Evaluating the Acceptability of Virtual Reality Headsets During Surgery Under Spinal Anesthesia in Elderly Patients. Seniors' Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality (SILVR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Patient's tolerance to headset
研究概览
简要总结
This study aims to evaluate the acceptability of intraoperative virtual reality in elderly patients under spinal anesthesia.
详细描述
For the past decade, virtual reality (VR) has been expanding across various medical applications fields. Regarding surgery and anesthesia, VR was used during different procedures such as orthopedics surgery of the upper extremities under regional anesthesia blocks, hip and knee arthroplasties, dental care and induction of anesthesia, especially in pediatrics. Using VR during surgery can reduce pain, anxiety, quantity of sedation used and time in the PACU.
Unfortunately, the adherence to VR specifically among adults aged 65 and over is not thoroughly defined in the scientific literature and should be investigated in order to determine the spectrum of use of this tool. However, VR has been used as an anxiolytic and analgesic in elderly patients during rehabilitation exercises, such as physiotherapy treatment after surgery or vestibular rehabilitation after experiencing dizziness.
The main objective of this study is to determine if a virtual reality headset can be tolerated during surgery under spinal anesthesia in patients aged 65 years and older. 55 patients over 65 years old having an elective surgery will be recruited.
The total time for which the patient will wear the virtual reality headset during the surgery will be measured and a semi-structured post-operative questionnaire will assess the overall patient satisfaction.
Simultaneously, the influence of the type of scenario chosen on the patient's tolerance to the VR headset will be established (secondary objective details listed below)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully consented patients over 65 years old
- •Undergoing elective surgery that requires spinal anesthesia.
排除标准
- •Hearing or visual impairment
- •History of epilepsy, seizure, or severe dizziness
- •Severe mental impairment
- •Recent eye or facial surgery or wounds
- •Inability to use their hands
结局指标
主要结局
Patient's tolerance to headset
时间窗: Intraoperative (from T0 = the patient puts on the headset until Tend = 30 minutes after T0)
The primary endpoint is the patient's tolerance to virtual reality defined by the headset to be worn for more than or equal to 30 minutes by the participant
次要结局
- Total of time before the patient's first request to interrupt the experiment(intraoperative (from T0 = the patient puts on the headset at the beginning of the surgery until Tend = the patient first asks to interrupt the experiment during the surgery, about 45 minutes - depending on the person and the surgery))
- Incidence of adverse effects(intraoperative (from T0 = the patient puts on the headset until Tend = the patient takes off the headset, about 45 minutes - depending on the surgery))
- Anxiety before the surgery(preoperative (from T0 = the patient arrives at the hospital the morning of the surgery until Tend = the patient enters the operating room, about 2 hours))
- Total of time during which the patient wears the VR headset during surgery.(intraoperative (from T0 = the patient puts on the headset and starts the initially chosen scenario until Tend = the patient takes off the headset, about 45 minutes - depending on the person and the surgery))
- Time spent on each scenario and the order in which they were presented(intraoperative (from T0 = the patient starts the first scenario until Tend = he asks to change the scenario) - for each scenario, about 45 minutes - depending on the person and the surgery)
- Patient's satisfaction(postoperative (from T0 = the surgery ends until Tend = the semi-structured questionnaire is over, about 2 hours))
研究者
Pascal Laferrière-Langlois
MD, MSc, FRQS, Assistant Professor, Principal Investigator, Anesthesiologist
Ciusss de L'Est de l'Île de Montréal