Animated Procedure Video Reduces Pain and Anxiety Among Pediatric Patients Undergoing Pin Removal Following Supracondylar Fracture Fixation - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Children's Anxiety Meter-State (CAM-S)
研究概览
简要总结
Assessing the reduction in pain and anxiety by the use of showing an animated video of the procedure, among pediatric patients undergoing pin removal after fixation of supracondylar fractures.
详细描述
Supracondylar fractures requiring K-wire fixation ultimately undergo pin removal after fracture fixation. This is a cause of pain and anxiety to children. This study aims to curtail the aforementioned troubles by distracting the patient using an animated video of the procedure. Patients will be randomized into two arms, and pain and anxiety scales will be implemented before, during, and after the procedure to assess whether a change exists between the two arms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with supracondylar fractures operated on for percutaneous K-wire fixation.
- •Age between 4 to 12 years
排除标准
- •Any syndromic patients
- •Patients having any visual or cognitive disability
- •Patients having any pre-operative or post-operative complications before pin removal.
- •Patients undergoing the procedure under general anesthesia.
- •Age <4 or >12
结局指标
主要结局
Children's Anxiety Meter-State (CAM-S)
时间窗: Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.
The Children's Anxiety Meter-State scale will be used to assess anxiety before, during, and after the procedure being performed. This is a brief measure where scores are on a scale of 0-10; low scores depict better outcomes and high scores depict worse outcomes.
Wong Baker Pain scale (WBS)
时间窗: Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.
The Wong Baker Pain scale will be used to assess pain before, during, and after the procedure being performed. A self-assessment tool for pain that uses six cartoon faces to grade pain on a numerical range of 0-10 ranked in increasing order of pain. Higher scores depict worse outcome and increased pain.
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
时间窗: Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.
Children's Hospital of Eastern Ontario Pain Scale will be used to assess pain before, during, and after the procedure being performed. A 10-item observational tool used to assess postoperative pain from a score of 4 to 13, higher scores indicating more pain and worse outcome.
Children's Anxiety Meter-State (CAM-S)
时间窗: Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.
The Children's Anxiety Meter-State scale will be used to assess anxiety before, during, and after the procedure being performed. This is a brief measure where scores are on a scale of 0-10; low scores depict better outcomes and high scores depict worse outcomes.
Short State Trait Anxiety Inventory Scale (STAI)
时间窗: Evaluation will be done as per the criteria before, during the standard procedure, and 60 minutes post-procedure.
The Short State Inventory Scale will be used to assess anxiety before, during, and after the procedure being performed, using the questionnaire set by the scale itself. A 20-item self reported assessment tool which scores each item from 1 to 4 for a minimum score of 20 to a maximum of 80. Low scores mean less anxiety and better outcome and a high score means greater anxiety and worse outcome. Positively phrased items are reverse-scored to calculate the total score.
次要结局
未报告次要终点
研究者
Mohammad Zeeshan Haider
Resident Doctor
Liaquat National Hospital & Medical College