Primary DysmenorrheaNCT07341685
Comparison of Pain, Physical, and Psychosocial Parameters in Women With and Without Primary Dysmenorrhea
A study testing Observational Assessment in people with Primary Dysmenorrhea, run by Izmir Democracy University.
Trial summary
Dysmenorrhea is a common gynecological condition that negatively affects women's physical, psychological, and social well-being. Primary dysmenorrhea (PD) has been associated with reduced pain thresholds in various body regions; however, evidence regarding its relationship with joint mobility, respiratory muscle… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Observational Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 15 Feb 2027
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between 18 and 35 years of age
- Have a history of menstrual pain since the first few years after menarche
- Have a menstrual pain intensity of 4 or higher on the VAS in the last 6 months
- Have no pelvic or uterine pathology (e.g., cysts, infections, fibroids)
- Have a regular menstrual cycle
- Be willing to voluntarily participate in the study
Who cannot join
- Having a neurological, orthopedic, rheumatologic, cardiac, or pulmonary disease
- Being pregnant or suspected of pregnancy
- Having given birth
- Having undergone abdominal, pelvic, or spinal surgery within the past year
- Having a malignant disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Women With andWithout Primary Dysmenorrhea in Terms of Pain Threshold, Joint Mobility, PhysicalActivity Habit Level, Respiratory Muscle Strength, Menstruation Attitudes andDepressive Symptoms
Dysmenorrhea is a common gynecological condition that negatively affects women's physical, psychological, and social well-being. Primary dysmenorrhea (PD) has been associated with reduced pain thresholds in various body regions; however, evidence regarding its relationship with joint mobility, respiratory muscle strength, and psychosocial factors remains limited. In addition, the influence of menstrual attitudes, physical activity habits, and depressive symptoms in women with PD has not been sufficiently explored. Therefore, this study aims to compare women with and without primary dysmenorrhea in terms of pain threshold, joint mobility, physical activity level, respiratory muscle strength, menstrual attitudes, and depressive symptoms. Identifying the parameters affected by PD is essential for developing effective management strategies and may contribute to increased awareness and improved clinical approaches for primary dysmenorrhea.
Read the detailed description
Dysmenorrhea is a very common gynecological problem among women during the menstrual period and is defined as "painful menstruation." The pain is most commonly experienced in the abdominal and lumbar regions and is typically described as cramping and colicky in nature. Symptoms such as nausea, vomiting, headache, and leg pain may accompany the pain in dysmenorrhea. Dysmenorrhea leads to decreased work productivity, increased tension in social life, and absenteeism from school or work. Dysmenorrhea is classified into two types: primary and secondary.
In women with primary dysmenorrhea (PD), pressure, heat, and electrical pain thresholds in the abdominal, paravertebral, and extremity regions have been shown to decrease during the menstrual phase. However, research on painful pelvic floor regions in women with PD is still in its early stages. There is very limited published data in the literature addressing the optimal management of women with hypermobility and abnormal uterine bleeding. Therefore, it is necessary to determine the relationship between joint mobility and PD. Similarly, no studies have been found examining PD and respiratory muscle strength. On the other hand, positive or negative beliefs related to menstruation and cultural factors may also influence menstrual attitudes. Although a positive relationship between dysmenorrhea and depression is assumed, the evidence remains controversial and limited.
In light of this information, it is of interest to investigate how all these parameters differ in women with PD compared to women without PD. Therefore, the aim of this study is to compare women with and without primary dysmenorrhea in terms of pain threshold, joint mobility, physical activity level, respiratory muscle strength, menstrual attitudes, and depressive symptoms. Identifying which parameters are affected in PD is important for clinicians and researchers in order to determine effective management strategies for primary dysmenorrhea. Thus, it is believed that this study will contribute to the literature by increasing awareness on this topic.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Observational Assessment
- Keywords
- Dysmenorrhea, Joint Mobility, Physical Activity
- Medical subject headings
- Dysmenorrhea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational AssessmentOther
This study does not involve any therapeutic intervention. Participants undergo observational, non-invasive assessments including pain threshold measurement, joint mobility evaluation, physical activity level assessment, respiratory muscle strength testing, menstrual attitude questionnaires, and depressive symptom evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Primary Dysmenorrhea Group | Other | Female participants diagnosed with primary dysmenorrhea. Pain threshold, joint mobility, physical activity level, respiratory muscle strength, menstrual attitudes, and depressive symptoms are assessed. Receives: Other: Observational Assessment |
| Control Group | Other | Female participants without primary dysmenorrhea. Pain threshold, joint mobility, physical activity level, respiratory muscle strength, menstrual attitudes, and depressive symptoms are assessed. Receives: Other: Observational Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain Threshold
In this study, participants' pressure pain threshold (PPT) will be assessed. A Wagner digital algometer (Wagner Instruments) will be used to evaluate PPT. Participants will be seated on an adjustable chair with their feet fully supported on the floor and their knees flexed at 90 degrees. For PPT assessment, the algometer will be applied perpendicular (90° angle) to the measurement site.
