Empowered Relief for Youth

Chronic Pain Clinical Trial

— ER-Y  

Official title:

Empowered Relief for Youth: A Feasibility Study of a Pain Management Class for Youth With Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05998369
• Other study ID #: 68451
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: November 2025

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: Dylan Mayanja, BA
• Phone: 650-736-2945
• Email: dmayanja[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age at least 10 years old to 18 years

• Diagnosis of Chronic Pain

• English speaking

Exclusion Criteria:

• Diagnosis of neurological conditions such as seizures, cerebral palsy, developmental delay

• Severe affective disorder (e.g., severe depression/ anxiety) from medical record review.

Related Conditions & MeSH terms

• Abdominal Pain
• Chronic Pain
• Complex Regional Pain Syndromes
• Fibromyalgia
• Musculoskeletal Pain
• Neuralgia
• Neuropathic Pain
• Reflex Sympathetic Dystrophy

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child Pain Self-Efficacy Scale (PSES-C)	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.	Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Other	PROMIS Anxiety	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.	Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Other	PROMIS Depression	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.	Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Other	Hope Scale	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.	Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Primary	Treatment Expectancy Credibility (TEC-C)	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.	Immediately post class
Primary	Program Feedback Scale	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.	Immediately post class
Secondary	PROMIS Pain Interference	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.	Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Secondary	Patient Global Impression of Change (PGIC)	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.	4 weeks, 8 weeks, and 12 weeks post class
Secondary	Pain Catastrophizing Scale (PCS)	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.	Pre class, 4 weeks, 8 weeks, and 12 weeks post class