A Randomized Control Study comparing the effect of intraoperative external audiovisual blockade, immersive distraction and standard care on anxiety, stress and pain catastrophizing score in parturients undergoing caesarean delivery under spinal anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in anxiety scores using Novel Visual Facial Anxiety (NVFAS) from baseline to 2 hours post operatively among the three groups.
研究概览
简要总结
High levels of stress and anxiety before or during caesarean delivery may increase the prospects of anaesthesia related complications during surgery, increase postoperative analgesic requirement, prolong recovery time, delay lactation and have a relatively higher risk of developing behaviour problems in their children during preschool period. It is thus imperative to decrease caesarean delivery related stress and anxiety.
Various interventions have been used for reduction of anxiety and stress. The aim of our study is to evaluate and compare the effect of intraoperative external audiovisual blockade, immersive distraction and standard care on anxiety, stress and pain catastrophizing score in parturients undergoing caesarean delivery under spinal anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients of American Society of Anaesthesiologists (ASA) Physical Status II, III.
- •Singleton pregnancy.
排除标准
- •Severe preclampsia, eclampsia.
- •Significant hepatic, renal and cardiovascular disease.
- •Significant vision and hearing impairment.
- •History of generalized anxiety disorder or mental illness
- •Contraindication to spinal anaesthesia.
- •Any psychiatric/ cognitive disorder affecting anxiety and pain assessment.
- •Patients in active labour.
- •Known history of seizures, migraine, motion sickness, claustrophobia.
结局指标
主要结局
Change in anxiety scores using Novel Visual Facial Anxiety (NVFAS) from baseline to 2 hours post operatively among the three groups.
时间窗: 1. After shifting to OT. | 2. Two hours post operatively.
次要结局
- Change in anxiety scores using Novel Visual Facial Anxiety (NVFAS) from baseline to the end of surgery and 6 hours post-operatively among the three groups.(1. After shifting to OT.)
- Change in stress scores using Brief Measure Of Emotional Perioperative Stress (BMEPS) at different time points.(1. After shifting to OT.)
- Change in total and subgroup pain catastrophizing score using Pain Catastrophizing Scale (PCS) at different time points.(1. After shifting to OT.)
- Change in serum cortisol, serum IL-6, neutrophil lymphocyte ratio and salivary cortisol levels at different time points.(Serum cortisol, Serum IL-6 and neutrophil lymphocyte ratio at pre-operatively and 6 hours post operatively.)
- Change in acute pain scores using Numerical Rating Scale (0-10) at different time points.(1. After shifting to OT.)
- Patient satisfaction questionnaire score and feedback regarding intervention.(2 hours postoperatively.)
研究者
Dr Shaivya Srivastava
Maulana Azad Medical College