Active vs. Passive Virtual Reality for Reducing Pain and Anxiety During Office-based ENT Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Post-Procedure Pain Assessed Using the Visual Analog Scale
研究概览
简要总结
The purpose of this research is to evaluate whether active virtual reality reduces pain and anxiety more effectively than passive virtual reality during office-based ENT procedures. The main procedures include exposure to virtual reality (passive calming scenery or interactive puzzle game) via Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures, participant self-report surveys (GAD-7, PHQ-9, PEG, VAS, SUDS, Likert, experience questions), and physician post-procedure survey. The study will enroll individuals 18 years or older who are scheduled to undergo common office-based ENT procedures (turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation, nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection) at Cedars-Sinai.
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
- None
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
- •Active and Passive VR:
- •Individuals 18 years old and older are included
- •Individuals undergoing the following common office-based ENT procedures: turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation (RhinAer/VivAer), nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection
- •Able to consent
- •English speaking
排除标准
- •History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, vertigo, or inability to use a handheld controller
- •Any records flagged "break the glass" or "research opt out."
- •Exclusion Criteria Passive VR:
- •History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, or vertigo
- •Any records flagged "break the glass" or "research opt out."
研究组 & 干预措施
Passive virtual reality
passively watching calming scenery
干预措施: Passive virtual reality headset or goggles (Device)
Active virtual reality
interactive game
干预措施: Active virtual reality headset or goggles (Device)
结局指标
主要结局
Post-Procedure Pain Assessed Using the Visual Analog Scale
时间窗: Immediately after the office-based ENT procedure
Post-procedure pain will be assessed using the Visual Analog Scale, ranging from 0 to 100 mm, where 0 mm indicates "no pain" and 100 mm indicates "worst imaginable pain." Higher scores indicate greater pain.
Post-Procedure Anxiety Assessed Using the Subjective Units of Distress Scale
时间窗: Immediately after the office-based ENT procedure
Post-procedure anxiety will be assessed using the Subjective Units of Distress Scale, ranging from 0 to 100, where 0 indicates "totally relaxed" and 100 indicates "highest distress/fear/anxiety/discomfort that you have ever felt." Higher scores indicate greater distress.
次要结局
- Clinician Experience with Virtual Reality Use(Immediately after the office-based ENT procedure)
研究者
Dennis Tang
Physician ENT
Cedars-Sinai Medical Center