Measurements will be performed bilaterally at the midpoint of the upper trapezius muscle, 7 cm lateral to the umbilicus on both the right and left sides, at the midpoint of the paravertebral muscles at the level of the fifth lumbar vertebra, and at the midpoint of the thigh. Each measurement will be repeated three times for each site. A minimum interval of 30 seconds will be allowed between repeated measurements at the same site. The value at which pain is first perceived will be recorded, and the mean of the three measurements will be calculated for each site.
Measured: Baseline
Assessment of Joint Mobility
Joint mobility will be assessed using the Beighton criteria. The Beighton score is one of the most commonly used methods for the diagnosis of joint hypermobility. It is a simple scoring system consisting of five maneuvers with a total score of nine points. The first four maneuvers are assessed bilaterally in all extremities, with one point awarded for each successfully performed movement. The fifth maneuver is scored as one point. A total score of at least 4 out of 9 (≥4/9) is required to indicate joint hypermobility.
Measured: Baseline
Assessment of Physical Activity Level
The International Physical Activity Questionnaire (IPAQ) was developed by Craig et al. to assess individuals' physical activity levels. The validity and reliability of the Turkish version were established by Öztürk et al. The questionnaire is available in two forms: long and short. In this study, the short form of the IPAQ will be used. The short form consists of seven items and provides information on the time spent in walking, moderate-intensity, and vigorous-intensity physical activities. Time spent sitting is assessed as a separate item.
The total score of the short form is calculated by summing the duration (minutes) and frequency (days) of walking, moderate-intensity, and vigorous-intensity activities. Based on these calculations, a score expressed in MET-minutes is obtained. Energy expenditure for physical activities is calculated using MET-minute scores, and participants are classified according to the numerical values derived from the total score.
Measured: Baseline
Assessment of Respiratory Muscle Strength
Respiratory muscle strength will be assessed using the Cosmed Pony FX spirometer. Voluntary measurements of inspiratory and expiratory muscle strength will be performed with a portable mouth pressure device following ATS/ERS guidelines. Maximal static inspiratory pressure (MIP) will be measured during a brief, forceful inspiratory effort from residual volume (Müller maneuver), and maximal static expiratory pressure (MEP) will be measured during maximal expiration at total lung capacity (Valsalva maneuver). Measurements will be repeated until valid values are obtained. If consecutive measurements differ by more than 5% or 5 cmH₂O, the test will be repeated. The highest value will be used for analysis, and reference equations by Evans and Whitelaw will be applied.
Measured: Baseline
Assessment of Menstrual Attitudes
The Menstrual Attitude Questionnaire (MAQ) was developed based on the theory that menstrual attitudes are multidimensional, encompassing both positive and negative perspectives, and that expectations related to physiological and emotional symptoms before or during menstruation may influence behaviors exhibited during this period. The MAQ is a self-administered, easy-to-use questionnaire consisting of 33 items designed to assess positive and negative attitudes toward menstruation.
The questionnaire includes five subscales: (1) menstruation as a debilitating event (12 items), (2) menstruation as a bothersome event (6 items), (3) menstruation as a natural event (5 items), (4) anticipation/prediction of the onset of menstruation (5 items), and (5) denial of the effects of menstruation (7 items). Items are rated on a 5-point Likert scale ranging from 1 to 5. Higher scores obtained from the subscales indicate a more positive attitude toward menstruation.
Measured: Baseline
Assessment of Depressive Symptoms
Depressive symptoms will be evaluated using the Beck Depression Inventory (BDI). The BDI was developed by combining frequently observed symptoms and attitudes specific to depression, along with commonly exhibited behaviors. The questionnaire has no time limit and can be completed in approximately 10-15 minutes. It consists of 21 symptom categories, with each item rated on a scale from 0 to 3 according to symptom severity.
Total scores are interpreted as follows: 0-9 indicating no or minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Feb 2027 (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.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- comparing women with primary dysmenorrhea to women without dysmenorrhea. Measurements of pain threshold, joint mobility, physical activity level, respiratory muscle strength, menstrual attitudes, and depressive symptoms are collected in a single visit.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Taşpınar, Izmir Democracy University
- Investigators
- Ayşe Sezgi Kızılırmak Karataş, Asst.Prof, Principal investigator, Izmir Democracy UniversityBüşra Aydın, std., Principal investigator, Izmir Democracy UniversityÖykü Dündar, std., Principal investigator, Izmir Democracy UniversityTurna Sürmen, std., Principal investigator, Izmir Democracy UniversityNalan Anık, std., Principal investigator, Izmir Democracy UniversityKader İliman, std., Principal investigator, Izmir Democracy UniversityFadıma Kılıç, std., Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341685
- Sponsor's protocol ID
- Dismenore-35
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 14 Jan 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Women With andWithout Primary Dysmenorrhea in Terms of Pain Threshold, Joint Mobility, PhysicalActivity Habit Level, Respiratory Muscle Strength, Menstruation Attitudes andDepressive Symptoms
- ClinicalTrials.gov ID
- NCT07341685
- Acronym / sponsor ID
- Dismenore-35
- Conditions
- Primary Dysmenorrhea
- Keywords
- Dysmenorrhea, Joint Mobility, Physical Activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 14 Jan 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.
