DysmenorrheaNCT07036913
Effectiveness of ST With TENS and Stretching Exercises on Menstrual Pain and QOL With Dysmenorrhea. RCT
A study testing somatocognitive therapy and Stretching exercises in people with Dysmenorrhea, run by Superior University at 1 site in Pakistan.
Trial summary
Effectiveness of somatocognitive therapy with TENS and stretching exercises on menstrual pain and quality of life with dysmenorrhea.A randomized controlled trial The objective of this study is to find weather which therapy; somatocognitive therapy along with TENS or stretching exercises is more effective and what are… Read more about this study
- Who is it for?
- Ages 13 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- somatocognitive therapy and Stretching exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Females who are facing menustral pain during their every menses.
- Females who are facing dysmonarrhea from the at least last three months.
- Females who are willing to take part in the research.
Who cannot join
- Females with some hormonal problem.
- Females with irregular menustral cycle.
- Females who face menustral pain during some of their menses
- Pregnant females
- Females with recent abdominal/pelvic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Somatocognitive Therapy With TENS and Stretching Exercises on Menstrual Pain and Quality of Life With Dysmenorrhea.A Randomized Controlled Trial.
Effectiveness of somatocognitive therapy with TENS and stretching exercises on menstrual pain and quality of life with dysmenorrhea.A randomized controlled trial The objective of this study is to find weather which therapy; somatocognitive therapy along with TENS or stretching exercises is more effective and what are their effects on quality of life in females with dysmonarrhea.
Read the detailed description
The Study spans the population into two groups. For first group we will give somatocognitive therapy (drawing and music) along with TENS and in second group we will give stretching exercises. In both groups the hotpack will be the common treatment.
The nature of this study will be randomized controlled trial . We will use simple random sampling technique in this study.
For outcomes measurements we will use numerical rating scale and menustral distress questionere .
- Conditions
- Dysmenorrhea
- Being tested
- somatocognitive therapy, Stretching exercises
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatocognitive therapyDiagnostic test
In somatocognitive therapy which includes drawing( three days prior to menustration in first two months and the first day of menustration in third month) and music(in the first 12 hours of menustration)along with TENS(thirty minutes on abdominal region, upon the onset of dysmonarrhea).
Stretching exercisesCombination product
Stretching exercises of abdominal, lumbar or pelvic region will be performed as a treatment. Frequency:15 minutes;three times per week.
| Study group | Role | What they receive |
|---|---|---|
| somatocognitive therapy | Experimental | Not described Receives: Diagnostic Test: somatocognitive therapy |
| Stretching exercises | Active comparator | Not described Receives: Combination Product: Stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale
A pain screening tool, commonly use to assess pain severity at that moment in time using a 0-10 scale, with 0 meaning "no pain" and 10 meaning "the worst pain".
Measured: 6 Month
Menstrual distress questionnaire
The MSQ is a 24-46 item self-report measure which assesses menstrual pain and symptoms .The score on each item ranges from 1 (never) to 5 (always) with a higher composite score indicating more symptoms.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start4 Mar 2025
- Primary completion1 Jun 2025
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036913
- Sponsor's protocol ID
- DPT/Batch-Fall20/1002
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Somatocognitive Therapy With TENS and Stretching Exercises on Menstrual Pain and Quality of Life With Dysmenorrhea.A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07036913
- Acronym / sponsor ID
- DPT/Batch-Fall20/1002
- Conditions
- Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Jun 2025 (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.
Effectiveness of somatocognitive therapy with TENS and stretching exercises on menstrual pain and quality of life with dysmenorrhea.A randomized controlled trial The objective of this study is to find weather which therapy; somatocognitive therapy along with TENS or stretching exercises is more effective and what are their effects on quality of life in females with dysmonarrhea.
Detailed description
The Study spans the population into two groups. For first group we will give somatocognitive therapy (drawing and music) along with TENS and in second group we will give stretching exercises. In both groups the hotpack will be the common treatment.
The nature of this study will be randomized controlled trial . We will use simple random sampling technique in this study.
For outcomes measurements we will use numerical rating scale and menustral distress questionere .
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| somatocognitive therapy | Experimental | Diagnostic Test: somatocognitive therapy |
| Stretching exercises | Active comparator | Combination Product: Stretching exercises |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Females who are facing menustral pain during their every menses.
- Females who are facing dysmonarrhea from the at least last three months.
- Females who are willing to take part in the research.
Key exclusion criteria (5 listed)
- Females with some hormonal problem.
- Females with irregular menustral cycle.
- Females who face menustral pain during some of their menses
- Pregnant females
- Females with recent abdominal/pelvic surgery.
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 |
|---|---|---|
| somatocognitive therapyIn somatocognitive therapy which includes drawing( three days prior to menustration in first two months and the first day of menustration in third month) and music(in the first 12 hours of menustration)along with TENS(thirty minutes on abdominal region, upon the onset of dysmonarrhea). | Diagnostic test | somatocognitive therapy |
| Stretching exercisesStretching exercises of abdominal, lumbar or pelvic region will be performed as a treatment. Frequency:15 minutes;three times per week. | Combination product | Stretching exercises |
Primary outcome
Numerical rating scale
Time frame: 6 Month
A pain screening tool, commonly use to assess pain severity at that moment in time using a 0-10 scale, with 0 meaning "no pain" and 10 meaning "the worst pain".
Menstrual distress questionnaire
Time frame: 6 Months
The MSQ is a 24-46 item self-report measure which assesses menstrual pain and symptoms .The score on each item ranges from 1 (never) to 5 (always) with a higher composite score indicating more symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing somatocognitive therapy and Stretching exercises in people with Dysmenorrhea, run by Superior 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Numerical rating scale (time frame: 6 Month). 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 25 Jun 2025.