Virtual reality versus routine care for decreasing perioperative anxiety in women undergoing gynecological surgeries under general anesthesia: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess difference in pre and postoperative anxiety in both groups by State Trait anxiety inventory
研究概览
简要总结
Introduction
Women often experience higher levels of anxiety compared to men, extending from the preoperative phase through to the postoperative period. This gender disparity in preoperative anxiety can be due to various factors such as biological variances and societal expectations. Women may face additional stressors related to reproductive health issues or gender-specific surgeries. Therefore, it is important to address perioperative anxiety to optimize patient care and improve surgical outcomes
Numerous distraction methods have been found effective in reducing anxiety, alleviating pain, and improving patient satisfaction. Among these methods, Virtual reality is one. Virtual reality provides a distraction from stress and pain and gives a sense of calmness and relaxation, by immersing patients in digitally created environments. Studies have been conducted to investigate the efficacy of virtual reality in reducing intraoperative anxiety, but research examining its effectiveness in addressing postoperative anxiety is currently lacking.
Study methodology
After recruitment, the eligible patients will be randomized by simple randomization by computer-generated number codes. The allocation to either the Virtual Reality intervention group or the Control group will be informed over telephone to the researcher by a third person not directly involved in the study. The VRI group will be educated and exposed to VR headsets. They’ll have the option to select videos from categories like forests, underwater scenes, the solar system, and religious themes. They will be explained about touch indications for posturing, attaching monitors, cleaning and draping, and giving injections during preoperative PAC and an education pamphlet will be given.
The night before surgery, patients of both the groups will be advised Tablet Alprazolam 0.25mg as per institute protocol. On the day of surgery, preoperative anxiety will be assessed by State-Trait Anxiety Questionnaire 45 minutes before shifting to the operation theatre in both groups by a blinded third person.
To the VRI group, a VR headset will be applied 30 minutes before shifting to OT and continued till a fixed dose of Injection Propofol 1.5 – 2.5mg per kg iv is given. If epidural anesthesia is administered, it will be accompanied by virtual reality intervention. After extubation, once the patient fully regains consciousness and is not drowsy, consent will be taken to reapply the virtual reality headset. If they agree, it will be started. If not, they will be asked again in the Post-Anesthesia care unit. If they agree, it will continue for one hour. The used VR is PROCUS One X VR Headset 42mm lenses.
The Control group will undergo routine perioperative management.
Both group patients will be induced with general anesthesia following the standard method which includes preoxygenation, pre-induction with fentanyl 2-3mcg per kg, induction with propofol 1.5-2 mg per kg, neuromuscular blocking agent vecuronium 0.1mg per kg, maintenance by isoflurane MAC 0.9 to 1.0. The Patient will be extubated after administration of neostigmine and glycopyrrolate to reverse the effect of neuromuscular blockade. Antiemetic prophylaxis Dexamethasone 0.1mg per kg will be given during pre-induction and ondansetron 0.1mg per kg will be given at the end of surgery. If the patient complains of nausea and vomiting in PACU Metoclopramide 10mg will be given. Injection Tramadol 1 mg per kg in 100ml NS will be given if VAS more than 4.
After one hour of complete consciousness restoration in the Post-Anesthesia Care Unit, both study groups will undergo assessment for postoperative anxiety using the STAI questionnaire and evaluation of patient satisfaction by a third-party blinded assessor. Additionally, anesthetist satisfaction will be assessed using a five-point Likert scale.
Mean Blood pressure and heart rate will be measured at the following points: Preop, pre and post epidural, after propofol administration, after intubation first three readings at 3-minute intervals, and in PACU at 5 minutes, 30 minutes, and 60 minutes.
In PACU injection Tramadol 1mg per kg in 100ml NS will be given if VAS more than 4.
Anesthetists will receive training on how to properly apply and adjust the VR headset for the patient.
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 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA 1 and 2 Aged 18 to 70 years Undergoing elective gynecological procedures Under general anaesthesia.
排除标准
- •ASA grades 3,4,5,6 Refusal for participation History of psychiatric illness Patient needing ICU backup Hearing and vision disabilities Claustrophobic.
结局指标
主要结局
To assess difference in pre and postoperative anxiety in both groups by State Trait anxiety inventory
时间窗: Pre operative anxiety assessed 45 min before shifting to OT. | Post operative anxiety assessed in PACU just before shifting patient to ward
次要结局
- To compare mean blood pressure and heart rate at following points-preop, pre and post epidural, after propofol administration at 3 minute time intervals after intubation and in PACU at 5 min, 30 min and 60 min(After Propofol administration at 3 minute time intervals after intubation for first 3 readings and in PACU at 5 min, 30 min and 60 min)
- To identify percentage of patients denying VR perioperatively(Perioperative period)
- To compare rescue analgesia required in PACU among groups(Post operative period)
- To compare patient and anesthetist satisfaction scores among groups(Post operative period)
研究者
Dr Shubha Vijay Nayak
AIIMS Bhubaneswar