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

NCT ID: NCT04452227

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-22

Study Completion Date

2019-12-24

Brief Summary

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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

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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.

Conditions

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Non-disease State

Keywords

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Menstrual Distress Questionnaire, Two-Stage Translation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

questionnaire

Intervention Type OTHER

Filling the menstrual distress questionnaire, short-form McGill pain questionnaire, present pain index, visual analog scale

Interventions

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questionnaire

Filling the menstrual distress questionnaire, short-form McGill pain questionnaire, present pain index, visual analog scale

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Su Shan-Yu, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

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CMUH

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMUH108-REC3-052

Identifier Type: -

Identifier Source: org_study_id