AzTrials
AzTrials

Migraine DisordersNCT06061588

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

A study testing Virtual Reality in people with Migraine Disorders and Virtual Reality, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Disorders, Virtual Reality
What is being tested?
Virtual Reality
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2023to 10 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • No known adverse history to the active ingredient of the medication to be used
  • Conscious
  • Cooperatively oriented

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara City Hospital

    Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Virtual Reality
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual RealityDevice

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

Study groups in NCT06061588
Study groupRoleWhat they receive
The case groupNo interventionIncluded 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 groupExperimentalThe 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).
Receives: Device: Virtual Reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Rescue analgesic use

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

    Measured: 120.minute

Secondary outcomes (1)

  1. Side effects

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

    Measured: 120.minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2023
  2. Study start15 Sep 2023
  3. Primary completion10 Mar 2024
  4. Study completion10 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06061588
Sponsor's protocol ID
Virtual Reality in Migraine
Status last verified
May 2024
First submitted
23 Sep 2023
Last updated
6 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 37408348

  • 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.

    PubMed 35414614

  • 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.

    PubMed 35397973

  • 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.

    PubMed 15307520

  • 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.

    PubMed 7954760

  • 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.

    PubMed 32359776

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality in people with Migraine Disorders and Virtual Reality, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (time frame: 0. -15. -30.-60.-120. minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06061588, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in