Primary DysmenorrheaNCT05709951
Effects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea
A study testing Functional Exercises and Core Stability Exercises in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of Functional and Core stability exercises on pain and sleep quality in Patients with Primary Dysmenorrhea and to check the results of exercises may be effective in pain during Menstrual and before cramping in menses. Read more about this study
- Who is it for?
- Ages 15 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Functional Exercises and Core Stability Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to Feb 2023
- 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 15 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Having used medication for menstrual pain and not having used oral contraceptives during the three months prior to admission to the study.
- Pain must be periodic (at least following 3 menstrual cycles).
- Lower abdominal cramps pain ends after periods and gradually diminish over 12 to 72 hrs.
- No history of blood disorders including thalassemia and folate or iron-deficiency anemia
Who cannot join
- Pelvic inflammatory disease
- Ovarian cysts
- Chronic abdominal pain
- Fibroids, obstructive endometrial polyps,
- Irritable bowel syndrome
- Major abdominal or pelvic surgery
- Intrauterine devices.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah Hospital
Lahore, Punjab Province
Hamid Sarwer, PG
Hamid Sarwer, Masters*
About this study
To compare the effects of Functional and Core stability exercises on pain and sleep quality in Patients with Primary Dysmenorrhea and to check the results of exercises may be effective in pain during Menstrual and before cramping in menses.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Functional Exercises, Core Stability Exercises
- Keywords
- Core stability,Exercises,Primary dysmenorrhea,sleep quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional ExercisesOther
Also called Exercises
The patients were requested to perform these functional exercises for 4 days per week three times for 20 min (8 weeks).
Core Stability ExercisesOther
Also called Exercises
The patients were requested to perform 4 core strengthening exercises for 4 days per week three times for 20 min (8 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Functional exercises | Active comparator | Piriformis stretching Cobra pose Sit up Bridging exercise Receives: Other: Functional Exercises |
| Core Stability Exercises | Active comparator | Pelvic bridging Plank Cat and camel Curl up Receives: Other: Core Stability Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale for lower abdominal pain
The subjective and verified visual analogue scale is used to quantify both acute and chronic pain (1). On the 10 cm line, scores are recorded by making a mark. Pain intensity is measured along a 10-cm line with 0 denoting "no pain" and 10 denoting "worst pain."
Measured: 8 week
Menstrual Symptom Questionnaire
Menstrual Symptom Questionnaire (MSQ) to assess dysmenorrhea symptoms. The MSQ is a 24 item self-report measure which assesses menstrual pain and symptoms (e.g. 'I have cramps that begin on the first day of my period'; 'I feel depressed for several days before my period'). The score on each item ranges from 1 (never) to 5 (always) with a higher composite score indicating more symptoms.
Measured: 8 weeks
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI) evaluates sleep disruptions and quality over a 1-month period. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty).
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Feb 2022
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (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 Riphah International 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
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatima Tariq, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709951
- Sponsor's protocol ID
- RiphahIU fatimatariq1
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 2 Feb 2023
- 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 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05709951
- Acronym / sponsor ID
- RiphahIU fatimatariq1
- Conditions
- Primary Dysmenorrhea
- Keywords
- Core stability,Exercises,Primary dysmenorrhea,sleep quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 2 Feb 2023 (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.
To compare the effects of Functional and Core stability exercises on pain and sleep quality in Patients with Primary Dysmenorrhea and to check the results of exercises may be effective in pain during Menstrual and before cramping in menses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional exercises | Active comparator | Other: Functional ExercisesPiriformis stretching Cobra pose Sit up Bridging exercise |
| Core Stability Exercises | Active comparator | Other: Core Stability ExercisesPelvic bridging Plank Cat and camel Curl up |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Having used medication for menstrual pain and not having used oral contraceptives during the three months prior to admission to the study.
- Pain must be periodic (at least following 3 menstrual cycles).
- Lower abdominal cramps pain ends after periods and gradually diminish over 12 to 72 hrs.
- No history of blood disorders including thalassemia and folate or iron-deficiency anemia
Key exclusion criteria (7 listed)
- Pelvic inflammatory disease
- Ovarian cysts
- Chronic abdominal pain
- Fibroids, obstructive endometrial polyps,
- Irritable bowel syndrome
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 |
|---|---|---|
| Functional ExercisesAlso: ExercisesThe patients were requested to perform these functional exercises for 4 days per week three times for 20 min (8 weeks). | Other | Functional exercises |
| Core Stability ExercisesAlso: ExercisesThe patients were requested to perform 4 core strengthening exercises for 4 days per week three times for 20 min (8 weeks) | Other | Core Stability Exercises |
Primary outcome
Visual analogue scale for lower abdominal pain
Time frame: 8 week
The subjective and verified visual analogue scale is used to quantify both acute and chronic pain (1). On the 10 cm line, scores are recorded by making a mark. Pain intensity is measured along a 10-cm line with 0 denoting "no pain" and 10 denoting "worst pain."
Menstrual Symptom Questionnaire
Time frame: 8 weeks
Menstrual Symptom Questionnaire (MSQ) to assess dysmenorrhea symptoms. The MSQ is a 24 item self-report measure which assesses menstrual pain and symptoms (e.g. 'I have cramps that begin on the first day of my period'; 'I feel depressed for several days before my period'). The score on each item ranges from 1 (never) to 5 (always) with a higher composite score indicating more symptoms.
Pittsburgh Sleep Quality Index
Time frame: 8 week
Pittsburgh Sleep Quality Index (PSQI) evaluates sleep disruptions and quality over a 1-month period. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Primary Dysmenorrhea
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Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
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The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
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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.
Fatima Tariq, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Exercises and Core Stability Exercises in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 7 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 2 Feb 2023. 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 Pakistan. 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 Fatima Tariq, Phd (03344255033, fatima.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale for lower abdominal pain (time frame: 8 week). The study lists 3 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 2 Feb 2023.