Dysmenorrhea is a common gynecological condition that negatively affects women's physical, psychological, and social well-being. Primary dysmenorrhea (PD) has been associated with reduced pain thresholds in various body regions; however, evidence regarding its relationship with joint mobility, respiratory muscle strength, and psychosocial factors remains limited. In addition, the influence of menstrual attitudes, physical activity habits, and depressive symptoms in women with PD has not been sufficiently explored. Therefore, this study aims to compare women with and without primary dysmenorrhea in terms of pain threshold, joint mobility, physical activity level, respiratory muscle strength, menstrual attitudes, and depressive symptoms. Identifying the parameters affected by PD is essential for developing effective management strategies and may contribute to increased awareness and improved clinical approaches for primary dysmenorrhea.
Detailed description
Dysmenorrhea is a very common gynecological problem among women during the menstrual period and is defined as "painful menstruation." The pain is most commonly experienced in the abdominal and lumbar regions and is typically described as cramping and colicky in nature. Symptoms such as nausea, vomiting, headache, and leg pain may accompany the pain in dysmenorrhea. Dysmenorrhea leads to decreased work productivity, increased tension in social life, and absenteeism from school or work. Dysmenorrhea is classified into two types: primary and secondary.
In women with primary dysmenorrhea (PD), pressure, heat, and electrical pain thresholds in the abdominal, paravertebral, and extremity regions have been shown to decrease during the menstrual phase. However, research on painful pelvic floor regions in women with PD is still in its early stages. There is very limited published data in the literature addressing the optimal management of women with hypermobility and abnormal uterine bleeding. Therefore, it is necessary to determine the relationship between joint mobility and PD. Similarly, no studies have been found examining PD and respiratory muscle strength. On the other hand, positive or negative beliefs related to menstruation and cultural factors may also influence menstrual attitudes. Although a positive relationship between dysmenorrhea and depression is assumed, the evidence remains controversial and limited.
In light of this information, it is of interest to investigate how all these parameters differ in women with PD compared to women without PD. Therefore, the aim of this study is to compare women with and without primary dysmenorrhea in terms of pain threshold, joint mobility, physical activity level, respiratory muscle strength, menstrual attitudes, and depressive symptoms. Identifying which parameters are affected in PD is important for clinicians and researchers in order to determine effective management strategies for primary dysmenorrhea. Thus, it is believed that this study will contribute to the literature by increasing awareness on this topic.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparing women with primary dysmenorrhea to women without dysmenorrhea. Measurements of pain threshold, joint mobility, physical activity level, respiratory muscle strength, menstrual attitudes, and depressive symptoms are collected in a single visit.
| Arm | Type | Receives |
|---|---|---|
| Primary Dysmenorrhea Group | Other | Other: Observational AssessmentFemale participants diagnosed with primary dysmenorrhea. Pain threshold, joint mobility, physical activity level, respiratory muscle strength, menstrual attitudes, and depressive symptoms are assessed. |
| Control Group | Other | Other: Observational AssessmentFemale participants without primary dysmenorrhea. Pain threshold, joint mobility, physical activity level, respiratory muscle strength, menstrual attitudes, and depressive symptoms are assessed. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Be between 18 and 35 years of age
- Have a history of menstrual pain since the first few years after menarche
- Have a menstrual pain intensity of 4 or higher on the VAS in the last 6 months
- Have no pelvic or uterine pathology (e.g., cysts, infections, fibroids)
- Have a regular menstrual cycle
Key exclusion criteria (5 listed)
- Having a neurological, orthopedic, rheumatologic, cardiac, or pulmonary disease
- Being pregnant or suspected of pregnancy
- Having given birth
- Having undergone abdominal, pelvic, or spinal surgery within the past year
- Having a malignant disease
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 |
|---|---|---|
| Observational AssessmentThis study does not involve any therapeutic intervention. Participants undergo observational, non-invasive assessments including pain threshold measurement, joint mobility evaluation, physical activity level assessment, respiratory muscle strength testing, menstrual attitude questionnaires, and depressive symptom evaluation. | Other | Control Group, Primary Dysmenorrhea Group |
Primary outcome
Assessment of Pain Threshold
Time frame: Baseline
In this study, participants' pressure pain threshold (PPT) will be assessed. A Wagner digital algometer (Wagner Instruments) will be used to evaluate PPT. Participants will be seated on an adjustable chair with their feet fully supported on the floor and their knees flexed at 90 degrees. For PPT assessment, the algometer will be applied perpendicular (90° angle) to the measurement site. Measurements will be performed bilaterally at the midpoint of the upper trapezius muscle, 7 cm lateral to the umbilicus on both the right and left sides, at the midpoint of the paravertebral muscles at the level of the fifth lumbar vertebra, and at the midpoint of the thigh. Each measurement will be repeated three times for each site. A minimum interval of 30 seconds will be allowed between repeated measurements at the same site. The value at which pain is first perceived will be recorded, and the mean of the three measurements will be calculated for each site.
