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

Artvin Coruh University

Status: Enrolling

Conditions: Primary Dysmenorrhea; Menstrual Discomfort; Pain

Treatments: Other: Exercise Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06835036

MCID

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Exercise Treatment

Experimental group

Description:

Each patient will receive a treatment protocol consisting of warm-up and functional exercises.

Treatment:

Other: Exercise Treatment