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NCT Number: NCT06987838

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

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

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Key information

Conditions

Primary Dysmenorrhea

Age range

17 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Misr University for Science and Technology

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacological treatment

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.

Other names: Ibuprofen (400 mg)

Virtual Reality

Other

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

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sally Mohamed Saeed, PhD

CONTACT

[email protected]

+20 100 466 9647

Sponsors and collaborators

Lead sponsor

Benha National University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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