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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorIzmir Democracy University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Observational Assessment

    Other intervention

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Primary Dysmenorrhea GroupOther 1 intervention
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

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.

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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