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

Ankara City Hospital

Status: Completed

Conditions: Migraine Disorders; Virtual Reality

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT06061588

Virtual Reality in Migraine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

The case group

No Intervention group

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

Experimental group

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).

Treatment:

Device: Virtual Reality