Empowered Relief for Youth: A Feasibility Study of a Pain Management Class for Youth With Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Treatment Expectancy Credibility (TEC-C)
研究概览
简要总结
The purpose of this pilot study is to examine the feasibility and preliminary efficacy of Empowered Relief for Youth with chronic pain (ER-Y). ER-Y is a single-session pain management class for youth focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class. Feasibility and acceptability of ER-Y will be assessed post-class. Preliminary efficacy will be assessed by administering surveys at baseline, 4-weeks, 8-weeks, and 12-weeks post class.
详细描述
The current proposed, single-arm, uncontrolled pilot study will determine a) feasibility of ER-Y in youth with chronic pain, b) patients' perceptions and satisfaction of the ER-Y class and c) preliminary efficacy to inform the design of a subsequent randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age at least 10 years old to 18 years
- •Diagnosis of Chronic Pain
- •English speaking
排除标准
- •Significant psychosocial complexity (e.g., severe depression/ anxiety, unable to tolerate a group setting)
- •non-English Speaking
研究组 & 干预措施
Empowered Relief for Youth
Empowered Relief for Youth is a single-session pain management class focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class.
干预措施: Empowered Relief for Youth (Behavioral)
结局指标
主要结局
Treatment Expectancy Credibility (TEC-C)
时间窗: Immediately post class
The TEC-C assess treatment expectations and credibility with standardized sum scores from using a numeric rating scale (score 0 = "not at all" to 10 = "very much") with a higher score indicating high expectations.
Program Feedback Scale
时间窗: Immediately post class
The Program Feedback Scale assesses participants agreement to seven statements indicating their perceived acceptability and feasibility based on a scale (score 0 = "really disagree" to 4 = "really agree") with a higher score indicating positive feedback and two open ended questions.
Enrollment - Feasibility
时间窗: prior to class
Percentage of enrollment following referral
Attendance - Feasibility
时间窗: immediately post class
Percentage who attended class after consent
Retention - Feasibility
时间窗: 1, 2, 3 month follow-up
Percentage who completed follow-up assessments
Treatment Expectancy Credibility (TEC-C) - Acceptability
时间窗: Immediately post class
The TEC-C assess treatment expectations and credibility with standardized sum scores from using a numeric rating scale (score 0 = "not at all" to 10 = "very much") with a higher score indicating high expectations.
Program Feedback Scale - Acceptability
时间窗: Immediately post class
The Program Feedback Scale assesses participants agreement to seven statements indicating their perceived acceptability and feasibility based on a scale (score 0 = "really disagree" to 4 = "really agree") with a higher score indicating positive feedback and two open ended questions.
次要结局
- Pain Catastrophizing Scale (PCS)(Pre class, 4 weeks, 8 weeks, and 12 weeks post class)
- Patient Global Impression of Change (PGIC)(4 weeks, 8 weeks, and 12 weeks post class)
- PROMIS Pain Interference(Pre class, 4 weeks, 8 weeks, and 12 weeks post class)
研究者
Laura E Simons
Professor
Stanford University