Effect of use of preoperative multimedia on perioperative anxiety in patients undergoing abdominal and lower limb surgeries in spinal anaesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To study the effect of use of preoperative multimedia on perioperative anxiety in patients undergoing abdominal and lower limb surgeries in spinal anaesthesia in the age group of 18-60 years.
研究概览
简要总结
The title of the study is Effect of use of Preoperative multimedia in perioperative anxiety in patients undergoing abdominal and lower limb surgeries in spinal anaesthesia. 100 patients satisfying the above mentioned inclusion and exclusion criteria and undergoing abdominal and lower limb surgeries in spinal anaesthesia after obtaining the ethical committee clearance are included in the study. Sample size was calculated using previous similar study to detect a clinically significant difference in patients anxiety scores between groups, of >5 points to achieve power of 80% and error of 5%. 100 patients are randomly divided into 2 groups based on computer generated randomisation. After proper pre-anaesthetic workup of both the groups, first group will be shown the multimedia video and second group will be briefed verbally. Anxiety will be assessed in both the groups before the surgery and during the surgery using STAIT AND TRAIT ANXIETY SCORING SYSTEM (ranges from 20-80 points).
No or low anxiety: 20-37
Moderate anxiety: 38-44
High anxiety: 45-80
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients undergoing abdominal and lower limb surgeries under spinal anaesthesia, with intra operative supine position during surgery.
- •2 Age- 18 years to 60 years.
- •3 Sex- both male and female.
- •4 Belonging to ASA Grade I/II/III.
排除标准
- •1 Patient refusal.
- •2 Patients who have impaired vision/hearing in either or both eyes/ears respectively or are deaf in either or both ears.
- •3 History of mental illness (cognitive impairment).
- •4 Associated head ( traumatic brain injury), pelvic injuries.
- •5 Any contra-indications of spinal anaesthesia (bleeding diathesis, infection of overlying skin etc.) 6 Patients undergoing surgery above umbilicus.
- •7 Any patient having undesired sensory and motor block.
结局指标
主要结局
To study the effect of use of preoperative multimedia on perioperative anxiety in patients undergoing abdominal and lower limb surgeries in spinal anaesthesia in the age group of 18-60 years.
时间窗: Baseline( a day prior to surgery) and 10 minutes after giving spinal anaesthesia
次要结局
- 1 To compare the use of rescue(analgesic drugs.)
研究者
Divya Khobar
Institute of Medical Sciences, Banaras Hindu University