Clinical trial NCT06061588: "Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches"
Official title: Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches: Randomized Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorders
Virtual Reality
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 0. -15. -30.-60.-120. minutes
measure: Rescue analgesic use
timeFrame: 120.minute
Secondary outcomes:
measure: Side effects
timeFrame: 120.minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: SAFA DÖNMEZ, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.