontal line on which the participants' pain intensity is represented by a point between the extremes of "no pain at all "and "worst pain imaginable. " Its simplicity, reliability, and validity, as well as its ratio scale properties, make the VAS the optional tool for describing pain intensity.
Measured: 8 weeks
The Menstrual Distress Questionnaire
It will be used to evaluate menstruation symptoms and distress for each female in both groups (A\&B) before and after the end of treatment. It consists of symptoms or feelings associated with menstruation. The total number of items is 47. It is a 5-point rating scale from 0-4. Each item has five options, i.e., No, mild, moderate, severe, and very severe. An option of (very severe) has a score of 4, (severe) has a score of 3, (moderate) has a score of 2, (mild) has a score of 1, (No) has a score of 0. It includes seven subscales as (pain, water retention, autonomic reactions, negative affect, impaired concentration, mood and behavioral changes, and arousal control). The overall score was interpreted as follows: <50 - mild, 50 to 70 - moderate, and >70 severe.
Measured: 8 weeks
Secondary outcomes (2)
Quality of life enjoyment and satisfaction questionnaire
It will be used to assess health-related quality of life for participants of both groups (A\&B) before and after the end of the treatment program. It consists of items that evaluate overall enjoyment and satisfaction regarding; Physical Health, mood, work, household and leisure activities, family and social relationships, ability to function in daily life, economic status, living or housing situation, ability to get around physically, ability to do work or hobbies, and overall sense of being. Responses will be scored on a five-point scale (from "very poor" to "very good"), where higher scores indicate better enjoyment and satisfaction with life. Scores will be added and presented as a percentage of the total maximum score. A percentage of the total score of > 70 represents the normal quality of life.
Measured: 8 weeks
Pressure pain threshold assessment
A pressure algometry will be used to measure pressure pain thresholds for all participants in both groups (A\&B) before and after the end of the treatment program.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start20 Mar 2024 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion20 May 2024 (estimated)
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Essam Al-Emary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317532
- Sponsor's protocol ID
- P.T.REC/012/004766
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Exercises on Pain and Quality of Life in Females With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06317532
- Acronym / sponsor ID
- P.T.REC/012/004766
- Conditions
- Primary Dysmenorrhea
- Keywords
- Primary Dysmenorrhea, Functional Exercises, Pain, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 19 Mar 2024 (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.
The aim of the study will be to investigate the effect of functional exercises on pain and quality of life in females with primary dysmenorrhea.
Detailed description
Primary dysmenorrhea and menstrual pain are significant health, social and economic problems. It involves a broad spectrum of physical and emotional manifestations, with 50% to 91 % prevalence in young women.
Women with primary dysmenorrhea report significantly lower quality of life because of bodily pain, general health condition, and physical and social functioning. It compromises the most common gynecological alternations and is the primary cause of women's academic and work absenteeism, which reduces the quality of life, daily activities, and economic situation due to decreased working hours.
Non-Steroidal Anti-Inflammatory Drugs are the first therapeutic line for primary dysmenorrhea; however, they might be accompanied by undesirable side effects, such as dyspepsia, headache, and drowsiness.
So, there is a need for safe interventions with no side effects. Therefore, this study aims to investigate the effects of functional exercises on pain and quality of life in females with primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification advice | Active comparator | Other: Lifestyle modification adviceIt will include 29 females suffering from primary dysmenorrhea. They will be asked to follow lifestyle modification advice during the program duration. |
| Lifestyle modification advice + Functional exercises | Experimental | Other: Lifestyle modification advice, Other: Functional exercisesIt will include 29 females suffering from primary dysmenorrhea. They will be given the same lifestyle modification advice as group A, in addition to performing a combination of various functional exercises (including two stretching exercises, one yoga position, two core-strengthening exercises, two pelvic area exercises, and Kegel exercises), for 45 minutes per session, three times /week for eight weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Their ages will be ranged from 18 to 25 years
- They will be suffering from primary dysmenorrhea based on the Menstrual Distress questionnaire.
- Their BMI will be ranged from 20 to 25 kg/m2.
- Having regular menstrual cycles (one every 28-34 days).
- They will be sedentary virgin females.
Key exclusion criteria (4 listed)
- Having secondary dysmenorrhea.
- Using regular medication or contraceptive pills.
- Having neuromuscular, metabolic, or cardiac diseases.
- Having a preexisting condition prevents them from engaging in an exercise program.
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 |
|---|---|---|
| Lifestyle modification adviceAll female participants in groups A and B will be provided with lifestyle modification advice, including recommendations such as reducing caffeine intake, limiting salt consumption, decreasing animal fat consumption, quitting smoking, practicing relaxation techniques, applying heat when needed, considering the use of herbal agents, avoiding cold drinks and foods, and opting for loose, cotton clothing. | Other | Lifestyle modification advice, Lifestyle modification advice + Functional exercises |
| Functional exercisesEach female in group (B) will perform the exercise program three times a week for eight weeks at the University Women's Health Unit Exercise protocols mainly consist of relaxation, strengthening, stretching, aerobic exercises, pelvic floor muscle strengthening exercises, yoga, and Pilates | Other | Lifestyle modification advice + Functional exercises |
Primary outcome
Visual analogue scale (VAS)
Time frame: 8 weeks
It will be used to measure pain intensity for each female in both groups (A\&B) before and after the end of treatment. The VAS is usually presented as a 10 cm horizontal line on which the participants' pain intensity is represented by a point between the extremes of "no pain at all "and "worst pain imaginable. " Its simplicity, reliability, and validity, as well as its ratio scale properties, make the VAS the optional tool for describing pain intensity.
The Menstrual Distress Questionnaire
Time frame: 8 weeks
It will be used to evaluate menstruation symptoms and distress for each female in both groups (A\&B) before and after the end of treatment. It consists of symptoms or feelings associated with menstruation. The total number of items is 47. It is a 5-point rating scale from 0-4. Each item has five options, i.e., No, mild, moderate, severe, and very severe. An option of (very severe) has a score of 4, (severe) has a score of 3, (moderate) has a score of 2, (mild) has a score of 1, (No) has a score of 0. It includes seven subscales as (pain, water retention, autonomic reactions, negative affect, impaired concentration, mood and behavioral changes, and arousal control). The overall score was interpreted as follows: <50 - mild, 50 to 70 - moderate, and >70 severe.
2 secondary outcomes
Quality of life enjoyment and satisfaction questionnaire
Time frame: 8 weeks
Pressure pain threshold assessment
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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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.
Mai Mohamed Ali, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification advice and Functional exercises 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 7 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manar E. Al-Emary, M.Sc. Stud (+20 128 660 0931, manaralemary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: 8 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 20 Mar 2024.