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

NCT06061588 | Completed

• 1 other identifier: Virtual Reality in Migraine
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine Disorders; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale

  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.

  0. -15. -30.-60.-120. minutes

• Rescue analgesic use

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

  120.minute

Secondary Outcomes (1)

• Side effects

  120.minute

Study Arms (2)

The case group

NO INTERVENTION

Included in the case group, patients diagnosed with migraine and experiencing headache will receive standard treatment, consisting of 50 mg of dexketoprofen within 150 cc of normal saline.

The control group

EXPERIMENTAL

The control group, in addition to standard treatment, will be treated with virtual reality therapy using VR goggles, which will create a virtual environment simulating moonlight by the dark seaside or a campfire ambiance with classical music (calm, slow, and soothing).

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

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

The control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (6)

• Bagher SM, Felemban OM, Alandijani AA, Tashkandi MM, Bhadila GY, Bagher AM. The effect of virtual reality distraction on anxiety level during dental treatment among anxious pediatric patients: a randomized clinical trial. J Clin Pediatr Dent. 2023 Jul;47(4):63-71. doi: 10.22514/jocpd.2023.036. Epub 2023 Jul 3.

  PMID: 37408348 BACKGROUND

• Almedhesh SA, Elgzar WT, Ibrahim HA, Osman HA. The effect of virtual reality on anxiety, stress, and hemodynamic parameters during cesarean section: A randomized controlled clinical trial. Saudi Med J. 2022 Apr;43(4):360-369. doi: 10.15537/smj.2022.43.4.20210921.

  PMID: 35414614 BACKGROUND

• Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.

  PMID: 35397973 BACKGROUND

• Stepien A, Kozubski W. [Comparison of the effectiveness of lysine acetylsalicylate and metoclopramide combination with ergotamine plus caffeine in the treatment of migraine attacks]. Wiad Lek. 2004;57(3-4):135-9. Polish.

  PMID: 15307520 BACKGROUND

• Chabriat H, Joire JE, Danchot J, Grippon P, Bousser MG. Combined oral lysine acetylsalicylate and metoclopramide in the acute treatment of migraine: a multicentre double-blind placebo-controlled study. Cephalalgia. 1994 Aug;14(4):297-300. doi: 10.1046/j.1468-2982.1994.1404297.x.

  PMID: 7954760 BACKGROUND

• Yavuz E, Gulacti U, Lok U, Turgut K. Intravenous metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in acute migraine attack in the emergency department: A randomized double-blind controlled trial. Am J Emerg Med. 2020 Nov;38(11):2254-2258. doi: 10.1016/j.ajem.2020.04.038. Epub 2020 Apr 15.

  PMID: 32359776 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• SAFA DÖNMEZ, M.D.

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: The study is planned to be conducted at two centers. Patients visiting one hospital will receive standard treatment, while patients visiting the other hospital will receive standard treatment plus VR goggles as part of their therapy. The group receiving standard treatment will constitute the case group, while the other group will form the control group.

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: September 29, 2023
• Study Start: September 15, 2023
• Primary Completion: March 10, 2024
• Study Completion: March 10, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)