Prevention of Postsurgical Chronic Pain in Children and Adolescents (PREVENDOL)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 125
- 试验地点
- 6
- 主要终点
- Pain intensity (pre and postsurgical)
研究概览
简要总结
Chronic postsurgical pain is a health problem with a great societal impact: approximately 20% of all children and adolescents undergoing surgery will develop chronic pain. Importantly, the risk and protective factors that are known (e.g., anxiety, catastrophizing, pain beliefs and pain coping) are modifiable, thus there is a huge potential for the development of both preventive and protective programs to avoid the transition from acute to chronic pain or reduce the impact in the lives of patients when it has already developed.
详细描述
The main objective of this project is to develop and test a program to prevent the development of chronic postsurgical pain in children and adolescents undergoing surgery in order to improve their quality of life (and that of their families). That program will be implemented in a mobile application.
This proposal will be implemented in 3 phases:
- Development of the preventive program of chronic postsurgical pain and its implementation in a mobile application
- Usability test of the mobile application
- Clinical trial to test the effectiveness of the preventive program
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having to undergo surgery
- •Being between 8 and 18 years old;
- •Having signed the informed consent
- •Having an ASA risk between I and III
排除标准
- •Not being able to understand Spanish
- •Having a physical and/or cognitive impairment that interferes with understanding the instructions and handling of the application (e.g., moderate to severe intellectual disability, blindness)
- •Participating in another clinical trial
- •Undergoing an urgent surgical intervention
- •Being hospitalized in intensive care due to the need for ventilation or hemodynamic support or other complications
- •Having an ASA risk of IV
- •Not having signed the informed consent
结局指标
主要结局
Pain intensity (pre and postsurgical)
时间窗: Baseline (pre); daily for 15 days post-surgery; at 3 and 6 months follow-up
Pain intensity will be recorded using the 0-10 Numerical Rating Scale, with higher scores indicating greater pain intensity
Pain interference (pre and postsurgical)
时间窗: Baseline (pre), and at 3 and 6 months after surgery (post)
Pain intensity will be recorded using the 8-item PROMIS Pediatric Pain Interference Scale, with higher scores indicating greater pain interference. PROMIS measures are scored as T-scores, with a mean of 50 points and an SD of 10.
次要结局
- Change in quality of life(Baseline (pre) and 3 and 6 months follow-up)
- Change in functional disability(Baseline (pre) and 3 and 6 months follow-up)
- Change in anxiety and depressive symptoms(Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up)
- Change in pain beliefs(Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up)
- Change in pain catastrophizing(Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up)
- Change in pain coping(Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up)
- Change in sleep quality(Baseline (pre); before surgery and after the CBT (pre), daily for 15 days post-surgery; at 3 and 6 months follow-up)
研究者
Elisabet Sánchez-Rodríguez
Principal Investigator
University Rovira i Virgili