Pragmatic Randomized Controlled Trial Evaluating Efficacy of Presurgical Provider-directed Behavioral and Self-directed Mindfulness Interventions in Pediatric Patients Undergoing Major Elective Surgical Procedures on Postoperative Pain Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Functional Disability Index (FDI)
研究概览
简要总结
This will be a prospective randomized study to evaluate novel, clinically feasible, easily deliverable, pragmatic ways of preemptively modifying known CPSP and behavioral risk factors for acute to chronic pain transitions in adolescents before surgery. In addition, it will provide mechanistic insights and build a strong foundation for future large scale interventional studies that can impact outcomes positively in children undergoing surgery.
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
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 10-18 years
- •English speaking
- •Ability to provide assent/consent/parent permission
- •Scheduled to undergo elective major musculoskeletal surgeries including spine fusion (idiopathic scoliosis only), abdominal surgeries, thoracic surgery including pectus repair, and major orthopedic joint surgeries.
排除标准
- •Previous exposure to psychological interventions
- •Surgery within 1 year
- •Developmental delay
- •Chronic opioid use within 6 months prior to surgery
- •Severe systemic disease
研究组 & 干预措施
Conventional care
Control Comparator
干预措施: Conventional Care (Other)
Self-directed mindfulness
干预措施: Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation (Other)
Provider-directed mindfulness
干预措施: Provider-directed mindfulness (Other)
结局指标
主要结局
Functional Disability Index (FDI)
时间窗: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 4 months.
15-item survey that assesses the extent to which children experience difficulties in completing specific tasks (for example, walking to the bathroom, eating regular meals, and being at school all day).
次要结局
- Child Anxiety Sensitivity Index (CASI)(Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.)
- Child and Adolescent Mindfulness Measure (CAMM)(Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.)
- Electronic Pain Diary and PainDETECT(Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.)
- Perioperative Opioid use(Postoperative inpatient (if applicable), 1 week, 2 weeks and 3-4 months postoperatively.)
- Pain Coping Efficacy(Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months)
- PROMIS pain interference-short form(Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.)