Comparison of unimodal, non-pharmacological, preoperative psychological prehabilitation intervention: Nature Soundscape Immersion and Virtual reality on preoperative anxiety and stress reduction- A randomised non inferiority trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Preoperative Anxiety: Measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Scores range from 6–30, with higher scores indicating
研究概览
简要总结
Summary of the Study
Title: Comparison of unimodal, non-pharmacological, preoperative psychological prehabilitation intervention: Nature Soundscape Immersion (NSI) vs. Virtual Reality (VR) on preoperative anxiety and stress reduction – A randomized non-inferiority trial.
Background: Preoperative anxiety affects 11–80% of surgical patients, leading to adverse physiological and psychological outcomes. While pharmacological treatments exist, they have limitations like side effects and prolonged hospital stays. Non-pharmacological interventions, such as psychological prehabilitation, have shown promise in reducing anxiety and improving surgical outcomes. VR and NSI are two such methods, with VR offering immersive experiences and NSI providing cost-effective, low-risk nature sound immersion.
Objective: To evaluate whether NSI is non-inferior to VR in reducing preoperative anxiety as measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Secondary outcomes include stress, patient satisfaction, physiological parameters, and simulation sickness scores.
Study Design:
- Type: Randomized, non-inferiority trial.
- Setting: Preoperative areas, AIIMS New Delhi.
- Duration: 6 months.
- Participants: 120 adults (18–70 years) undergoing elective surgery under general anesthesia.
Intervention:
- Group A (VR): 10 minutes of calming VR visual experience.
- Group B (NSI): 10 minutes of nature sound immersion via noise-cancelling headphones.
Outcome Measures:
- Primary: Anxiety reduction (APAIS scores).
- Secondary: Stress (VAS scores), patient satisfaction, physiological parameters (BP, HR), and simulation sickness scores.
Key Features:
- Randomized allocation to groups using a 1:1 ratio.
- Blinded outcome assessment.
- Statistical analysis includes non-inferiority testing and descriptive statistics.
Ethics and Data Management: The study adheres to ethical guidelines, with written informed consent obtained from participants. Data will be anonymized and securely stored.
This trial aims to provide evidence for NSI as a practical, accessible alternative to VR for managing preoperative anxiety and stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria: Adults aged 18 to 70 years.
- •Patients scheduled for first elective surgery under general anesthesia.
- •Ability to understand and complete APAIS and VAS scales.
排除标准
- •Exclusion Criteria: Patients with visual impairments (for VR group).
- •Hearing impairments (for music group).
- •Known psychiatric conditions affecting anxiety.
- •Previous experience with VR or music therapy within 3 months before surgery.
- •Patients on preoperative anxiolytics or sedative medications.
结局指标
主要结局
Preoperative Anxiety: Measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Scores range from 6–30, with higher scores indicating
时间窗: T0- Pre intervention, T1 Post-intervention, T2- Preoperative room, T3- Postoperative Recovery room.
higher anxiety levels. This will be assessed immediately before the intervention and
时间窗: T0- Pre intervention, T1 Post-intervention, T2- Preoperative room, T3- Postoperative Recovery room.
immediately after the intervention.
时间窗: T0- Pre intervention, T1 Post-intervention, T2- Preoperative room, T3- Postoperative Recovery room.
次要结局
- Perceived Stress: Assessed using a 10-point Visual Analogue Scale (VAS), where 0 indicates no stress and 10 indicates extreme stress. This will be assessed before and after the intervention.(T0- Pre intervention, T1 Post-intervention, T2- Preoperative room, T3- Postoperative Recovery room.)
- Patient Satisfaction: Measured using a 10-point VAS to evaluate satisfaction with the anxiety-reducing intervention. This will be assessed postoperatively.(T0- Pre intervention, T1 Post-intervention, T2- Preoperative room, T3- Postoperative Recovery room.)
- Patient Vitas: Heart rate and Blood pressure using the standard monitors.(T0- Pre intervention, T1 Post-intervention, T2- Preoperative room, T3- Postoperative Recovery room.)
- Simulation Sickness score.(T0- Pre intervention, T1 Post-intervention, T2- Preoperative room, T3- Postoperative Recovery room.)
研究者
Prakash Gyandev Gondode
All India Institute of Medical Sciences, New Delhi