ER-Y: Empowered Relief for Youth
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Empowered Relief for Youth
The Empowered Relief for Youth is a 90-minute class that provides pain science education, as well as cognitive, emotional, and physiologic self-regulation skills for youth with chronic pain. Youth will also develop a personalized plan to use the acquired skills daily. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.
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Outcome Measures
Primary Outcome Measures
- Treatment Expectancy Credibility (TEC-C) [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 [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 Outcome Measures
- PROMIS Pain Interference [Pre class, 4 weeks, 8 weeks, and 12 weeks post class]
The PROMIS Pain Interference form assesses to what level pain hinders their engagement in several activities using a ranked scale (score 0 = "never" to 4 = "almost always") with a higher score indicating great pain interference.
- Patient Global Impression of Change (PGIC) [4 weeks, 8 weeks, and 12 weeks post class]
The Pain Global Impression of Change survey asks participants to rank how their overall pain has changed since the start of study using a ranked scale (score 0 = "very much improved" to 6 = "very much worse") with higher scores indicating greater severity to their pain.
- Pain Catastrophizing Scale (PCS) [Pre class, 4 weeks, 8 weeks, and 12 weeks post class]
The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain. The PCS-C is comprised of 13-items rated on a 5-point Likert scale (score 0= "not at all true" to 4 "very true"). A total score (0-52) is obtained by summing all items. Higher scores indicate higher levels of catastrophic thinking.
Other Outcome Measures
- Child Pain Self-Efficacy Scale (PSES-C) [Pre class, 4 weeks, 8 weeks, and 12 weeks post class]
The Child Pain Self- Efficacy Scale assesses the participants self-efficacy with regard to normal functioning when in pain based on a ranked scale (score 1 = "very sure" to 5 = "very unsure") with higher scores indicating enhanced uncertainty.
- PROMIS Anxiety [Pre class, 4 weeks, 8 weeks, and 12 weeks post class]
The PROMIS anxiety study assesses fear, fear, misery, hyperarousal, and somatic symptoms related to arousal within the past seven days. Each item is scored on a 1-5 rating scale (score 1 = "never" to 5 = "almost always") with higher scores indicating greater experience to anxiety.
- PROMIS Depression [Pre class, 4 weeks, 8 weeks, and 12 weeks post class]
The PROMIS depression study assesses symptoms related to depression within the past seven days. Each item is scored on a 1-5 rating scale (score 1 = "never" to 5 = "almost always") with higher scores indicating greater depressive symptoms.
- Hope Scale [Pre class, 4 weeks, 8 weeks, and 12 weeks post class]
The Hope Scale assess the participant's hope level based on a ranked scale (score 1 = "definitely false" to 8 = "definitely true") with a higher score indicating highly hopeful.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age at least 10 years old to 18 years
-
Diagnosis of Chronic Pain
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English speaking
Exclusion Criteria:
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Diagnosis of neurological conditions such as seizures, cerebral palsy, developmental delay
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Severe affective disorder (e.g., severe depression/ anxiety) from medical record review.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Palo Alto | California | United States | 94304 |
Sponsors and Collaborators
- Stanford University
Investigators
- Principal Investigator: Laura Simons, PhD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 68451