Comparative evaluation of preoperative virtual operating room tour vs meditation music in allaying preoperative anxiety A prospective openlabel randomized controlled endpoint blinding study.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Decrease in preoperative anxiety levels more with Virtual operating room tour (VORT), in comparison with meditation music and nil intervention
研究概览
简要总结
Fear and anxiety are very common in patients prior to surgery with anaesthesia. This preoperative anxiety is considered as normal patient response and occurs in response to surgical stress. It can lead to additional discomfort, increased pain sensation, increased stress symptoms, leading to psychological and physiological changes such as tachycardia, hypertension, risk of bleeding, poor surgical outcomes and patient satisfaction.
Pharmacological interventions have been used to manage preoperative anxiety but have their own drawbacks and can lead to prolonged hospital stay. In recent years, Virtual reality(VR) have become increasingly popular alternative approach to manage preoperative anxiety.
VR is a computer technology that provides the feeling of being immersed in a simulated three dimensional(3D) world where the user may interact with the virtual environment. It is reported that VR therapy results in significantly reduced anxiety, faster wound healing, and improved neurohabilitation outcomes. Patients will be exposed to the virtual operation room and experience the surgical environment in advance through VR. This allows patient to become familiar with fearful situations reducing preoperative anxiety.
Aim: To evaluate whether Virtual Operating Room Tour(VORT) reduces preoperative anxiety in comparison with meditation music therapy in adult patients undergoing major elective surgeries.
Objectives:
Primary objective: To compare the reduction in anxiety levels between VORT and meditation music therapy; that means to investigate whether a VORT before surgery can be used to reduce preoperative anxiety.
Secondary objective:
-
To assess the effect of VORT on the patient’s preoperative hemodynamic parameters.
-
To assess patient satisfaction with VORT and their wish to experience virtual reality in case for future surgery.
Materials and methods - A prospective, open-label, randomized controlled, end-point blinding study.
Sample size: 90 in each group.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients belonging to ASA physical status 1 and 2, giving informed, valid and written consent, undergoing elective major surgery under general and regional anaesthesia.
排除标准
- •Known mental health disorders, claustrophobia, blindness, deafness, severe visual disorders, heart diseases, history of cerebral vascular accident, emergency surgery, neurosurgery, motion sickness, vestibular dysfunction, COPD, substance abuse, GCS score less than 15.
结局指标
主要结局
Decrease in preoperative anxiety levels more with Virtual operating room tour (VORT), in comparison with meditation music and nil intervention
时间窗: -Preoperative | -10 minutes before surgery | -On table in operating room before induction of anaesthesia
次要结局
- Patient satisfaction with Virtual Operating Room Tour(VORT)(During follow-up in the evening on the day of surgery)
研究者
Vishal Patil
Karnataka Institute of Medical Sciences Hubballi