Study of Informative Video On Alleviating Perioperative Anxiety And Improving Satisfaction Score In Obstetric Patient Undergoing Elective Lower Segment Caesarean Section Under Spinal Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- Perioperative Anxiety Level
研究概览
简要总结
Title:
"Study of Informative Video on Alleviating Perioperative Anxiety and Improving Satisfaction Score in Obstetric Patients Undergoing Elective Lower Segment Caesarean Section Under Spinal Anaesthesia"
Objective:
This study aims to evaluate the effectiveness of an informative video in reducing perioperative anxiety and enhancing satisfaction in obstetric patients undergoing elective Caesarean sections under spinal anaesthesia. The hypothesis is that patients who view the video will experience lower anxiety and higher satisfaction compared to those who receive standard pre-anaesthetic counselling alone.
Background:
Spinal anaesthesia, commonly used for Caesarean sections, offers rapid, predictable pain relief but can cause discomfort due to factors such as visceral pain and fundal pressure, leading to perioperative anxiety. Anxiety can negatively impact maternal satisfaction and increase the risk of postpartum complications. Previous studies have shown mixed results regarding the efficacy of educational videos in alleviating this anxiety.
Methods:
The study is a prospective, randomized controlled trial conducted at Universiti Malaya Medical Centre. Eligible participants are obstetric patients (ASA II-III) undergoing elective Caesarean sections. Participants are randomly assigned to either an intervention group, which receives a supplemental informative video, or a control group receiving standard care. Anxiety and satisfaction levels are assessed using validated questionnaires pre- and post-surgery.
Anticipated Outcomes:
The study hypothesizes that the informative video will significantly reduce perioperative anxiety and improve maternal satisfaction, thereby demonstrating the superiority of this intervention over standard pre-anaesthetic counselling.
详细描述
Introduction Spinal anaesthesia is the preferred method for Caesarean sections due to its high success rate and minimal impact on maternal-fetal physiology. However, it is not without discomfort, as patients remain awake and can experience visceral pain, nausea, and other sensations that contribute to perioperative anxiety and dissatisfaction. This study explores the potential of an informative video to address these issues and improve patient outcomes.
Problem Statement Despite the widespread use of educational videos, the optimal approach for reducing anxiety and improving satisfaction in Caesarean patients remains unclear. Previous videos have focused on technical aspects of spinal anaesthesia without adequately addressing potential discomforts. This study seeks to bridge this gap by emphasizing specific sources of discomfort in the video content.
Research Questions Can an informative video highlighting potential sources of anxiety and dissatisfaction effectively alleviate these issues during the perioperative period? Is the video more effective than standard pre-anaesthetic counselling alone? Hypotheses Null Hypothesis: There is no significant difference in anxiety and satisfaction between patients who view the video and those who do not.
Alternative Hypothesis: Patients who view the video will have lower anxiety and higher satisfaction levels.
Objectives Evaluate if the video effectively reduces perioperative anxiety and dissatisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The parturient will be randomly grouped into two groups which are Group V (Informative Video) and Group C (control group) using a computer-generated sequence in a permuted block of six. A research assistant/medical officer who is not involved in the conduct of study will perform the allocation concealment by placing the randomization sequence into sealed and opaque envelopes, which will be numbered accordingly. The next available envelope will be taken for the next recruited parturient and open by the investigator after the baseline anxiety level assessment is completed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All obstetric patients American Society of Anaesthesiologists (ASA) II-III
- •First time undergo elective caesarean section
- •Under spinal anaesthesia.
排除标准
- •Less than 18 years old
- •known antenatal diagnosis of morbid foetal conditions
- •history of psychiatry illness
结局指标
主要结局
Perioperative Anxiety Level
时间窗: Preoperative: Baseline anxiety levels are assessed one day before the caesarean section.Postoperative: Anxiety levels are reassessed on day 1 post-caesarean section.
The primary outcome measure is the level of perioperative anxiety experienced by patients, assessed using the Speiberger State-Trait Anxiety Inventory (STAI). This tool evaluates both state and trait anxiety levels, focusing on current anxiety experienced by patients before and after the elective lower segment caesarean section under spinal anaesthesia.
次要结局
- Maternal Satisfaction with Anesthesia and Procedure(Postoperative: Maternal satisfaction is assessed on day 1 post-caesarean section, during the same time frame as the anxiety reassessment.)
研究者
Dr Hadri Kamarrudin
Doctor
University of Malaya