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

NCT07341685 | Not Yet Recruiting

• 1 other identifier: Dismenore-35
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Primary Dysmenorrhea

Keywords

Dysmenorrhea; Joint Mobility; Physical Activity

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Baseline

Study Arms (2)

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.

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.

Other: Observational Assessment

Interventions

Observational Assessment OTHER

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.

Control Group; Primary Dysmenorrhea Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Only participants experiencing menstrual pain will be included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Democracy University: lead

MeSH Terms

Conditions

Dysmenorrhea; Motor Activity

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Betül Taşpınar, Prof.Dr

CONTACT

+905066804426; betul.taspinar@idu.edu.tr

Ferruh Taşpınar, Prof.Dr

CONTACT

+905426853877; ferruh.taspinar@idu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share