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

Last updated: March 4, 2025
Sponsor: Artvin Coruh University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Female Hormonal Deficiencies/abnormalities

Severe Premenstrual Symptom

Treatment

Exercise Treatment

Clinical Study ID

NCT06835036
MCID
  • Ages 18-35
  • Female

Study 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).

Eligibility Criteria

Inclusion

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 severepain),

  • Patients aged 18-35 years (when PD becomes more prevalent),

  • Regular menstrual cycle with a duration of 28±7 days,

  • Nulliparity.

Exclusion

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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Exercise Treatment
Phase:
Study Start date:
February 15, 2025
Estimated Completion Date:
May 15, 2025

Study Description

100 PwPD will receive functional exercises three times a week for three menstrual cycles. Patients will be assessed on the most painful days of the first (baseline), second, and third menstrual cycles. The receiver operating characteristics (ROC) method and Gamma coefficient analysis will be applied to determine the responsiveness.

Connect with a study center

  • Zeynep Yıldız Kızkın

    Artvin, 08000
    Turkey

    Active - Recruiting

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