- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05948358
The Menstrual Distress Questionnaire (MEDI-Q) Reliability and Validity of the Turkish Version
Menstruation is a process in which metabolic and hormonal changes occur periodically every month to maintain reproductive functions in women. This cycle, which continues from menarche to menopause, repeats approximately every 28 days and lasts 3-7 days (1). The menstrual cycle is divided into three phases, the follicular phase, the ovulation phase, and the luteal phase, in which the levels of estrogen and progesterone hormones change (2,3). In this cycle, which is regulated by the hormones released from the pituitary, hypothalamus and ovary, changes occur not only in the genital organs, but also in the nervous system, cardiovascular system, respiratory system, musculoskeletal system and metabolic functions (4). Responses to these changes, which cause physiological stress in the organism in women, are perceived in different degrees. The presence of recurrent abnormal bleeding or excessive pain may be a sign of various menstrual disorders (5). Evaluation of menstrual problems that negatively affect women's mood, social and work life is clinically important (6,7).
The scale, called Menstrual Distress Questionnaire (MEDI-Q), was developed by Vannuccini et al. (2021), it is a tool that comprehensively evaluates menstrual problems (8). MEDI-Q assesses the effects of menstrual symptoms on quality of life, recreational activities, work and social relationships. It consists of 25 items covering different areas of menstruation-related symptoms such as pain, discomfort, psychological and cognitive changes, and gastrointestinal disturbances. The level of distress caused by each symptom is assessed in the menstrual cycle phases, taking into account not only its impact on functionality and quality of life, but also its frequency. MEDI-Q is a scale with good test-retest reliability and internal consistency (Cronbach's = 0.85) (8,9). The scale provides a total score (MEDI-Q Total Score) and three subscales that assess general menstrual distress. Subscales; the number of distressing symptoms (MS) during menstruation, the mean level of distress related to menstrual symptoms (MSD), and the Menstrual Specificity Index (MESI) (8,9), which measures the proportion of symptoms at which distress exacerbates during the menstrual phase.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nurcan Contarli, MSc
- Phone Number: 9396 03704189396
- Email: nurcancontarli@karabuk.edu.tr
Study Contact Backup
- Name: Tarik Ozmen, PhD
- Phone Number: 9029 03704189029
- Email: tarikozmen@karabuk.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female gender
- 18-35 years old
- Volunteer
- Native speaker Turkish
Exclusion Criteria:
- Pregnancy or breastfeeding
- Having a mental health problem
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Females
18 Years to 45 Years (Adult )
|
The Menstrual Distress Questionnaire (MEDI-Q) is a new tool originally developed in Italian that comprehensively evaluates menstrual-related distress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Menstrual Distress Questionnaire (MEDI-Q)
Time Frame: 10 minutes
|
The Menstrual Distress Questionnaire (MEDI-Q) is a new tool originally developed in Italian that comprehensively evaluates menstrual-related distress.
|
10 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Menstrual Distress
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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