Official Title: Effectiveness of Virtual Reality-enhanced Interventions on Preoperative Anxiety in Adults Undergoing Elective Surgery: A 3-arm Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Preoperative anxiety
研究概览
简要总结
Brief Summary: Preoperative anxiety is a common phenomenon in surgical patients, with a pooled global prevalence of 48%. Surgical patients with preoperative anxiety may negatively impact their psychological health and surgical outcomes. Recent studies have revealed the promising effects of virtual reality-enhanced interventions to improve preoperative anxiety symptoms among adults undergoing elective surgery.
There is a lack of interventional studies to compare and evaluate the co-designed preoperative virtual reality-enhanced interventions in adult surgical patients.
This study aims to examine the effects of co-designed virtual reality educational video and virtual reality distraction video on preoperative anxiety symptoms, vital signs, Satisfaction with Life Scale (SWLS), and postoperative anxiety compared to usual care. This study will contribute by evaluating evidence-based, user-centered VIPA that may be effective for improving preoperative anxiety among adult surgical patients.
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 (Outcomes Assessor)
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
- •Age aged ≥18 years old
- •Surgical patients attending Nurse Pre-anaesthetic Assessment Clinic (NPAC)
- •American Society of Anesthesiology (ASA) physical status ASA I or ASA II
- •Able to communicate in Chinese
排除标准
- •Patients who have a cognitive, communication or physical impairment precluding their ability to complete the study
- •Patients who are prone to epilepsy or other neurological conditions
研究组 & 干预措施
Virtual Reality Group 1 (Education approach)
Participants in Virtual Reality Group 1 (Education approach) will receive a co-designed virtual reality educational 6-minute video via VR headset. The virtual reality educational video includes three main scenes, consisting of preoperative, intraoperative and postoperative content located at operating theatre reception, operating theatre, and post-anaesthetic care unit respectively.
干预措施: Virtual Reality (Other)
Virtual Reality Group 2 (Distraction approach)
Participants in Virtual Reality Group 2 (Distraction approach) will receive a virtual reality distraction 6-minute video via VR headset. The virtual reality distraction video includes immersive natural scenes with concurrent music, without educational component.
干预措施: Virtual Reality (Other)
Control Group
Participants in control group will receive usual care only.
结局指标
主要结局
Preoperative anxiety
时间窗: Baseline, Immediate post-intervention, Day of surgery
Preoperative anxiety will be measured using the Short Chinese Version of the State-Trait Anxiety Inventory (Du et al., 2022). Items are rated on a 4-point Likert scale ranging from 1 to 4, with higher scores indicating higher anxiety. The Short Chinese Version of the State-Trait Anxiety Inventory demonstrates good psychometric properties.
次要结局
- Heart rate(Baseline, Immediate post-intervention, Day of surgery)
- Blood pressure(Baseline, Immediate post-intervention, Day of surgery)
- Temperature(Baseline, Immediate post-intervention, Day of surgery)
- Life satisfaction(Baseline, Immediate post-intervention, Day of surgery, Post-operative day 7)
- Evaluation of Virtual reality-enhanced interventions questionnaire(Immediate post-intervention)
- Postoperative anxiety(Post-operative day 7)
研究者
Sin Lun CHAN
Principal Investigator
Chinese University of Hong Kong