A Two-stage Translation of the Chinese Version Menstrual Distress Questionnaire

A Two-stage Translation of the Chinese Version Menstrual Distress Questionnaire: a Physical, Psychological, and Behavior Study in Taiwan

This study attempted to do the two-stage design of the translation of the MDQC (Menstrual Distress Questionnaire Form C-Cycle) Chinese version, and to do the validity and reliability test.

Study Overview

• Status: Completed
• Conditions: Non-disease State
• Intervention / Treatment: Other: questionnaire

Detailed Description

Premenstrual syndrome is defined as recurrent moderate physical, psychological, behavior symptoms that occur during the luteal phase of menses and resolve with menstruation. It affects 20 to 32 percent of premenopausal women.

A diagnosis of PMS consists of determining the timing of the symptoms in relation to menses, meaningful change between post- and premenstrual symptom severity, and a clinically significant severity of the symptoms. The ICD-10 requires only one distressing symptom for a diagnosis of PMS. The American College of Obstetricians and Gynecologists (ACOG) diagnosis is that it occurs 5 days before menses and remit within 4 days of onset of menses no recurrence at least until day 13 of the cycle. A differential diagnosis to distinguish PMS from other medical and psychiatric conditions is important for appropriate treatment. No hormone or laboratory test indicates a PMS diagnosis. The current diagnostic standard requires confirmation of subjective symptom reports by prospective daily diaries. The Menstrual Distress Questionnaire (MDQ) is a method for measuring perimenstrual symptoms. It is a 46-item self-report inventory for use in the assessment of physical or psychological symptoms that occur in the premenstrual, menstrual, or intermenstrual phases. There are two forms of the MDQ: form C (Cycle) and form T (Today). Form C of the MDQ is designed for screening. Women use this form to describe their symptoms and reactions during each of the three phases of their most recent menstrual cycle. It may be administered at any time during the cycle. Form T is designed for treatment evaluation, and research application.

This study attempted to do the two-stage design of the translation of the MDQ (Form C-Cycle). Previous studies have translated only 14 items of the MDQ (Form C - Cycle) and only done the internal reliability test. This study is expected to do a two-stage translation of the MDQ (Form C - Cycle) Chinese version, and to do the reliability and validity test.

• Study Type: Observational
• Enrollment (Actual): 219

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • CMUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Healthy females aged 20-40 years with regular and predictable menstrual cycles, fluent in speaking, reading, and writing Chinese in Taiwan

Description

Inclusion Criteria:

1. A eumenorrheic healthy woman with a regular menstrual cycle for three months, predictable, and a period between 24-38 days that lasts less than 8 days.
2. No hormonal contraceptives have been used in the past six months.
3. No history of smoking, drinking or drug abuse.

Exclusion Criteria:

1. Women with systemic diseases, cardiovascular diseases, liver diseases, kidney diseases, diabetes or thyroid diseases.
2. Taking any medicine due to chronic disease
3. Women with mental illness

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
eumenorrheic healthy women; women with a regular menstrual cycle for three months, predictable, and a period between 24-38 days that lasts less than 8 days.	Other: questionnaire; Filling the menstrual distress questionnaire, short-form McGill pain questionnaire, present pain index, visual analog scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
questionnaire data	Statistical analyses were conducted using IBM SPSS Statistics 24 for Windows (IBM Inc., Armonk, NY, USA)	up to 8 weeks

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Su Shan-Yu, M.D. Ph.D., China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2019
• Primary Completion (Actual): June 22, 2019
• Study Completion (Actual): December 24, 2019

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 28, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 28, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Menstrual Distress Questionnaire, Two-Stage Translation
• Other Study ID Numbers: CMUH108-REC3-052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No