Analyzing the Impact of Preprocedural Video Demonstration for Patients Undergoing Epidural Analgesia - An Interventional Study on Patient Experience, Anxiety, and Perceived Efficacy.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- 1. Anxiety Levels
研究概览
简要总结
This prospective interventional study seeks to investigate the impact of preprocedural video demonstrations on patient satisfaction, anxiety levels, and doctors’ perceived efficacy within the context of epidural analgesia procedures. Patients scheduled for epidural analgesia will be randomly assigned to either the intervention group, which will receive a comprehensive preprocedural video explaining the procedure, its benefits, and potential risks, or the control group, which will receive a sham video instead of the comprehensive interventional video. The sham video is what we use regularly to educate patients regarding anesthesia in the pre-anesthetic Clinic.
Data collection will comprise the use of standardized questionnaires. Anxiety levels will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS), a validated tool measuring patients’ emotional state and information needs. Patient satisfaction will be evaluated using a Likert scale, focusing on overall satisfaction and the quality of information that the healthcare team provides. Additionally, doctors’ perceived efficacy will be examined through structured questionnaires, which reflect their procedural effectiveness.
The data will be analyzed using appropriate statistical methods like t-tests, chi-square tests, or analysis of variance (ANOVA) to compare outcomes between the intervention and control groups. This analysis aims to uncover the impact of the preprocedural video intervention on patient anxiety levels, satisfaction, and doctors’ perceived efficacy during epidural analgesia procedures.
The significance of this study lies in its potential to provide valuable insights into the patient experience during epidural analgesia procedures. Ultimately, the study’s findings may contribute to improved patient outcomes, increased procedural efficiency, and the advancement of patient-centered care in the field of epidural analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
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: Age: Participants must be within the age range of 18 to 65 years.
- •Diagnosis/Indication: Participants scheduled for epidural analgesia undergoing various surgical procedures.
- •Position: Must be able to sit upright.
- •BMI: BMI should be less than 35 Procedure: Thoracic and lumbar Epidural Procedures.
- •Ability to understand and Provide Informed Consent: Participants should possess stable mental health.
- •Healthcare Providers: Healthcare providers involved in administering epidural analgesia (Anaesthesiologists and senior anaesthesiology residents).
排除标准
- •Patients: Age Limitations: Participants must be within the age range of 18 to 65 years.
- •BMI: BMI greater than 35 Contraindications to Epidural Analgesia: Individuals with active infections, bleeding disorders, severe allergies, or other conditions that pose risks to the procedure will be excluded from participation.
- •Other Health conditions: Pregnancy, Previous surgery, and abnormal anatomy in the back.
- •Pre-existing Severe Anxiety or Psychiatric Conditions.
- •Inability to Provide Informed Consent: Those who are comatose, low GCS, or mentally unstable patients will be excluded.
- •Prior Experience: Participants with prior experience with epidural analgesia will be excluded.
- •Healthcare Providers: Healthcare providers who do not have sufficient experience in performing epidural analgesia procedures.
结局指标
主要结局
1. Anxiety Levels
时间窗: Time Frame: 12 months from time of | randomization
次要结局
- 1. Patient Satisfaction(2. Doctors Perceived Efficacy)
研究者
Pradeepa C
Christian Medical College, Vellore