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Completed

NCT Number: NCT06835036

More Than Just p-Values: MCID for the VAS, MSQ and FEMD 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).

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Key information

Conditions

Primary Dysmenorrhea Dysmenorrhea Menstrual Discomfort Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Yıldız Kızkın

Artvin, 08000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise treatment

Other

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Artvin Coruh University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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