Primary DysmenorrheaNCT06401226
Pain and Physical Fitness in Primary Dysmenorrhea
An observational study of Primary Dysmenorrhea, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization in 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
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to Mar 2025
- Phase
- Observational
- 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
Study population: The primary dysmenorrhea group will consist of cases diagnosed by a gynecologist. The Control Group will consist of healthy women who meet inclusion criteria.
Who may be able to join
- Between the ages of 18-25
- Body mass index of 18-25 kg/m2
- Having a regular menstrual cycle (28±7 days)
- For the PD Group; pain level >5 according to VAS during menstruation
- For the Control Group; having a VAS score of 5 or less
Who cannot join
- Having given birth before
- Using an intrauterine device
- Having a health problem that causes chronic pain
- Having a diagnosis of neurological, orthopedic, vestibular, rheumatological disorder
- Being diagnosed with a gynecological or pelvic disorder such as endometriosis, ovarian cyst
- Having a history of abdominal or gynecological surgery within the last year
Show all 9Show fewer
- Being on oral contraceptive use/hormonal therapy or antidepressant treatment
- Having used painkillers 12 hours before the evaluation
- Participating in a regular exercise program
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul
Kubra Alpay, PhD
Alis Kostanoglu, Assoc. Prof.
About this study
Official title: Evaluation of Pain and Physical Fitness in Primary Dysmenorrhea
The aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization in primary dysmenorrhea.
Read the detailed description
Primary dysmenorrhea (PD) is a condition that occurs just before or during menstruation and is accompanied by cramp-like pain in the lower abdomen, without any pelvic pathology. Pain usually begins just before or during menstruation and ends within 12-72 hours. Most women with PD describe their menstrual pain as moderate to severe, which significantly affects their activities of daily living and school and work performance.
In PD, functions and activities of daily living are also affected due to pain and other hormonal changes. Studies have reported that musculoskeletal problems such as decreased spinal mobility, pelvic stability and postural control are observed in women with dysmenorrhea.
The aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization during the menstruation and on a non-menstrual day of the cycle, in primary dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary Dysmenorrhea | Women with primary dysmenorrhea according to the Primary Dysmenorrhea Consensus Guide and those with pain > 5 according to visual analog scale | |
| Control Group | Women who do not experience painful cramps during their menstrual period or who have a visual analog scale score < 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Pain assessment will be evaluated with a visual analog scale. Subjects will be asked to mark the intensity of the pain they feel on a 10 cm line, where "0" means no pain and "10" means very severe pain.
Measured: 2 weeks
Core stability
A pressurized biofeedback device will be used to evaluate core stability. The device will initially be set to 70 mmHg pressure and changes in pressure will be recorded for analysis at the end of the evaluation.
Measured: 2 weeks
Lower extremity muscle strength
A 30-second sit to stand test will be used to evaluate the individual's lower extremity muscle strength and functional capacity. The number of repetitions performed in 30 seconds is recorded.
Measured: 2 weeks
Balance
Biodex Balance System (Biodex Medical Systems, Inc. USA) will be used in the dynamic postural stability test and sensory integration of balance clinical test evaluations.
Measured: 2 weeks
Secondary outcomes (3)
Lower extremity flexibility
Lower extremity flexibility will be performed with a sit-and-reach test. Evaluation will be carried out by measuring the distance between the platform and the hands of the subjects at the last point they can reach while reaching forward with their hands.
Measured: 2 weeks
Menstrual symptoms
Menstrual Symptom Questionnaire will be used to evaluate pain and symptoms related to menstruation. The scale score is calculated by taking the total score average of the items in the scale. An increase in the average score indicates an increase in the severity of menstrual symptoms.
Measured: 2 weeks
Depression, anxiety and stress symptoms
Depression Anxiety Stress Scale will be used. The scale consists of 3 sub-dimensions. Higher scores indicate an increase of severity of symptoms for each sub-dimensions.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Jun 2023
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (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 Bezmialem Vakif 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kubra Alpay, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401226
- Sponsor's protocol ID
- KA24-1
- Status last verified
- Sep 2024
- First submitted
- 21 Mar 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain and Physical Fitness in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06401226
- Acronym / sponsor ID
- KA24-1
- Conditions
- Primary Dysmenorrhea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 6 May 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 this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization in primary dysmenorrhea.
Detailed description
Primary dysmenorrhea (PD) is a condition that occurs just before or during menstruation and is accompanied by cramp-like pain in the lower abdomen, without any pelvic pathology. Pain usually begins just before or during menstruation and ends within 12-72 hours. Most women with PD describe their menstrual pain as moderate to severe, which significantly affects their activities of daily living and school and work performance.
In PD, functions and activities of daily living are also affected due to pain and other hormonal changes. Studies have reported that musculoskeletal problems such as decreased spinal mobility, pelvic stability and postural control are observed in women with dysmenorrhea.
The aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization during the menstruation and on a non-menstrual day of the cycle, in primary dysmenorrhea.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Dysmenorrhea | – | –Women with primary dysmenorrhea according to the Primary Dysmenorrhea Consensus Guide and those with pain > 5 according to visual analog scale |
| Control Group | – | –Women who do not experience painful cramps during their menstrual period or who have a visual analog scale score < 5 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The primary dysmenorrhea group will consist of cases diagnosed by a gynecologist. The Control Group will consist of healthy women who meet inclusion criteria.
Key inclusion criteria (5 listed)
- Between the ages of 18-25
- Body mass index of 18-25 kg/m2
- Having a regular menstrual cycle (28±7 days)
- For the PD Group; pain level >5 according to VAS during menstruation
- For the Control Group; having a VAS score of 5 or less
Key exclusion criteria (9 listed)
- Having given birth before
- Using an intrauterine device
- Having a health problem that causes chronic pain
- Having a diagnosis of neurological, orthopedic, vestibular, rheumatological disorder
- Being diagnosed with a gynecological or pelvic disorder such as endometriosis, ovarian cyst
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain assessment
Time frame: 2 weeks
Pain assessment will be evaluated with a visual analog scale. Subjects will be asked to mark the intensity of the pain they feel on a 10 cm line, where "0" means no pain and "10" means very severe pain.
Core stability
Time frame: 2 weeks
A pressurized biofeedback device will be used to evaluate core stability. The device will initially be set to 70 mmHg pressure and changes in pressure will be recorded for analysis at the end of the evaluation.
Lower extremity muscle strength
Time frame: 2 weeks
A 30-second sit to stand test will be used to evaluate the individual's lower extremity muscle strength and functional capacity. The number of repetitions performed in 30 seconds is recorded.
Balance
Time frame: 2 weeks
Biodex Balance System (Biodex Medical Systems, Inc. USA) will be used in the dynamic postural stability test and sensory integration of balance clinical test evaluations.
3 secondary outcomes
Lower extremity flexibility
Time frame: 2 weeks
Menstrual symptoms
Time frame: 2 weeks
Depression, anxiety and stress symptoms
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Primary Dysmenorrhea
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Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
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Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
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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
Dysmenorrhea Primary
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Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
Primary Dysmenorrhea, Menstrual Pain
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.
Kubra Alpay principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dysmenorrhea, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 5 inclusion and 9 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 1 Oct 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 Turkey (Türkiye). 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 Kubra Alpay, PhD (+902124012600 ext. 4638, kubraalpay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: 2 weeks). The study lists 4 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 1 Oct 2024.