Clinical trial NCT06401226: Pain and Physical Fitness in Primary Dysmenorrhea
Official title: Evaluation of Pain and Physical Fitness in Primary Dysmenorrhea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Dysmenorrhea
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The primary dysmenorrhea group will consist of cases diagnosed by a gynecologist. The Control Group will consist of healthy women who meet inclusion criteria.

Brief summary: The aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization in primary dysmenorrhea.

Detailed description: Primary dysmenorrhea (PD) is a condition that occurs just before or during menstruation and is accompanied by cramp-like pain in the lower abdomen, without any pelvic pathology. Pain usually begins just before or during menstruation and ends within 12-72 hours. Most women with PD describe their menstrual pain as moderate to severe, which significantly affects their activities of daily living and school and work performance.

In PD, functions and activities of daily living are also affected due to pain and other hormonal changes. Studies have reported that musculoskeletal problems such as decreased spinal mobility, pelvic stability and postural control are observed in women with dysmenorrhea.

The aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization during the menstruation and on a non-menstrual day of the cycle, in primary dysmenorrhea.

Eligibility criteria: 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

Primary outcomes:
measure: Pain assessment
timeFrame: 2 weeks
measure: Core stability
timeFrame: 2 weeks
measure: Lower extremity muscle strength
timeFrame: 2 weeks
measure: Balance
timeFrame: 2 weeks
Secondary outcomes:
measure: Lower extremity flexibility
timeFrame: 2 weeks
measure: Menstrual symptoms
timeFrame: 2 weeks
measure: Depression, anxiety and stress symptoms
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Kubra Alpay
role: PRINCIPAL_INVESTIGATOR
References: