Randomized Clinical Trial for Comparison Between the Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Anxiety Score
研究概览
简要总结
The aim is to investigate the anxiolytic effect, and hemodynamic stability of using virtual reality immersion in adult patients undergoing Dacryocystorhinostomy (DCR) operation under general anesthesia and to compare its effect to that of using Midazolam as a premedication.
详细描述
Anxiety is a negative emotion characterized by fear, tension, and nervousness. Preoperative anxiety is anxiety due to disease, hospitalization, or scheduled surgery. The most common causes of preoperative anxiety are waiting for surgery, worrying about the operation outcome, being separated from family, anticipating postoperative pain, losing independence, and being afraid of surgery, pain, and death.
Midazolam reduces anxiety by acting on GABAA receptors, resulting in sedation; however, the benefit of midazolam premedication remains debatable, and the drug's side effects include paradoxical reactions, oversedation, reduced blood pressure, and respiratory depression. Regarding this, some clinicians challenge the clinical benefits of benzodiazepine premedication and contend that non-pharmacological treatments alone are sufficient to minimize preoperative anxiety.
Virtual reality is a computer technology that creates the sensation of being immersed in a simulated three-dimensional environment in which the user can interact with the virtual environment. It has also been suggested as a non-pharmaceutical alternative for lowering surgical pain and anxiety.
Dacryocystorhinostomy (DCR) is a procedure that circumvents the blocked tear duct and offers an alternate path for the drainage of tears from the eye to the nose and is most effectively performed under a general anesthetic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes.
- •American Society of Anesthesiologists (ASA) classification: I - II.
- •Patient undergoing Dacryocystorhinostomy Surgery (DCR) operation under general anesthesia.
排除标准
- •Patient refusal.
- •Patients with cardiac diseases.
- •Patients with renal diseases.
- •Patients with drug sensitivity and seizures.
- •Substance abuse and addiction.
- •Claustrophobia.
- •Patients with cerebrovascular disease.
- •Psychiatric and cognitive disorder.
- •Patients with severe teary eyes and blurring of vision.
- •Patients who express discomfort during the test.
研究组 & 干预措施
Virtual Reality Group
Patient will undergo virtual reality (VR) immersion using oculus.
干预措施: Virtual Reality Group (Other)
Midazolam Group
Patient will receive midazolam premedication only.
干预措施: Midazolam Group (Drug)
结局指标
主要结局
Anxiety Score
时间窗: 15-minute after intervention
Beck Anxiety Inventory (BAI) score change measured from pre- to post-intervention (virtual reality (VR) or midazolam). The score ranges from 0 to 63. A greater reduction indicates better anxiolytic effect.5 minutes before intervention and Immediately after the 15-minute virtual reality (VR) session or midazolam injection
次要结局
- Patient Satisfaction(2 hours Post intervention)
- Systolic blood pressure (SBP)(After intubation (Up to 2 hours))
- Diastolic blood pressure (DBP)(After intubation (Up to 2 hours))
- Heart rate (HR)(After intubation (Up to 2 hours))
- Mean blood pressure (MBP)(After intubation (Up to 2 hours))
- Incidence of Complications(First 30 minutes post-extubation)
研究者
Hebatallah Salah Abdelhamid
Lecturer of Anesthesia, Surgical Critical Care and Pain Management Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
Cairo University
