Menstruation DisturbancesNCT05948358
The Menstrual Distress Questionnaire (MEDI-Q) Reliability and Validity of the Turkish Version
An observational study of Menstruation Disturbances, run by Karabuk University.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation Disturbances
- What is being tested?
- Menstrual Distress Questionnaire
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female university students between the ages of 18 and 45 who is native Turkish speaker
Who may be able to join
- Female gender
- 18-35 years old
- Volunteer
- Native speaker Turkish
Who cannot join
- Pregnancy or breastfeeding
- Having a mental health problem
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Menstruation Disturbances
- Being tested
- Menstrual Distress Questionnaire
- Medical subject headings
- Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menstrual Distress QuestionnaireOther
The Menstrual Distress Questionnaire (MEDI-Q) is a new tool originally developed in Italian that comprehensively evaluates menstrual-related distress.
| Study group | Role | What they receive |
|---|---|---|
| Females | 18 Years to 45 Years (Adult ) Receives: Other: Menstrual Distress Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstruation DisturbancesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurcan Contarli, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948358
- Sponsor's protocol ID
- Menstrual Distress
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Menstrual Distress Questionnaire (MEDI-Q) Reliability and Validity of the Turkish Version
- ClinicalTrials.gov ID
- NCT05948358
- Acronym / sponsor ID
- Menstrual Distress
- Conditions
- Menstruation Disturbances
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Females | – | Other: Menstrual Distress Questionnaire18 Years to 45 Years (Adult ) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female university students between the ages of 18 and 45 who is native Turkish speaker
Key inclusion criteria (4 listed)
- Female gender
- 18-35 years old
- Volunteer
- Native speaker Turkish
Key exclusion criteria (2 listed)
- Pregnancy or breastfeeding
- Having a mental health problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menstrual Distress QuestionnaireThe Menstrual Distress Questionnaire (MEDI-Q) is a new tool originally developed in Italian that comprehensively evaluates menstrual-related distress. | Other | Females |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstruation Disturbances, run by Karabuk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurcan Contarli, MSc (03704189396 ext. 9396, nurcancontarli@karabuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Menstrual Distress Questionnaire (MEDI-Q) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.