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Completed

NCT Number: NCT05998369

Empowered Relief for Youth

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.

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Key information

Conditions

Chronic Pain Abdominal Pain Autonomic Nervous System Diseases Complex Regional Pain Syndromes Fibromyalgia Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rheumatic Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Treatment Expectancy Credibility (TEC-C) - Acceptability

    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.

  2. Program Feedback Scale - Acceptability

    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.

  3. Enrollment - Feasibility

    Time frame: prior to class

    Percentage of enrollment following referral

  4. Attendance - Feasibility

    Time frame: immediately post class

    Percentage who attended class after consent

  5. Retention - Feasibility

    Time frame: 1, 2, 3 month follow-up

    Percentage who completed follow-up assessments

Secondary outcomes

  1. PROMIS Pain Interference

    Time frame: 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.

  2. Patient Global Impression of Change (PGIC)

    Time frame: 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.

  3. Pain Catastrophizing Scale (PCS)

    Time frame: 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 outcomes

  1. Child Pain Self-Efficacy Scale (PSES-C)

    Time frame: 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.

  2. PROMIS Anxiety

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: ER-Y

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 21, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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