Abdominal Pain, Chronic Pain, Complex Regional Pain Syndromes, Fibromyalgia, Musculoskeletal Pain, Neuropathic Pain
Conditions
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.
Interventions
BEHAVIORALEmpowered 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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Expectancy Credibility (TEC-C) - Acceptability | 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. |
| Program Feedback Scale - Acceptability | 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. |
| Enrollment - Feasibility | prior to class | Percentage of enrollment following referral |
| Attendance - Feasibility | immediately post class | Percentage who attended class after consent |
| Retention - Feasibility | 1, 2, 3 month follow-up | Percentage who completed follow-up assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Interference | 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. |
| Patient Global Impression of Change (PGIC) | 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. |
| Pain Catastrophizing Scale (PCS) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaura Simons, PhD
Stanford University
Outcome results
None listed