Primary DysmenorrheaNCT06987838
Effect of Virtual Reality on Prostaglandin Levels in Adolescent Females With Primary Dysmenorrhea
A study testing Pharmacological treatment and Virtual reality in people with Primary Dysmenorrhea, run by Benha National University at 1 site in Egypt.
Trial summary
This study will be conducted to study the effect of virtual reality therapy on prostaglandin levels in adolescent females with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 17 to 21 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Pharmacological treatment and Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 25 May 2025to 1 Sep 2025
- Phase
- Interventional
- 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 17 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 17- 21 years old.
- The body mass index (BMI) < 30 kg/m2.
- Unmarried females.
- Females with dysmenorrhea pain.
- Females with regular menstrual cycles.
- Females with normal gynecology.
Who cannot join
- Have a pathological disease related to reproduction.
- Students who use analgesic drugs for 3 months/3 menstrual cycles.
- Students with menstrual pain secondary to diagnosed organic or inflammatory causes.
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
Official title: Effect of Virtual Reality on Prostaglandin Levels in Adolescent Females With Primary Dysmenorrhea: A Randomized Controlled Trial
This study will be conducted to study the effect of virtual reality therapy on prostaglandin levels in adolescent females with primary dysmenorrhea.
Read the detailed description
Primary dysmenorrhea is thought to be caused by excessive levels of prostaglandins, which are hormones that stimulate the uterus to contract during menstruation and childbirth, Treatment must be tailored to individual patient symptoms. Pharmacologic management with non-steroidal anti-inflammatory medications and/or combined hormonal contraceptives is most common. Heat therapy, exercise, vitamins and dietary supplements have limited evidence and can be offered for patients seeking non-pharmacologic adjunctive or alternative options. Greater awareness for both health-care providers and patients allow for early intervention to reduce impact on quality of life and life course potential. The significance of this study to assess the effect of virtual reality therapy on primary dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Pharmacological treatment, Virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacological treatmentDrug
Also called Ibuprofen (400 mg)
All participants in the two groups will receive pharmacological treatment in the form of ibuprofen 400 mg, three times per day, during the first 2 days of menstruation, for 3 menstrual cycles.
Virtual realityOther
The experimental group will receive virtual reality during the first 2 days of menstruation, for 3 menstrual cycles.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacological treatment | Other | It will consist of 25 girls, who will receive pharmacological treatment in the form of ibuprofen 400 mg, three times per day, during the first 2 days of menstruation, for 3 menstrual cycles. Receives: Drug: Pharmacological treatment |
| Virtual reality + Pharmacological treatment | Experimental | It will consist of 25 girls, who will receive the same pharmacological treatment in addition to virtual reality during the first 2 days of menstruation, for 3 menstrual cycles. Receives: Drug: Pharmacological treatment; Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Participants in both groups will complete the visual analogue scale (VAS) before the start of treatment and after 3 menstrual cycles of treatment. The VAS is a 10 cm horizontal line on which the participants' pain intensity is represented by a point between the extremes of "no pain at all "and "worst pain imaginable". Each girl will be asked to mark a point on the line between the extreme that was related to her pain intensity. Then, the distance will be measured each time from the left end of the line to the marked point to obtain the VAS score for pain intensity of dysmenorrhea.
Measured: 12 weeks
Assessment of Prostaglandin Levels
Blood samples will be collected from each girl in both groups to measure the levels of plasma PGF2α before the start of treatment and after 3 menstrual cycles of treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start25 May 2025 (estimated)
- Primary completion25 Aug 2025 (estimated)
- Study completion1 Sep 2025 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Mohamed Saeed, Benha National University
- Investigators
- Sally Mohamed Saeed, PhD, Principal investigator, Lecturer, Benha National UniversityMalak Adel El Mahdy, PhD, Principal investigator, Lecturer, Al Hayah UniversitySarah Abdullah Mohamed Elsamahy, PhD, PhD, Principal investigator, Lecturer, Misr University for Science and TechnologySamah Mahmoud Ahmed sheha, PhD, Principal investigator, Lecturer, Misr University for Science and TechnologyNaglaa fathey moustafa, PhD, Principal investigator, Lecturer, Al Hayah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987838
- Sponsor's protocol ID
- P.T.REC/012/005600
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Prostaglandin Levels in Adolescent Females With Primary Dysmenorrhea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06987838
- Acronym / sponsor ID
- P.T.REC/012/005600
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Benha National UniversityUniversity, hospital or other
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 23 May 2025 (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.
