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NCT Number: NCT04452227

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

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.

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

CMUH

Taichung, 404, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.
  • No hormonal contraceptives have been used in the past six months.
  • No history of smoking, drinking or drug abuse.

Exclusion criteria

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

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. questionnaire data

    Time frame: up to 8 weeks

    Statistical analyses were conducted using IBM SPSS Statistics 24 for Windows (IBM Inc., Armonk, NY, USA)

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 30, 2020
Registry last updated
Jun 30, 2020

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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