"Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches"
Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches: Randomized Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey, 06800
- Ankara City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: The case group
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.
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Experimental: The control group
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).
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The use of virtual reality as an adjunct to routine treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analogue Scale
Time Frame: 0. -15. -30.-60.-120. minutes
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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.
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0. -15. -30.-60.-120. minutes
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Rescue analgesic use
Time Frame: 120.minute
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For patients with a VAS score 50mm or higher at 120.minute rescue therapy was planned.
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120.minute
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Side effects
Time Frame: 120.minute
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The difference between two groups observed in terms of side effects were recorded.
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120.minute
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: SAFA DÖNMEZ, M.D., Ankara Bilkent City Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Virtual Reality in Migraine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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