Skip to main content
OpenTrials
Completed

NCT Number: NCT06061588

"Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches"

The primary objective of this research is to investigate the effects of virtual reality technology on the treatment of migraine-type headaches and assess how this technology may impact the severity, frequency, and duration of headaches.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

This is a non-randomized controlled prospective study with the primary objective of investigating the effects of virtual reality technology on the treatment of migraine-type headaches and assessing how this technology can potentially influence the severity, frequency, and duration of headaches. Additionally, the study aims to analyze the impact of virtual reality technology on the neurological and psychological components of headaches, evaluate potential improvements in the quality of life for migraine patients undergoing virtual reality therapy, monitor the long-term effects of virtual reality in migraine treatment, and assess its sustainability. The study is divided into two arms, labeled as Arm 1 and Arm 2, with randomization being carried out by the principal investigator. All patients consenting to participate in the study will receive a standard treatment of 150 cc normal saline containing arveles (50 mg dexketoprofen), and no patient will be left untreated. One group will receive only the standard treatment (control group), while the other group will receive both the standard treatment and, in addition, virtual reality therapy consisting of a virtual environment simulating moonlight by the dark seaside or a campfire ambiance with classical music (calm, slow, and soothing) using virtual reality goggles.

Prior to medication administration (0.min) and at 15, 30, 60, and 120 minutes, patients' VAS scores will be recorded. Adult patients diagnosed with migraines who have agreed to participate in the study will be included. Patients will be eligible to participate in the study if they meet specific inclusion criteria. The severity of pain in patients diagnosed with migraines and the effectiveness of treatments used for migraine attacks will constitute the dependent variables of the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • Under the age of 65
  • Willing to participate in the study
  • Previously diagnosed with migraine
  • Marking a VAS score of 50 or higher
  • Not considered for any additional preliminary diagnosis
  • No known adverse history to the active ingredient of the medication to be used
  • Conscious
  • Cooperatively oriented

Exclusion criteria

  • Under 18 years of age or over 65 years of age
  • Not willing to participate in the study
  • Displaying vital signs outside of normal limits
  • With a known history of adverse reactions to NSAIDs
  • Unable to determine the severity of pain on the VAS
  • Scoring 50 mm or lower on the VAS
  • Pregnant individuals
  • Individuals with advanced systemic illness
  • Those with malignancies
  • Patients with chronic liver and kidney disease
  • Using sedative and analgesic neuro-psychiatric drugs
  • With a history of psychological and neurological diseases
  • Having taken analgesics within 8 hours prior to examination

Treatment and study plan

Virtual reality

Device

The use of virtual reality as an adjunct to routine treatment.

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 0. -15. -30.-60.-120. minutes

    The change in patients' pain conditions with treatment. The pain is determined using a 100 mm scale. Patients are instructed to mark the level of pain they experience, with 0 mm indicating no pain and 100 mm indicating the presence of maximum pain.

  2. Rescue analgesic use

    Time frame: 120.minute

    For patients with a VAS score 50mm or higher at 120.minute rescue therapy was planned.

Secondary outcomes

  1. Side effects

    Time frame: 120.minute

    The difference between two groups observed in terms of side effects were recorded.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches: Randomized Observational Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2023
Registry last updated
May 6, 2024

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.

Published trials that share one or more normalized conditions with this study.