NCT05948358

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

July 9, 2023

Last Update Submit

July 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Females

18 Years to 45 Years (Adult )

Other: Menstrual Distress Questionnaire

Interventions

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

Females

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female university students between the ages of 18 and 45 who is native Turkish speaker

You may qualify if:

  • Female gender
  • years old
  • Volunteer
  • Native speaker Turkish

You may not qualify if:

  • Pregnancy or breastfeeding
  • Having a mental health problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2023

First Posted

July 17, 2023

Study Start

September 1, 2023

Primary Completion

October 31, 2023

Study Completion

November 30, 2023

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share