NCT07382947

Brief Summary

The most common symptom that occurs during the menstrual cycle is cramping pain in the lower abdomen. This pain during the menstrual cycle is called dysmenorrhea. It is one of the most common causes of pelvic pain in women. Dysmenorrhea is categorized into two types: primary and secondary. Primary dysmenorrhea manifests as painful cramps during the menstrual period without a pelvic pathology. The pain can radiate to the lower back, pelvis, and upper thigh. Although the etiology of primary dysmenorrhea is not fully known, four main causes have been identified. The etiology of primary dysmenorrhea is endocrine causes, increased prostaglandin levels, increased uterine activity, and psychological causes. Among these factors, increased uterine contractions are thought to be particularly effective in causing the pain. Ischemia in the uterus, which occurs with increased contractions, is among the factors that increase the pain. Primary dysmenorrhea has a prevalence ranging from 45% to 95%. Secondary dysmenorrhea, on the other hand, results from underlying pathological causes such as endometriosis, adenomyosis, uterine fibroids, or pelvic infections. Common symptoms of dysmenorrhea include lower abdominal pain along with headache, numbness, sleep disturbances, depression, vomiting, tender breasts, nausea, diarrhea, and increased urine output.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 26, 2026

Last Update Submit

January 26, 2026

Conditions

Keywords

menstrual managementgenerational differenceswomens healthmenstrual health

Outcome Measures

Primary Outcomes (8)

  • Menstruation Symptom Scale (MSQ)

    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:

    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:

    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):

    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):

    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:

    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):

    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):

    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

Study Arms (3)

X generation

ACTIVE COMPARATOR

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.

Other: survey data entry

Y Generation

ACTIVE COMPARATOR

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.

Other: survey data entry

Z Generation

ACTIVE COMPARATOR

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.

Other: survey data entry

Interventions

survey data entry

X generationY GenerationZ Generation

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batman Center

Batman, Gültepe, 72000, Turkey (Türkiye)

Location

Study Officials

  • merve yiğit kocamer, lecturer

    Batman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Generation X group Generation Y group Generation Z group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start

November 1, 2025

Primary Completion

January 10, 2026

Study Completion

January 10, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations