Use of Incentives for Children Undergoing Stressful Medical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 6
- 主要终点
- Visual Scale Self-Report Anxiety
研究概览
简要总结
The goal of this clinical trial is to learn about the use of incentives in pediatric patients requiring medical procedures. The main questions it aims to answer are: Are incentives effective at reducing pediatric anxiety for medical procedures? What is the best way to use incentives with pediatric populations requiring medical procedures? Participants will be provided support in preparation for their procedure and during the procedure by a child life specialist and might receive an incentive prize after their procedure. Participants distress levels during the procedure will be observed and they will be asked to rate their anxiety on a visual analog scale.
Researchers will compare the anxiety of those who did or did not receive an incentive after their procedure to see if incentives reduced procedural anxiety.
详细描述
The purpose of this study is to evaluate the impact incentives have on the distress and cooperation of children undergoing stressful medical procedures. The primary aim is to determine if offering an incentive reduces procedural distress for children undergoing stressful medical procedures. Secondly, if an incentive is offered does the process for offering the incentive (conditional or unconditional) to the patient impact the procedural distress of the patient. Patient anxiety and visit satisfaction will be looked at as secondary measures.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients and parent of patients aged 6-100 years who are undergoing a medical procedure
- •Patients and parent of patients who are prepared and supported by a certified child life specialist.
排除标准
- •Cognitive impairment that negates the use of the outcome tools
- •Children younger than 6 years old, or older than 17 years old.
研究组 & 干预措施
Child life standard of care
Child life standard of care
干预措施: Child life standard of care (Behavioral)
Child life standard of care + incentives provided with conditional agreement.
Child life standard of care + incentives provided with conditional agreement.
干预措施: Child life standard of care + incentives provided with conditional agreement. (Behavioral)
Child life standard of care + incentive provided unconditionally.
Child life standard of care + incentive provided unconditionally.
干预措施: Child life standard of care + incentive provided unconditionally. (Behavioral)
结局指标
主要结局
Visual Scale Self-Report Anxiety
时间窗: Immediately after the intervention/procedure/surgery
Visual analog scale used for participants to report their perceived anxiety. Scores range from 0-100, lower scores meaning the participant is less anxious.
modified Yale Preoperative Anxiety Scale (mYPAS)
时间窗: Immediately after the intervention/procedure/surgery
Observational measure of anxiety in pediatric patients. Scores range from 23.33 to 100, lower scores meaning less anxiety.
次要结局
- Visit Satisfaction Survey(Immediately after the intervention/procedure/surgery)
研究者
Jennifer Staab, MS, CCLS
Principal Investigator
Children's Hospital Colorado