Clinical trial NCT06835036: More Than Just p-Values: MCID for the VAS, MSQ and FEMD in Patients With Primary Dysmenorrhea
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Dysmenorrhea
Pain
Menstrual Discomfort
Keywords: Dysmenorrhea
Menstruation
Visual Analog Scale
Minimal Clinically Important Difference
ROC Curve
Lead sponsor: Artvin Coruh University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In this prospective study, one treatment group was formed to receive exercise treatment.
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Pain Intensity
timeFrame: Baseline (On the most painful day of the menstrual cycle before the intervention)
measure: Pain Intensity
timeFrame: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
measure: Pain Intensity
timeFrame: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
Secondary outcomes:
measure: Menstrual Symptom Questionnaire (MSQ)
timeFrame: Baseline (On the most painful day of the menstrual cycle before the intervention)
measure: Menstrual Symptom Questionnaire (MSQ)
timeFrame: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
measure: Menstrual Symptom Questionnaire (MSQ)
timeFrame: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
measure: Functional and Emotional Measure of Dysmenorrhea (FEMD)
timeFrame: Baseline (On the most painful day of the menstrual cycle before the intervention)
measure: Functional and Emotional Measure of Dysmenorrhea (FEMD)
timeFrame: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
measure: Functional and Emotional Measure of Dysmenorrhea (FEMD)
timeFrame: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
measure: Global Rating Change (GRC)
timeFrame: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
measure: Global Rating Change (GRC)
timeFrame: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
Other outcomes:
Locations:
city: Artvin
country: Turkey
facility: Zeynep Yıldız Kızkın
Study officials:
affiliation: Artvin Coruh University
name: Zeynep Yıldız Kızkın, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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