Virtual Reality for the Management of Pain and Anxiety for Outpatient Interventional Radiology Procedures Performed With Local Anesthesia: A Randomized Pilot Study in Digital Sedation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Pain (VAS)
研究概览
简要总结
This study explores the use of virtual reality (VR) to reduce pain and anxiety during thyroid biopsies and PICC line insertions under local anesthesia. One group experienced the procedure with VR, while the other group did not. Participants completed questionnaires before and after the surgery to measure pain and anxiety levels. The main goal is to observe if VR can significantly decrease pain and anxiety during these procedures.
详细描述
This prospective, randomized, controlled study investigates the efficacy of virtual reality (VR) as a means to alleviate pain and anxiety in individuals receiving thyroid biopsies and PICC placements with local anesthesia. This study was conducted at Temple University Hospital between June 2021 and August 2022. A total of 107 patients were randomized into treatment and control groups. The VR experience involved wearing a headset with an immersive 3D visual display and accompanying music, simulating a calming environment. Patients completed Visual Analog Scales for pain and anxiety both before and after the intervention, reflecting their pain and anxiety levels prior to and during the procedure. The primary endpoints were to observe the effect of VR on pain and anxiety in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Age over 18
- •Scheduled to receive Fine-Needle Aspiration (FNA) Thyroid Biopsy
- •Scheduled to receive Peripherally Inserted Central Catheters (PICC)
排除标准
- •Declining to participate
- •Inability to provide consent
- •Emergency procedures
- •Administration of general anesthesia/moderate sedation
- •Visual or hearing deficits
- •Pregnancy
- •Current prisoner status
- •Nerve or sensory deficits over area of procedure
- •COVID-19 positive status
结局指标
主要结局
Pain (VAS)
时间窗: Immediately prior to and after procedure
Pre-procedure pain assessments were obtained using a Visual Analog Scale (VAS) corresponding to the patient's expected level of pain during each procedure prior to randomization to treatment or control. VAS scale was measured in mm, 0mm indicating "no pain", 100mm indicating "worst pain." Following each procedure, participants completed a self-reported survey indicating actual pain felt during procedure on VAS scale.
Anxiety (VAS)
时间窗: Immediately prior to and after procedure
Pre-procedure anxiety assessments were administered using a VAS scale to indicate the patient's level of anxiety prior to randomization to treatment or control. Similar to pain, VAS anxiety scale was measured in mm, 0mm indicating "no anxiety", 100mm indicating "worst anxiety." Following each procedure, participants completed a self-reported survey indicating actual level anxiety experienced during the procedure on VAS scale.
次要结局
- Diastolic Blood Pressure (mmHg)(Three times during procedure)
- Lidocaine Administered(Immediately after procedure)
- Procedure Length(Duration of procedure)
- Systolic Blood Pressure (mmHg)(Three times during procedure)
- Pulse Rate (bpm)(Three times during procedure)