Assessment of Joint Mobility
Time frame: Baseline
Joint mobility will be assessed using the Beighton criteria. The Beighton score is one of the most commonly used methods for the diagnosis of joint hypermobility. It is a simple scoring system consisting of five maneuvers with a total score of nine points. The first four maneuvers are assessed bilaterally in all extremities, with one point awarded for each successfully performed movement. The fifth maneuver is scored as one point. A total score of at least 4 out of 9 (≥4/9) is required to indicate joint hypermobility.
Assessment of Physical Activity Level
Time frame: Baseline
The International Physical Activity Questionnaire (IPAQ) was developed by Craig et al. to assess individuals' physical activity levels. The validity and reliability of the Turkish version were established by Öztürk et al. The questionnaire is available in two forms: long and short. In this study, the short form of the IPAQ will be used. The short form consists of seven items and provides information on the time spent in walking, moderate-intensity, and vigorous-intensity physical activities. Time spent sitting is assessed as a separate item. The total score of the short form is calculated by summing the duration (minutes) and frequency (days) of walking, moderate-intensity, and vigorous-intensity activities. Based on these calculations, a score expressed in MET-minutes is obtained. Energy expenditure for physical activities is calculated using MET-minute scores, and participants are classified according to the numerical values derived from the total score.
Assessment of Respiratory Muscle Strength
Time frame: Baseline
Respiratory muscle strength will be assessed using the Cosmed Pony FX spirometer. Voluntary measurements of inspiratory and expiratory muscle strength will be performed with a portable mouth pressure device following ATS/ERS guidelines. Maximal static inspiratory pressure (MIP) will be measured during a brief, forceful inspiratory effort from residual volume (Müller maneuver), and maximal static expiratory pressure (MEP) will be measured during maximal expiration at total lung capacity (Valsalva maneuver). Measurements will be repeated until valid values are obtained. If consecutive measurements differ by more than 5% or 5 cmH₂O, the test will be repeated. The highest value will be used for analysis, and reference equations by Evans and Whitelaw will be applied.
Assessment of Menstrual Attitudes
Time frame: Baseline
The Menstrual Attitude Questionnaire (MAQ) was developed based on the theory that menstrual attitudes are multidimensional, encompassing both positive and negative perspectives, and that expectations related to physiological and emotional symptoms before or during menstruation may influence behaviors exhibited during this period. The MAQ is a self-administered, easy-to-use questionnaire consisting of 33 items designed to assess positive and negative attitudes toward menstruation. The questionnaire includes five subscales: (1) menstruation as a debilitating event (12 items), (2) menstruation as a bothersome event (6 items), (3) menstruation as a natural event (5 items), (4) anticipation/prediction of the onset of menstruation (5 items), and (5) denial of the effects of menstruation (7 items). Items are rated on a 5-point Likert scale ranging from 1 to 5. Higher scores obtained from the subscales indicate a more positive attitude toward menstruation.
Assessment of Depressive Symptoms
Time frame: Baseline
Depressive symptoms will be evaluated using the Beck Depression Inventory (BDI). The BDI was developed by combining frequently observed symptoms and attitudes specific to depression, along with commonly exhibited behaviors. The questionnaire has no time limit and can be completed in approximately 10-15 minutes. It consists of 21 symptom categories, with each item rated on a scale from 0 to 3 according to symptom severity. Total scores are interpreted as follows: 0-9 indicating no or minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.
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 14 Jan 2026.
- 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.
Ayşe Sezgi Kızılırmak Karataş, Asst.Prof principal investigator
Izmir Democracy University
Büşra Aydın, std. principal investigator
Izmir Democracy University
Öykü Dündar, std. principal investigator
Izmir Democracy University
Questions about this trial
What is this clinical trial studying?
A study testing Observational Assessment in people with Primary Dysmenorrhea, run by Izmir Democracy University.
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 6 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: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Betül Taşpınar, Prof.Dr (+905066804426, betul.taspinar@idu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Pain Threshold (time frame: Baseline). The study lists 6 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 14 Jan 2026.