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Behavioral Intervention
Empowered Relief Class for Chronic Pain (ER-Y Trial)
N/A
Recruiting
Led By Laura Simons, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Chronic Pain
Age at least 10 years old to 18 years
Must not have
Diagnosis of neurological conditions such as seizures, cerebral palsy, developmental delay
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post class
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a single-session pain management class to help youth manage their chronic pain. Feasibility and acceptability will be assessed, and its efficacy tracked over 12 weeks.
Who is the study for?
This trial is for English-speaking youths aged 10 to 18 who have been diagnosed with various types of chronic pain, including neuropathic pain and fibromyalgia. It's not suitable for those with neurological conditions like seizures or severe mental health issues such as intense depression or anxiety.
What is being tested?
The study tests a single-session class called Empowered Relief for Youth (ER-Y), which educates about pain science and teaches self-regulation skills for managing chronic pain. The program's feasibility and effectiveness will be evaluated over a period of up to 12 weeks post-class.
What are the potential side effects?
Since ER-Y involves educational classes rather than medication, traditional side effects are not expected. However, participants may experience varying degrees of emotional discomfort when discussing their experiences with chronic pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with chronic pain.
Select...
I am between 10 and 18 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a neurological condition like seizures or cerebral palsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks, 8 weeks, and 12 weeks post class
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks, 8 weeks, and 12 weeks post class
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Program Feedback Scale
Treatment Expectancy Credibility (TEC-C)
Secondary study objectives
PROMIS Pain Interference
Pain Catastrophizing Scale (PCS)
Patient Global Impression of Change (PGIC)
Other study objectives
Child Pain Self-Efficacy Scale (PSES-C)
Hope Scale
PROMIS Anxiety
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Empowered Relief for YouthExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,474 Previous Clinical Trials
17,501,880 Total Patients Enrolled
Laura Simons, PhDPrincipal InvestigatorStanford University
3 Previous Clinical Trials
127 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with chronic pain.I am between 10 and 18 years old.I have been diagnosed with a neurological condition like seizures or cerebral palsy.You have a serious mental health condition, like severe depression or anxiety, as noted in your medical records.
Research Study Groups:
This trial has the following groups:- Group 1: Empowered Relief for Youth
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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