NCT07350902

Brief Summary

Pain is an unpleasant sensation that negatively affects individual experiencing it, depending on its quality, intensity, location, and duration. One of the causes of pain among females is dysmenorrhea. Dysmenorrhea is defined as pain during menstruation. A significant population of females experience mild, moderate or severe pain during menstruation. Primary dysmenorrhea is defined as dysmenorrhea with the absence of any organic pathology starting 6-12 months after the menarche and frequently continuing till menopause, while secondary dysmenorrhea results from gynecologic problems such as adenomyosis, endometriosis, uterine fibroid and others.

Trial Health

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Trial Health Score

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

Enrollment
402

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress18%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

December 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 20, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

December 21, 2025

Last Update Submit

January 9, 2026

Conditions

Keywords

DysmenorrheaAcademic performance

Outcome Measures

Primary Outcomes (2)

  • The WaLIDD questionnaire

    The WaLIDD questionnaire contains 4 questions : Working ability = 0: never, 1: sometimes, 2: regularly, 3: always; Location = 0: none, 1: 1 location. 2: 2-3 locations, 3: 4 locations; Intensity = 0: never, 1: sometimes, 2: regularly, 3: always; Day of Pain = 0: none, 1: 1-2 days, 2: 3-4 days, 3: more than 5 days So, Each of the four questions is scored from 0 to 3 Total score: The total score ranges from 0 to 12 The interpretation of the WaLIDD questionnaire is as follows: 0 = No Dysmenorrhea 1-4 = Mild Dysmenorrhea 5-7 = Moderate Dysmenorrhea 8-12 = Severe Dysmenorrhea

    December 2027

  • "DysmenQoL questionnaire" (dysmenorrhea and quality of life)

    it is represented by 20 statements about the negative effects of dysmenorrhea on quality of life (effects on health and feelings, relationships with family members or friends, couple relationships and professional activity). It consists of twenty statements ,the participants give a score from 1 to 5 for each statement: 1-"Never"; 2-"Few cases"; 3-"Sometimes"; 4-"Most of the time" ; 5-"Every time". We calculate the sum of the scores for each statement and we call it "DysmenQoL score" whose value could vary between 20 and 100. So, high scores indicate low quality of life. The DysmenQoL questionnaire proved to be a reliable and valid method for evaluating the impact of dysmenorrhea on the quality of life.

    December 2027

Interventions

Data will be collected through Self-Administered will be distributed to the students after informed consent from participants, The questionnaire is divided into five sections: - 1. The first section: Information on socio demographic and lifestyle, The survey consisted of inquiries as (sex, age, , marital status, residence, physical exercise, drinking cofee ….) 2. The second section: Including Information on menstrual history: \- Age at menarche, the regularity of menses, the presence of dysmenorrhea or not……etc. 3. The third section: The WaLIDD questionnaire, namely (Working ability, Location, Intensity, Days of pain) The forth section: The validated dysmenorrhea and AP impact questionnaire in English was used for the survey The last section is named "DysmenQoL questionnaire" (dysmenorrhea and quality of life) . and it is represented by 20 statements about the negative effects of dysmenorrhea on quality of life

Eligibility Criteria

Age19 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

A cross-sectional survey will be conducted in three randomly chosen faculties' in Sohag University, The sample will be selected as follow: * 3 medical faculties were selected randomly. \[Faculty of Medicine, and faculty of Nursing\] medical female students are the study population * Students will be selected by stratified random sampling technique. * Students from each grade except the first grade will be selected by using random sampling technique after fulfilling the eligibility criteria.

You may qualify if:

  • Undergraduate females from the 3 selected faculties in Sohag University

You may not qualify if:

  • Students who will refuse to participate in this study.
  • Pregnant females \\ females with amenorrhea.
  • Females with gynecological problems as adenomyosis, uterine fibroids and others to exclude secondary dysmenorrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Amira Fayez Shenouda, Ass lecturer

    Faculty of Medicine, Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira Fayez, Ass.lecturer

CONTACT

Shimaa Harris, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at Public Health and Community department at Sohag University

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 20, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 20, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations