The Menstrual Distress Questionnaire (MEDI-Q) Reliability and Validity of the Turkish Version

Menstruation Disturbances Clinical Trial

Official title:

The Menstrual Distress Questionnaire (MEDI-Q) Reliability and Validity of the Turkish Version

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05948358
• Other study ID #: Menstrual Distress
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: July 2023
• Source: Karabuk University
• Contact: Nurcan Contarli, MSc
• Phone: 03704189396
• Email: nurcancontarli[@]karabuk.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: November 30, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Female gender
• 18-35 years old
• Volunteer
• Native speaker Turkish

Exclusion Criteria:

• Pregnancy or breastfeeding
• Having a mental health problem

Related Conditions & MeSH terms

• Menstruation Disturbances

Intervention

Other:
• Menstrual Distress Questionnaire
The Menstrual Distress Questionnaire (MEDI-Q) is a new tool originally developed in Italian that comprehensively evaluates menstrual-related distress.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karabuk University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Menstrual Distress Questionnaire (MEDI-Q)	The Menstrual Distress Questionnaire (MEDI-Q) is a new tool originally developed in Italian that comprehensively evaluates menstrual-related distress.	10 minutes