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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-03-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Migraine Disorders Virtual Reality

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type DEVICE

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

Interventions

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Virtual Reality

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No