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Empowered Relief for Youth (ER-Y)

Primary Purpose

Chronic Pain, Musculoskeletal Pain, Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empowered Relief for Youth
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Empowered Relief for Youth

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 9, 2023
Last Updated
August 24, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05998369
Brief Title
Empowered Relief for Youth
Acronym
ER-Y
Official Title
Empowered Relief for Youth: A Feasibility Study of a Pain Management Class for Youth With Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Neuropathic Pain, Complex Regional Pain Syndromes, Abdominal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empowered Relief for Youth
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Empowered Relief for Youth
Intervention Description
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 Outcome Measure Information:
Title
Treatment Expectancy Credibility (TEC-C)
Description
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.
Time Frame
Immediately post class
Title
Program Feedback Scale
Description
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.
Time Frame
Immediately post class
Secondary Outcome Measure Information:
Title
PROMIS Pain Interference
Description
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.
Time Frame
Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Title
Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
4 weeks, 8 weeks, and 12 weeks post class
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Other Pre-specified Outcome Measures:
Title
Child Pain Self-Efficacy Scale (PSES-C)
Description
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.
Time Frame
Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Title
PROMIS Anxiety
Description
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.
Time Frame
Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Title
PROMIS Depression
Description
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.
Time Frame
Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Title
Hope Scale
Description
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.
Time Frame
Pre class, 4 weeks, 8 weeks, and 12 weeks post class

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dylan Mayanja, BA
Phone
650-736-2945
Email
dmayanja@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy Giberson, MAS
Email
jgiberso@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Simons, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Simons, PhD
First Name & Middle Initial & Last Name & Degree
Lauren Harrison, PhD
First Name & Middle Initial & Last Name & Degree
Rashmi Bhandari, PhD

12. IPD Sharing Statement

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Empowered Relief for Youth

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