Anxiolytic Effectiveness of Virtual Reality Glasses in Upper Extremity Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- State-Trait Anxiety Scale
研究概览
简要总结
Regional anesthesia allows surgery without affecting the patient's level of consciousness.However, this may cause anxiety in some patients.In previous research, scientists have tried to prevent anxiety with non-pharmacological interventions such as music and cognitive therapies.Virtual reality is thought to offer an immersive experience that can alter the mind's perception of pain. Scientists have found in previous preliminary studies that virtual reality is safe and effective as an adjunct to standard sedative/analgesic protocols for reducing patients' pain and anxiety during endoscopy, colonoscopy, dental treatments, burn dressings, and labor. In this study, it is expected that anxiety scores, postoperative analgesic need and intraoperative sedation need will decrease, recovery quality will improve and patient satisfaction will increase in patients who will undergo upper extremity surgery under regional anesthesia and watch videos through VR glasses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •who will undergo upper extremity surgery under regional anesthesia
排除标准
- •being under 18 years old
- •Those who do not have the ability to read, understand and sign the consent form
- •An active infection or open wound in the face or eye area
- •History of seizures due to an epileptic condition or any other reason
- •Planning to wear a hearing aid during the surgical procedure
- •Having a pacemaker or other implanted medical device
- •Having an infectious condition that is transmitted through droplets or airborne
- •not knowing Turkish
- •Not deemed suitable for the approach by the surgeon
- •History of psychosis or claustrophobia
- •Being visually and/or hearing impaired
研究组 & 干预措施
Standart Anesthesia management
In the non-VR group, the standard anesthesia procedure will be followed. Brachial plexus nerve block will be performed with a 50mm peripheral block needle (Vygon echoplex+ 22Gx50mm) with a mixture of 2% lidocaine and 0.5% bupivacaine (10 mL each) prepared as 20ml. After waiting for a sufficient time, the nerve block effectiveness of the patients will be measured by Modified Broomage scale and pinprick. Additional sedative agents may be applied to both groups at the discretion of the anesthesiologist and will be recorded. Anesthesia management will be applied to both groups in accordance with the standard working order of the Anesthesia clinic.
干预措施: No VR (Other)
VR group
Oculus Quest 2 VR virtual reality glasses and wired over-ear headphones will be used for patients to hear the sounds of the immersive environment and to block the sounds coming from the operating room environment. Brachial plexus nerve block will be performed with a 50mm peripheral block needle (Vygon echoplex+ 22Gx50mm) with a mixture of 2% lidocaine and 0.5% bupivacaine (10 mL each) prepared as 20ml. After waiting for a sufficient time, the nerve block effectiveness of the patients will be measured by Modified Broomage scale and pinprick.Additional sedative agents may be applied to both groups at the discretion of the anesthesiologist and will be recorded. Anesthesia management will be applied to both groups in accordance with the standard working order of the Anesthesia clinic.
干预措施: Oculus Quest 2 VR virtual reality glasses and wired over-ear headphones (Device)
结局指标
主要结局
State-Trait Anxiety Scale
时间窗: Preoperative, Postoperative 4.hour
preoperative and postoperative STAI I and II score questions will be asked.
次要结局
- heart rate(Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour)
- The quality of recovery-15 (QoR-15)(Preoperative, Postoperative 24.hour)
- systolic blood pressure(Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour)
- diastolic blood pressure(Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour)
- mean arterial pressure(Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour)
- Surgeon satisfaction scale(Postoperativ 1.hour)
- oxygen saturation(Preoperative, İntraoperative 0 min, İntraoperative 60min, End of Operation, Postoperative 4.hour)
- aditional analgesic requirement(postoperative up to 24 hour)
- VAS score(Postoperative 1.hour, 4.hour., 12.hour., 24hour.)
- Patient satisfaction scale(Postoperative 4.hour)
研究者
Burak NALBANT
assistant professor
Ankara City Hospital Bilkent