Empowered Relief for Youth

NCT05998369 | Completed

• 1 other identifier: 68451
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Musculoskeletal Pain; Fibromyalgia; Neuropathic Pain; Complex Regional Pain Syndromes; Abdominal Pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• PROMIS Pain Interference

  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

• Pain Catastrophizing Scale (PCS)

  Pre class, 4 weeks, 8 weeks, and 12 weeks post class

Other Outcomes (2)

• Child Pain Self-Efficacy Scale (PSES-C)

  Pre class, 4 weeks, 8 weeks, and 12 weeks post class

• PROMIS Anxiety

  Pre class, 4 weeks, 8 weeks, and 12 weeks post class

Study Arms (1)

Empowered Relief for Youth

EXPERIMENTAL

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

Interventions

Empowered Relief for Youth BEHAVIORAL

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.

Empowered Relief for Youth

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age at least 10 years old to 18 years
• Diagnosis of Chronic Pain
• English speaking

You may not qualify if:

• Significant psychosocial complexity (e.g., severe depression/ anxiety, unable to tolerate a group setting)
• non-English Speaking

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain; Fibromyalgia; Neuralgia; Complex Regional Pain Syndromes; Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Signs and Symptoms, Digestive

Study Officials

• Laura Simons, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 21, 2023
• Study Start: August 9, 2023
• Primary Completion: December 20, 2024
• Study Completion: April 1, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (1)