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

B

Benha National University

Status

Not yet enrolling

Conditions

Primary Dysmenorrhea

Treatments

Other: Virtual reality
Drug: Pharmacological treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06987838
P.T.REC/012/005600

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

17 to 21 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Pharmacological treatment
Other group
Description:
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.
Treatment:
Drug: Pharmacological treatment
Virtual reality + Pharmacological treatment
Experimental group
Description:
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.
Treatment:
Drug: Pharmacological treatment
Other: Virtual reality

Trial contacts and locations

1

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Central trial contact

Sally Mohamed Saeed, PhD

Data sourced from clinicaltrials.gov

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