Evaluating the Impact of Virtual Reality on Mood in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Essential Tremor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluation of Anxiety Levels by Visual Analogue Scale for Anxiety (VAS-A)
研究概览
简要总结
The primary objective of this randomized study is to evaluate the effect of a virtual reality (VR) video on pre-treatment anxiety levels in individuals undergoing magnetic resonance-guided focused ultrasound (MRgFUS) treatment for medication-refractory essential tremor (ET). Participants will be randomized to view one of two VR videos, and pre-treatment anxiety levels will be compared between groups.
As a secondary objective, the study will compare patient concerns (including claustrophobia, mental preparedness, and fear of pain, as well as any additional concerns identified during the study) between the two randomized groups.
详细描述
This study will evaluate the effectiveness of a virtual reality (VR) intervention in reducing preoperative anxiety among adults scheduled to undergo magnetic resonance-guided focused ultrasound (MRgFUS) for essential tremor. Sixty adult participants scheduled for MRgFUS will be randomized to view one of two 6-minute immersive VR procedural videos using a headset prior to treatment.
Preoperative anxiety will be assessed using validated self-report instruments, including the Visual Analogue Scale for Anxiety (VAS), the Amsterdam Preoperative Anxiety and Information Scale (APAIS), and the State-Trait Anxiety Inventory - State version (STAI-S). The primary objective is to compare preoperative anxiety levels between the two VR video groups. A secondary objective is to compare patient concerns between groups, including but not limited to claustrophobia, mental preparedness, and fear of pain, as well as any additional concerns identified through patient reporting.
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
- Single (Participant)
盲法说明
Participants are blinded to which of the two possible VR videos they will see.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be over the age of 18 and have been approved and consented for MRgFUS thalamotomy for medication-refractory essential tremor
- •Subjects must be and willing to give consent and able to attend all study visits and MRgFUS procedure, understanding the associated risks and benefits.
- •Participants must be willing or able to complete questionnaires or have someone who can complete them on their behalf.
排除标准
- •Patients prone to epileptic seizures and/or sensory issues will be excluded from the study.
- •Patients who have previously undergone an MRgFUS procedure (ipsilateral or contralateral to the hemisphere currently being treated) will be excluded.
结局指标
主要结局
Evaluation of Anxiety Levels by Visual Analogue Scale for Anxiety (VAS-A)
时间窗: Questionnaires will be collected at two time points: 1.Baseline assessment day (two weeks before the MRgFUS procedure), before and after watching the VR video. 2.Treatment day, prior to the MRgFUS procedure.
Participants will complete questionnaires to establish baseline anxiety levels. A 10-point numeric rating scale displayed horizontally, ranging from 0 = "Not at all anxious" to 10 = "Extremely anxious." Participants mark the number that best represents their current level of anxiety. Higher scores indicate greater anxiety.
Evaluation of Anxiety Levels by Amsterdam Preoperative Anxiety and Information Scale (APAIS)
时间窗: Questionnaires will be collected at two time points: 1.Baseline assessment day (two weeks before the MRgFUS procedure), before and after watching the VR video. 2.Treatment day, prior to the MRgFUS procedure.
Participants will complete questionnaires to establish baseline anxiety levels. The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a 12-item self-administered questionnaire used to assess preoperative anxiety. Each item is rated on a 5-point scale (1 = not at all to 5 = extremely). Higher scores indicate greater anxiety or information need. In this study, patient concerns may include anesthesia, head shaving, potential side effects and desire for additional procedural information.
Evaluation of Anxiety Levels by State-Trait Anxiety Inventory - State Subscale (STAI-S)
时间窗: Questionnaires will be collected at two time points: 1.Baseline assessment day (two weeks before the MRgFUS procedure), before and after watching the VR video. 2.Treatment day, prior to the MRgFUS procedure.
Participants will complete questionnaires to establish baseline anxiety levels. The State-Trait Anxiety Inventory - State Subscale (STAI-S) is a validated self-report questionnaire used to measure situational ("state") anxiety - how the participant feels "right now, at this moment." Each item is rated on a 4-point scale ranging from 1 = not at all to 4 = very much so. Higher scores indicating greater anxiety.
次要结局
- Participant feedback on the VR experience(Feedback will be collected at two time points: 1.Baseline assessment day (two weeks before the MRgFUS procedure), before and after watching the VR video. 2.Treatment day, prior to the MRgFUS procedure.)
- Adverse Effects Associated With Watching the VR Video(Adverse effects will be monitored at two time points: 1.Baseline assessment day (two weeks before the MRgFUS procedure). 2.Treatment day, prior to the MRgFUS procedure.)