Clinical trial NCT04452227: A Two-stage Translation of the Chinese Version Menstrual Distress Questionnaire
Official title: A Two-stage Translation of the Chinese Version Menstrual Distress Questionnaire: a Physical, Psychological, and Behavior Study in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-disease State
Keywords: Menstrual Distress Questionnaire, Two-Stage Translation
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 219
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: questionnaire data
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: CMUH
Study officials:
affiliation: China Medical University Hospital
name: Su Shan-Yu, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: