Effect of Virtual Reality on Prostaglandin Levels in Adolescent Females With Primary Dysmenorrhea

NCT ID: NCT06987838

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-25

Study Completion Date

2025-09-01

Brief Summary

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This study will be conducted to study the effect of virtual reality therapy on prostaglandin levels in adolescent females with primary dysmenorrhea.

Detailed Description

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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

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Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pharmacological treatment

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.

Group Type OTHER

Pharmacological treatment

Intervention Type DRUG

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 reality + Pharmacological treatment

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.

Group Type EXPERIMENTAL

Pharmacological treatment

Intervention Type DRUG

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 reality

Intervention Type OTHER

The experimental group will receive virtual reality during the first 2 days of menstruation, for 3 menstrual cycles.

Interventions

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Pharmacological treatment

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.

Intervention Type DRUG

Virtual reality

The experimental group will receive virtual reality during the first 2 days of menstruation, for 3 menstrual cycles.

Intervention Type OTHER

Other Intervention Names

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Ibuprofen (400 mg)

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha National University

OTHER

Sponsor Role lead

Responsible Party

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Sally Mohamed Saeed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sally Mohamed Saeed, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer, Benha National University

Malak Adel El Mahdy, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer, Al Hayah University

Sarah Abdullah Mohamed Elsamahy, PhD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer, Misr University for Science and Technology

Samah Mahmoud Ahmed sheha, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer, Misr University for Science and Technology

Naglaa fathey moustafa, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer, Al Hayah University

Locations

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Misr University for Science and Technology

Giza, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Sally Mohamed Saeed, PhD

Role: CONTACT

+20 100 466 9647

Other Identifiers

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P.T.REC/012/005600

Identifier Type: -

Identifier Source: org_study_id

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