An interventional study of Observational Assessment in Primary Dysmenorrhea, sponsored by Izmir Democracy University. Not yet recruiting. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Izmir Democracy University · Not applicable, Interventional, and Other
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.
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.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 70 is above the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Izmir Democracy University is the lead sponsor of 78 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
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
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.
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
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
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
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
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.
Time frame: 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.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Aug 2026, 6 months later.
Of 178 non-industry interventional studies with no phase under Dysmenorrhea, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 6 months is below that.
Counting every sponsor, half of 188 studies reached it within 8 months; a quarter within 3 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Izmir Democracy University