Primary Dysmenorrhea Clinical Trial
Official title:
Evaluation of Pain and Physical Fitness in Primary Dysmenorrhea
NCT number | NCT06401226 |
Other study ID # | KA24-1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2023 |
Est. completion date | September 2024 |
The aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization in primary dysmenorrhea.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | September 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 25 Years |
Eligibility | Inclusion Criteria: - Between the ages of 18-25 - Body mass index of 18-25 kg/m2 - Having a regular menstrual cycle (28±7 days) - For the PD Group; pain level >5 according to VAS during menstruation - For the Control Group; having a VAS score of 5 or less Exclusion Criteria: - Having given birth before - Using an intrauterine device - Having a health problem that causes chronic pain - Having a diagnosis of neurological, orthopedic, vestibular, rheumatological disorder - Being diagnosed with a gynecological or pelvic disorder such as endometriosis, ovarian cyst - Having a history of abdominal or gynecological surgery within the last year - Being on oral contraceptive use/hormonal therapy or antidepressant treatment - Having used painkillers 12 hours before the evaluation - Participating in a regular exercise program |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain assessment | Pain assessment will be evaluated with a visual analog scale. Subjects will be asked to mark the intensity of the pain they feel on a 10 cm line, where "0" means no pain and "10" means very severe pain. | 2 weeks | |
Primary | Core stability | A pressurized biofeedback device will be used to evaluate core stability. The device will initially be set to 70 mmHg pressure and changes in pressure will be recorded for analysis at the end of the evaluation. | 2 weeks | |
Primary | Lower extremity muscle strength | A 30-second sit to stand test will be used to evaluate the individual's lower extremity muscle strength and functional capacity. The number of repetitions performed in 30 seconds is recorded. | 2 weeks | |
Primary | Balance | Biodex Balance System (Biodex Medical Systems, Inc. USA) will be used in the dynamic postural stability test and sensory integration of balance clinical test evaluations. | 2 weeks | |
Secondary | Lower extremity flexibility | Lower extremity flexibility will be performed with a sit-and-reach test. Evaluation will be carried out by measuring the distance between the platform and the hands of the subjects at the last point they can reach while reaching forward with their hands. | 2 weeks | |
Secondary | Menstrual symptoms | Menstrual Symptom Questionnaire will be used to evaluate pain and symptoms related to menstruation. The scale score is calculated by taking the total score average of the items in the scale. An increase in the average score indicates an increase in the severity of menstrual symptoms. | 2 weeks | |
Secondary | Depression, anxiety and stress symptoms | Depression Anxiety Stress Scale will be used. The scale consists of 3 sub-dimensions. Higher scores indicate an increase of severity of symptoms for each sub-dimensions. | 2 weeks |
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