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临床试验/NCT06061588
NCT06061588已完成不适用

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

Ankara City Hospital Bilkent2 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2023年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Visual Analogue Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Visual Analogue Scale

时间窗: 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

时间窗: 120.minute

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

次要结局

  • Side effects(120.minute)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Safa Dönmez

M.D.

Ankara City Hospital Bilkent

研究点 (2)

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