Comparison of Pain, Physical, and Psychosocial Parameters in Women With and Without Primary Dysmenorrhea

January 6, 2026 updated by: Betül Taşpınar, Izmir Democracy University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Primary Dysmenorrhea Group
Female participants diagnosed with primary dysmenorrhea. Pain threshold, joint mobility, physical activity level, respiratory muscle strength, menstrual attitudes, and depressive symptoms are assessed.
Other: Observational Assessment
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.
Other: Control Group
Female participants without primary dysmenorrhea. Pain threshold, joint mobility, physical activity level, respiratory muscle strength, menstrual attitudes, and depressive symptoms are assessed.
Other: Observational Assessment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Democracy University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ayşe Sezgi Kızılırmak Karataş, Asst.Prof, Izmir Democracy University
  • Principal Investigator: Büşra Aydın, std., Izmir Democracy University
  • Principal Investigator: Öykü Dündar, std., Izmir Democracy University
  • Principal Investigator: Turna Sürmen, std., Izmir Democracy University
  • Principal Investigator: Nalan Anık, std., Izmir Democracy University
  • Principal Investigator: Kader İliman, std., Izmir Democracy University
  • Principal Investigator: Fadıma Kılıç, std., Izmir Democracy University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dismenore-35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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