CompletedNot Applicable

More Than Just p-Values: MCID for the VAS, MSQ and FEMD in Patients With Primary Dysmenorrhea

Turkey (Türkiye)100 participantsStarted 2025-02-15

Plain-language summary

The aim of this study is to determine the Minimal Clinically Important Difference (MCID) for the Visual Analog Scale (VAS), Menstrual Symptom Questionnaire (MSQ), and Functional and Emotional Measure of Dysmenorrhea (FEMD) in patients with primary dysmenorrhea (PwPD).

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: * Diagnosis of PD according to the "No. 345-Primary Dysmenorrhea Consensus Guideline", * Pain level of three or more according to VAS during activity (moderate to severe pain), * Patients aged 18-35 years (when PD becomes more prevalent), * Regular menstrual cycle with a duration of 28±7 days, * Nulliparity. Exclusion Criteria: * Historical background of chronic urogenital infections or drug use, * Pregnancy, * Secondary dysmenorrhoea caused by gynaecological conditions such as endometriosis, adenomyosis and uterine fibroids.

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

Pain Intensity

Timeframe: Baseline (On the most painful day of the menstrual cycle before the intervention)

Pain Intensity

Timeframe: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)

Pain Intensity

Timeframe: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)

Trial details

NCT IDNCT06835036

SponsorArtvin Coruh University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-03

View on ClinicalTrials.gov More Primary Dysmenorrhea trials

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.

What they're measuring

Pain Intensity

Timeframe: Baseline (On the most painful day of the menstrual cycle before the intervention)

Pain Intensity

Timeframe: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)

Pain Intensity

Timeframe: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)