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

August 30, 2025 updated by: Zeynep Yıldız Kızkın, Artvin Coruh University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Treatment
Each patient will receive a treatment protocol consisting of warm-up and functional exercises.
Other: Exercise Treatment
In this study, a functional exercise programme will be performed 3 days a week for 8 weeks in three cycles as previously recommended. This programme consisted of a 5-minute warm-up and a 45-minute exercise phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Baseline (On the most painful day of the menstrual cycle before the intervention)
Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky).
Baseline (On the most painful day of the menstrual cycle before the intervention)
Pain Intensity
Time Frame: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky).
After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Pain Intensity
Time Frame: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky).
After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstrual Symptom Questionnaire (MSQ)
Time Frame: Baseline (On the most painful day of the menstrual cycle before the intervention)
The Likert scale consists of 22 items, with responses rated on a 5-point range from 1 (never) to 5 (always). The scale includes three components: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The MSQ score is the mean value of all items in the scale. Increasing scores reflect more menstrual symptoms.
Baseline (On the most painful day of the menstrual cycle before the intervention)
Menstrual Symptom Questionnaire (MSQ)
Time Frame: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
The Likert scale consists of 22 items, with responses rated on a 5-point range from 1 (never) to 5 (always). The scale includes three components: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The MSQ score is the mean value of all items in the scale. Increasing scores reflect more menstrual symptoms.
After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Menstrual Symptom Questionnaire (MSQ)
Time Frame: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
The Likert scale consists of 22 items, with responses rated on a 5-point range from 1 (never) to 5 (always). The scale includes three components: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The MSQ score is the mean value of all items in the scale. Increasing scores reflect more menstrual symptoms.
After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
Functional and Emotional Measure of Dysmenorrhea (FEMD)
Time Frame: Baseline (On the most painful day of the menstrual cycle before the intervention)
The FEMD is a 14-item measurement tool that evaluates the functional and emotional aspects of dysmenorrhea using a 5-point Likert-type scale. The total scores on this scale range from 14 to 70, with higher scores indicating a more significant functional and emotional impact of dysmenorrhea on an individual.
Baseline (On the most painful day of the menstrual cycle before the intervention)
Functional and Emotional Measure of Dysmenorrhea (FEMD)
Time Frame: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
The FEMD is a 14-item measurement tool that evaluates the functional and emotional aspects of dysmenorrhea using a 5-point Likert-type scale. The total scores on this scale range from 14 to 70, with higher scores indicating a more significant functional and emotional impact of dysmenorrhea on an individual.
After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Functional and Emotional Measure of Dysmenorrhea (FEMD)
Time Frame: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
The FEMD is a 14-item measurement tool that evaluates the functional and emotional aspects of dysmenorrhea using a 5-point Likert-type scale. The total scores on this scale range from 14 to 70, with higher scores indicating a more significant functional and emotional impact of dysmenorrhea on an individual.
After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
Global Rating Change (GRC)
Time Frame: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
The GRC comprised seven responses, ranging from 1 to 7, indicating "very much better," "much better," "slightly better," "no change," "slightly worse," "much worse," and "very much worse," respectively.
After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Global Rating Change (GRC)
Time Frame: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
The GRC comprised seven responses, ranging from 1 to 7, indicating "very much better," "much better," "slightly better," "no change," "slightly worse," "much worse," and "very much worse," respectively.
After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artvin Coruh University

Investigators

  • Principal Investigator: Zeynep Yıldız Kızkın, Dr., Artvin Çoruh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2025

Primary Completion (Actual)

July 3, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 19, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

August 30, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Exercise Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe