Empowered Relief for Youth: A Feasibility Study of a Pain Management Class for Youth With Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Stanford University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Treatment Expectancy Credibility (TEC-C)
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Laura E Simons
Professor
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Age at least 10 years old to 18 years
- •Diagnosis of Chronic Pain
- •English speaking
Exclusion Criteria
- •Significant psychosocial complexity (e.g., severe depression/ anxiety, unable to tolerate a group setting)
- •non-English Speaking
Outcomes
Primary Outcomes
Treatment Expectancy Credibility (TEC-C)
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)