Determining important differences in pain measurement for women with menstrual discomfort
More Than Just p-Values: Minimal Clinically Important Difference for the Visual Analog Scale, Menstrual Symptom Questionnaire and Functional and Emotional Measure of Dysmenorrhea in Patients With Primary Dysmenorrhea
NA · Artvin Coruh University · NCT06835036
This study is trying to find out how much change in pain levels is meaningful for women with menstrual cramps by using different pain measurement tools during their periods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Artvin Coruh University (other) |
| Locations | 1 site (Artvin) |
| Trial ID | NCT06835036 on ClinicalTrials.gov |
What this trial studies
This study aims to identify the Minimal Clinically Important Difference (MCID) for pain assessment tools in women suffering from primary dysmenorrhea. A total of 100 participants will engage in functional exercises three times a week over three menstrual cycles. Pain levels will be evaluated on the most painful days of each cycle using the Visual Analog Scale (VAS), Menstrual Symptom Questionnaire (MSQ), and Functional and Emotional Measure of Dysmenorrhea (FEMD). The study will utilize receiver operating characteristics (ROC) and Gamma coefficient analysis to assess the responsiveness of these measures.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-35 who experience moderate to severe menstrual pain and have a diagnosis of primary dysmenorrhea.
Not a fit: Patients with secondary dysmenorrhea or those with a history of chronic urogenital infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer benchmarks for assessing pain relief in women with primary dysmenorrhea, leading to improved treatment strategies.
How similar studies have performed: Other studies have successfully utilized similar methodologies to assess pain measurement tools, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Artvin
- Zeynep Yıldız Kızkın — Artvin, Turkey (RECRUITING)
Study contacts
- Principal investigator: Zeynep Yıldız Kızkın, Dr. — Artvin Coruh University
- Study coordinator: Zeynep Yıldız Kızkın, Dr.
- Email: pt.zeynepyildiz@gmail.com
- Phone: 5346945085
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Dysmenorrhea, Pain, Menstrual Discomfort, Dysmenorrhea, Menstruation, Visual Analog Scale, Minimal Clinically Important Difference, ROC Curve