Migraine Disorders, Virtual Reality
Conditions
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 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.
Interventions
DEVICEVirtual Reality
The use of virtual reality as an adjunct to routine treatment.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 0. -15. -30.-60.-120. minutes | 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. |
| Rescue analgesic use | 120.minute | For patients with a VAS score 50mm or higher at 120.minute rescue therapy was planned. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | 120.minute | The difference between two groups observed in terms of side effects were recorded. |
Countries
Turkey (Türkiye)
Outcome results
None listed