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

Primary Purpose

Migraine Disorders, Virtual Reality

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Migraine Disorders

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years of age or older Under the age of 60 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 60 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

Sites / Locations

  • Ankara City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

The case group

The control group

Arm Description

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, 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2023
Last Updated
September 28, 2023
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT06061588
Brief Title
"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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 randomized observational 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Virtual Reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The case group
Arm Type
No Intervention
Arm Description
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.
Arm Title
The control group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
The use of virtual reality as an adjunct to routine treatment.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
15. -30.-60.-120. minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Under the age of 60 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 60 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SAFA DÖNMEZ, M.D.
Phone
+90 553 751 55 45
Email
drsafa0131@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
NURULLAH İSHAK IŞIK, M.D.
Phone
+90 553 751 55 45
Ext
7916
Email
nurullahishak01@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SAFA DÖNMEZ, M.D.
Organizational Affiliation
Ankara Bilkent City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication in a journal, the research will be shared with interested researchers and the editorial team of the published journal.
IPD Sharing Time Frame
After publication in a journal, the research will be shared with interested researchers and the editorial team of the published journal.
IPD Sharing Access Criteria
The editorial team of the journal and other researchers granted permission by the investigators.
Citations:
PubMed Identifier
37408348
Citation
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.
Results Reference
background
PubMed Identifier
35414614
Citation
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.
Results Reference
background
PubMed Identifier
35397973
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.
Results Reference
background
PubMed Identifier
15307520
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.
Results Reference
background
PubMed Identifier
7954760
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.
Results Reference
background
PubMed Identifier
32359776
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.
Results Reference
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"Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches"

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