Primary DysmenorrheaNCT07350902
Impact of Primary Dysmenorrhea on Academic Performance and Quality of Life Among Medical Students at Sohag University
An observational study of Primary Dysmenorrhea, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- self administered questionnaire
- How many people
- 402 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- • Undergraduate females from the 3 selected faculties in Sohag University
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
In the world, the estimated prevalence of dysmenorrhea ranges from 45% to 93% of women of reproductive age, with adolescents having the highest rates of dysmenorrhea.
Studies suggest that approximately 140 million hours are lost annually from school or work owing to dysmenorrhea. It is a leading cause of recurrent short-term school absenteeism, lack of concentration, no active participation, inability to do homework, failure in an exam, and limitation of activity.
An estimated 15% of adolescent females describe their pain as severe, impacting their quality of life. These adolescents can miss 1 to 3 days of school per menstrual cycle.
Studies have noted that dysmenorrhea can lead to lower academic performance (AP) and poor quality of sleep, resulting in mood changes, such as anxiety and depression
- Conditions
- Primary Dysmenorrhea
- Being tested
- self administered questionnaire
- Keywords
- Dysmenorrhea, Academic performance
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self administered questionnaireOther
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: -
- The first section: Information on socio demographic and lifestyle, The survey consisted of inquiries as (sex, age, , marital status, residence, physical exercise, drinking cofee ….)
- The second section: Including Information on menstrual history:
- Age at menarche, the regularity of menses, the presence of dysmenorrhea or not……etc.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: December 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amera Fayez Shenouda, Sohag University
- Investigators
- Amira Fayez Shenouda, Ass lecturer, Principal investigator, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350902
- Sponsor's protocol ID
- Soh-Med--25-12-1MD
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Primary Dysmenorrhea on Academic Performance and Quality of Life Among Medical Students at Sohag University
- ClinicalTrials.gov ID
- NCT07350902
- Acronym / sponsor ID
- Soh-Med--25-12-1MD
- Conditions
- Primary Dysmenorrhea
- Keywords
- Dysmenorrhea, Academic performance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
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.
Detailed description
In the world, the estimated prevalence of dysmenorrhea ranges from 45% to 93% of women of reproductive age, with adolescents having the highest rates of dysmenorrhea.
Studies suggest that approximately 140 million hours are lost annually from school or work owing to dysmenorrhea. It is a leading cause of recurrent short-term school absenteeism, lack of concentration, no active participation, inability to do homework, failure in an exam, and limitation of activity.
An estimated 15% of adolescent females describe their pain as severe, impacting their quality of life. These adolescents can miss 1 to 3 days of school per menstrual cycle.
Studies have noted that dysmenorrhea can lead to lower academic performance (AP) and poor quality of sleep, resulting in mood changes, such as anxiety and depression
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- • Undergraduate females from the 3 selected faculties in Sohag University
Key exclusion criteria (3 listed)
- • Students who will refuse to participate in this study.
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 |
|---|---|---|
| self administered questionnaireData 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 | Other | – |
Primary outcome
The WaLIDD questionnaire
Time frame: December 2027
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
"DysmenQoL questionnaire" (dysmenorrhea and quality of life)
Time frame: December 2027
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- 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.
Amira Fayez Shenouda, Ass lecturer principal investigator
Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dysmenorrhea, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Fayez, Ass.lecturer (01279954256, amerahfayez@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The WaLIDD questionnaire (time frame: December 2027). The study lists 2 primary outcomes in all. 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 20 Jan 2026.