NCT04452227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

Same day

First QC Date

June 21, 2020

Last Update Submit

June 28, 2020

Conditions

Non-disease State

Keywords

Menstrual Distress Questionnaire, Two-Stage Translation

Outcome Measures

Primary Outcomes (1)

  • questionnaire data

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

    up to 8 weeks

Study Arms (1)

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

Interventions

questionnaireOTHER

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

eumenorrheic healthy women

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMUH

Taichung, 404, Taiwan

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Su Shan-Yu, M.D. Ph.D.

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2020

First Posted

June 30, 2020

Study Start

June 22, 2019

Primary Completion

June 22, 2019

Study Completion

December 24, 2019

Last Updated

June 30, 2020

Record last verified: 2020-06

Locations

TW(1)