- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07382947
MENSTRUATİON MANAGEMENT ACCORDİNG TO GENERATİONS
EXAMINING MENSTRUAL MANAGEMENT AMONG WOMEN OF DIFFERENT GENERATIONS
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gültepe
-
Batman, Gültepe, Turkey (Türkiye), 72000
- Batman Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being female
- Being between 18-55 years of age
- Having a menstrual cycle
- Voluntarily agreeing to participate in the study
- Approving the informed consent form
Exclusion Criteria:
- Having a serious chronic or neurological disease
- Using hormonal treatment or birth control method (within the last 6 months)
- Being pregnant or in menopause
- Having an incomplete or incorrectly completed questionnaire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: X generation
Data will be collected online (Google Forms) on a voluntary basis.
At the beginning of the survey, participants will be presented with the purpose of the research, privacy principles, and an informed consent form.
|
survey data entry
|
|
Active Comparator: Y Generation
Data will be collected online (Google Forms) on a voluntary basis.
At the beginning of the survey, participants will be presented with the purpose of the research, privacy principles, and an informed consent form.
|
survey data entry
|
|
Active Comparator: Z Generation
Data will be collected online (Google Forms) on a voluntary basis.
At the beginning of the survey, participants will be presented with the purpose of the research, privacy principles, and an informed consent form.
|
survey data entry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Menstruation Symptom Scale (MSQ)
Time Frame: 15 minute
|
Developed by Chesney and Tasto in 1975, the MSQ was adapted into Turkish by Güvenç et al. in 2014. The scale is a five-point Likert-type scale consisting of 22 items. Participants rate menstruation-related symptoms on a scale of 1 (never) to 5 (always). The scale is divided into three sub-dimensions: 'Negative Effects/Somatic Complaints', 'Menstrual Pain Symptoms', and 'Coping Mechanisms'. The MSQ score is calculated from the average scores of the items, and a higher score indicates an increase in the severity of symptoms. |
15 minute
|
|
Attitude Toward Menstrution Scale:
Time Frame: 15 minute
|
Attitude Toward Menstruation Scale: The Turkish validity and reliability study of the scale developed by Brooks-Gunn and Ruble in 1980 was conducted by Kulakaç et al. in 2008.
The adapted version of the scale, which is originally a 7-point Likert type, is a 5-point Likert type with a scoring range of 1-5 (1-Strongly disagree, 5-Strongly agree).
The scale, which contains a total of 31 items, has 5 sub-dimensions: "Menstruation as a debilitating event" (7 items), "Menstruation as a disturbing event" (5 items), "Menstruation as a natural event" (5 items), "Noticing/sensing changes before and during menstruation" (8 items), "Denial of the effects of menstruation" (6 items).
A high average score on the sub-dimensions or the entire scale indicates a "positive" attitude towards menstruation.
|
15 minute
|
|
WaLIDD (Working ability, Location, Intensity, Days of pain, Dysmenorrhea) Scale:
Time Frame: 5 minute
|
It was first developed by Teherán et al. (2013) and is designed to assess the severity, duration, location, and impact on daily life of dysmenorrhea (menstrual pain) in women. The Turkish adaptation of the scale was carried out by H. Arıkan and E. Erol and published in 2025. |
5 minute
|
|
Visual Analog Scale (VAS):
Time Frame: 1 minute
|
The Visual Analog Scale (VAS) was used to subjectively determine the pain of the individuals participating in the study. Participants will be asked to indicate the intensity of their pain on a 0-10 cm scale. 1-3 cm will be considered mild, 4-7 cm moderate, and 8-10 cm severe tension. |
1 minute
|
|
Turkish Health Literacy Scale (TSOY-32):
Time Frame: 5 minute
|
It is a scale developed to measure individuals' ability to find, understand, evaluate, and use health information.
It was adapted to the Turkish society by Abacıgil, Harlak, and Okyay (2016), based on the European Health Literacy Scale (HLS-EU-Q47).
The scale, consisting of a total of 32 items, evaluates in three main areas: health services, disease prevention, and health promotion.
In the validity and reliability analyses, Cronbach's α value was found to be 0.89.
|
5 minute
|
|
Step Count:
Time Frame: 1 minute
|
The WHO defines mobile health as the support of medical and public health applications by mobile devices such as mobile phones, patient monitoring devices, and other wireless devices. Mobile phones are the most commonly used devices in the implementation of mobile health (WHO, 2011). Many studies have reported that pedometers installed on smartphones provide accurate step counting at different walking speeds and with different carrying methods (Funk et al., 2018; Thomson et al., 2019). A-B Participants' physical activity levels were monitored for 7 days through the Google Fit application installed on smartphones. The application automatically records the daily step count, distance covered, and estimated energy expenditure using the device's accelerometer sensor. Participants were asked to keep their phones on them throughout the day and to keep the application open in the background. The average daily step count obtained at the end of 7 days was evaluated as an indicator o |
1 minute
|
|
Pittsburgh Sleep Quality Index (PSQI):
Time Frame: 5 minute
|
Developed by Buysse and colleagues in 1989, the PSQI is a self-report questionnaire that assesses sleep quality and disturbances over the past month. A validity and reliability study conducted in Turkey by Ağargün and colleagues proved that the PSQI is consistent and valid in Turkish society. This scale, consisting of 24 questions, comprises 19 questions based on the individual's self-assessment and 5 questions answered by a spouse or roommate. Each question is scored between 0 and 3 to calculate the total score. A score of five or higher is generally considered poor sleep quality. |
5 minute
|
|
Short Form-12 (SF-12):
Time Frame: 5 minute
|
Participants' health-related quality of life was assessed using the Short Form-12 (SF-12) scale. SF-12 is a short questionnaire consisting of two sub-dimensions, physical and mental health, measuring participants' general health status and quality of life. The physical component score (Physical Component Summary, PCS) and the mental component score (Mental Component Summary, MCS) were calculated separately, with higher scores indicating better quality of life. The Turkish validity and reliability of the scale were established by Demiral et al. (2006). |
5 minute
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: merve yiğit kocamer, lecturer, Batman University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- BAU-FTR-MYK-03
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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