NCT06987838

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

May 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 16, 2025

Last Update Submit

May 16, 2025

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    12 weeks

Study Arms (2)

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.

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.

Drug: Pharmacological treatmentOther: Virtual reality

Interventions

Pharmacological treatmentDRUG

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.

Also known as: Ibuprofen (400 mg)
Pharmacological treatmentVirtual reality + Pharmacological treatment
Virtual realityOTHER

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

Virtual reality + Pharmacological treatment

Eligibility Criteria

Age17 Years - 21 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr University for Science and Technology

Giza, Egypt

Location

MeSH Terms

Interventions

Drug TherapyIbuprofen

Intervention Hierarchy (Ancestors)

TherapeuticsPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Sally Mohamed Saeed, PhD

    Lecturer, Benha National University

    PRINCIPAL INVESTIGATOR

  • Malak Adel El Mahdy, PhD

    Lecturer, Al Hayah University

    PRINCIPAL INVESTIGATOR

  • Sarah Abdullah Mohamed Elsamahy, PhD, PhD

    Lecturer, Misr University for Science and Technology

    PRINCIPAL INVESTIGATOR

  • Samah Mahmoud Ahmed sheha, PhD

    Lecturer, Misr University for Science and Technology

    PRINCIPAL INVESTIGATOR

  • Naglaa fathey moustafa, PhD

    Lecturer, Al Hayah University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Mohamed Saeed, PhD

CONTACT

+20 100 466 9647sally_hashem@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2025

First Posted

May 23, 2025

Study Start

May 25, 2025

Primary Completion

August 25, 2025

Study Completion

September 1, 2025

Last Updated

May 23, 2025

Record last verified: 2025-05

Locations

EG(1)