CompletedNot Applicable

Core Muscle Strength in Women with Primary Dysmenorrhoea

Turkey (Türkiye)54 participantsStarted 2024-01-15

Plain-language summary

The aim of this study is to compare core muscle strength, core muscle activations, and pelvic tilt angles in women with and without Primary Dysmenorrhea (PD).

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must meet the following criteria to be included in the study: Age between 18 and 35 years Diagnosed with Primary Dysmenorrhea (PD) according to the PD consensus criteria, which include: Presence of menstrual pain within the first few years after menarche A Visual Analog Scale (VAS) pain score of 4 or higher in the last six months No pelvic pathology Having a regular menstrual cycle (21-35 days) No uterine disorders Exclusion Criteria: The sample size for the study was determined using the G\*Power software (latest version 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). Since our study consists of two groups (participants with and without Primary Dysmenorrhea), the power analysis was conducted using the "Means: Difference between two independent means (two groups)" method. Based on similar studies, an effect size of d = 0.726 was used for the calculation. With a statistical power of 80% and a significance level of 5% (α = 0.05), the minimum required sample size was determined to be at least 25 participants per group, totaling 50 participants.Pregnancy or suspicion of pregnancy Active sexual life History of childbirth Use of an intrauterine device (IUD) History of surgery involving the abdomen, spine, or pelvic region within the last year Diagnosis of secondary dysmenorrhea Body mass index (BMI) of 30 or higher

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analog Scale (VAS)

Timeframe: 10 minutes

Menstrual Symptom Scale

Timeframe: 15 minutes

Core Strength Test

Timeframe: 20 minutes

Measurement of Core Muscle Strength Using Surface EMG

Timeframe: 30 minutes

Trial details

NCT IDNCT06854900

SponsorDerya Azim

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-15

View on ClinicalTrials.gov More Pelvic Floor Muscle Weakness trials