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Not yet recruiting NCT06987838

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

No phase Interventional Primary Dysmenorrhea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pharmacological treatment, Virtual reality.
Who it may be relevant to
Registry conditions: Primary Dysmenorrhea. Basic parameters: 17 years — 21 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Virtual Reality on Prostaglandin Levels in Adolescent Females With Primary Dysmenorrhea: A Randomized Controlled Trial

Overview

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.

Interventions

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

Primary outcome measures

  • Visual Analogue Scale (VAS) [Time frame: 12 weeks]
  • Assessment of Prostaglandin Levels [Time frame: 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Misr University for Science and Technology — Giza

Identifiers

NCT: NCT06987838 · P.T.REC/012/005600

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