A randomized crossover trial to assess the effectiveness of virtual reality on pain and anxiety during vascular cannulation among patients undergoing maintenance hemodialysis at AIIMS, New Delhi.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
This study aims to evaluate the effectiveness of virtual reality as a non-pharmacological intervention to reduce pain and anxiety during vascular cannulation in hemodialysis patients.
This study will use a Quantitative, Randomized crossover trial design among patients undergoing arteriovenous fistula cannulation for maintenance hemodialysis in the dialysis unit at All India Institute of Medical Sciences, New Delhi.
Intervention:
Group 1: VR intervention using the Oculus Quest 2 headset with calming, nature-themed 3D videos during vascular cannulation.
Group 2: Standard care involving routine cannulation procedures.
Groups will switch interventions after a two-week washout period.
Outcomes: Pain (Numeric Pain Rating Scale), anxiety (Visual Analogue Scale for Anxiety), physiological parameters (e.g., HR, BP, RR, SpO2), and patient satisfaction.
Collected data will be analysed through descriptive and inferential statistics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Patients aged between 18 and 75 years.
- •b) Patients undergoing maintenance hemodialysis 3 times in a week.
- •d) Patients who are willing to participate in the study and provide informed consent..
- •e) Patients have an orientation to time, person, and place.
- •f) Patient having sufficient vision and hearing capabilities (ability to see images with or without glasses and hear sounds from a distance of at least half a meter).
排除标准
- •a) Patient had seizure episodes within the last 6 months.
- •b) Patient having difficulty in speaking.
- •c) Claustrophobia d) Patients with a known history of cybersickness.
- •e) Patient received analgesic within 6 hours before of vascular cannulation.
结局指标
主要结局
Pain
时间窗: 1. Expected pain during vascular cannulation will be assessed before intervention. | 2. Pain experienced during vascular cannulation will be assessed immediately once procedure is completed and virtual headset device is removed.
次要结局
- Anxiety(1. Pre procedural anxiety before intervention)
- Physiological parameters which includes various components i.e. heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), respiration rate (RR), saturation of peripheral oxygen(spo2).(1. Before intervention)
- Patient satisfaction with virtual reality(1. 10 minutes after vascular cannulation)
研究者
Amit mann
All India Institute of Medical Sciences, New Delhi