The Impact of Virtual Reality -Guided Visual and Auditory Therapy on Symptom Severity and Psychological Well-Being in Tension-Type Headache Patients: A Controlled Study
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
- Reduction in Pain Intensity Measured by Visual Analog Skala (VAS)
研究概览
简要总结
The primary aim of this research is to objectively assess the impact of virtual reality (VR) technology on pain symptoms in tension-type headache patients. This study is designed to understand the potential of VR in the treatment of tension-type headaches, exploring its ability to reduce pain severity and improve patients' quality of life.
详细描述
Tension-type headache is a prevalent health issue that can cause significant discomfort to patients. The potential use of VR goggles as an effective alternative treatment option in these patients is crucial in clinical applications. The quality of life of tension-type headache patients is often affected. If VR goggle technology can enhance the quality of life for these patients, it would be a significant finding.
Additionally, our research may contribute more data to the scientific literature on the impact of VR goggle technology in headache treatment. This could assist future researchers in designing similar studies and better understanding the results. If VR goggle technology proves effective, it could contribute to diversifying treatment options for tension-type headache patients and improving access to treatment.
The primary objective of the study is to investigate the effect of virtual reality therapy on pain symptoms in tension-type headache patients. If the results are positive, VR technologies may alleviate pain and enhance the quality of life for these patients. It could also help them function better in their daily lives. If relaxation is found to be effective in the VR group, a new treatment option would be introduced for tension-type headache patients. This could contribute to the diversification of treatment options.
The study poses no risk to the patient. The patient will lie on the bed, and the VR goggles will be used accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •Patients between the ages of 18 and 65
- •Patients meeting the criteria for Tension-Type Headache (TTH) in the third edition of the International Classification of Headache Disorders
- •Patients willing to participate in the study
- •Patients indicating a VAS score of 50 and above
- •Patients without other suspected diagnoses
- •Patients with no known history of adverse reactions to the active ingredients of the drugs to be used
- •Conscious patients
- •Patients who are oriented and cooperative
排除标准
- •Patients under the age of 18 and over the age of 65
- •Patients who do not consent to participate in the study
- •Patients with vital signs outside normal limits
- •Patients with a history of adverse reactions to known NSAIDs
- •Individuals unable to determine pain intensity on the VAS
- •Patients with a VAS score of 50 mm and below
- •Pregnant individuals
- •Those with advanced systemic diseases
- •Patients with malignancies
- •Individuals with chronic liver and kidney diseases
- •Those using sedative and analgesic neuro-psychiatric drugs
- •Individuals with a history of psychological and neurological diseases
- •Patients who used analgesics within 8 hours before the examination
结局指标
主要结局
Reduction in Pain Intensity Measured by Visual Analog Skala (VAS)
时间窗: Baseline (VAS-0) to 30th, 60th, and 120th minutes post-treatment.
Change in pain intensity was assessed using the Visual Analog Scale (VAS), where participants rated their pain on a scale from 0 mm (no pain) to 100 mm (worst pain ever experienced). The primary outcome was the change in VAS scores from baseline (VAS-0) to subsequent time points (VAS-30, VAS-60, and VAS-120), calculated as ΔVAS and ΔVAS% for each interval.
次要结局
- Mood Improvement Measured by Likert Scale(Baseline to the 120th minute post-treatment.)
- Occurrence of Side Effects(From baseline to the 120th minute post-treatment.)
研究者
Safa Dönmez
Principal Investigator
Ankara City Hospital Bilkent