This study will be conducted to study the effect of virtual reality therapy on prostaglandin levels in adolescent females with primary dysmenorrhea.
Detailed description
Primary dysmenorrhea is thought to be caused by excessive levels of prostaglandins, which are hormones that stimulate the uterus to contract during menstruation and childbirth, Treatment must be tailored to individual patient symptoms. Pharmacologic management with non-steroidal anti-inflammatory medications and/or combined hormonal contraceptives is most common. Heat therapy, exercise, vitamins and dietary supplements have limited evidence and can be offered for patients seeking non-pharmacologic adjunctive or alternative options. Greater awareness for both health-care providers and patients allow for early intervention to reduce impact on quality of life and life course potential. The significance of this study to assess the effect of virtual reality therapy on primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacological treatment | Other | Drug: Pharmacological treatmentIt will consist of 25 girls, who will receive pharmacological treatment in the form of ibuprofen 400 mg, three times per day, during the first 2 days of menstruation, for 3 menstrual cycles. |
| Virtual reality + Pharmacological treatment | Experimental | Drug: Pharmacological treatment, Other: Virtual realityIt will consist of 25 girls, who will receive the same pharmacological treatment in addition to virtual reality during the first 2 days of menstruation, for 3 menstrual cycles. |
Who may qualify
- Ages
- 17 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 17- 21 years old.
- The body mass index (BMI) < 30 kg/m2.
- Unmarried females.
- Females with dysmenorrhea pain.
- Females with regular menstrual cycles.
Key exclusion criteria (3 listed)
- Have a pathological disease related to reproduction.
- Students who use analgesic drugs for 3 months/3 menstrual cycles.
- Students with menstrual pain secondary to diagnosed organic or inflammatory causes.
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 |
|---|---|---|
| Pharmacological treatmentAlso: Ibuprofen (400 mg)All participants in the two groups will receive pharmacological treatment in the form of ibuprofen 400 mg, three times per day, during the first 2 days of menstruation, for 3 menstrual cycles. | Drug | Pharmacological treatment, Virtual reality + Pharmacological treatment |
| Virtual realityThe experimental group will receive virtual reality during the first 2 days of menstruation, for 3 menstrual cycles. | Other | Virtual reality + Pharmacological treatment |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 12 weeks
Participants in both groups will complete the visual analogue scale (VAS) before the start of treatment and after 3 menstrual cycles of treatment. The VAS is a 10 cm horizontal line on which the participants' pain intensity is represented by a point between the extremes of "no pain at all "and "worst pain imaginable". Each girl will be asked to mark a point on the line between the extreme that was related to her pain intensity. Then, the distance will be measured each time from the left end of the line to the marked point to obtain the VAS score for pain intensity of dysmenorrhea.
Assessment of Prostaglandin Levels
Time frame: 12 weeks
Blood samples will be collected from each girl in both groups to measure the levels of plasma PGF2α before the start of treatment and after 3 menstrual cycles of treatment.
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 23 May 2025.
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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.
Sally Mohamed Saeed, PhD principal investigator
Lecturer, Benha National University
Malak Adel El Mahdy, PhD principal investigator
Lecturer, Al Hayah University
Sarah Abdullah Mohamed Elsamahy, PhD, PhD principal investigator
Lecturer, Misr University for Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacological treatment and Virtual reality in people with Primary Dysmenorrhea, run by Benha National 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 6 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 23 May 2025. 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 Sally Mohamed Saeed, PhD (+20 100 466 9647, sally_hashem@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 12 weeks). 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 23 May 2025.