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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre class, 4 weeks, 8 weeks, and 12 weeks post class |
| Measure | Description | Time Frame |
|---|---|---|
| Child Pain Self-Efficacy Scale (PSES-C) | 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. | Pre class, 4 weeks, 8 weeks, and 12 weeks post class |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Simons, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D059352 | Musculoskeletal Pain |
| D005356 | Fibromyalgia |
| D009437 | Neuralgia |
| D020918 | Complex Regional Pain Syndromes |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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. |
| 4 weeks, 8 weeks, and 12 weeks post class |
| 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. | Pre class, 4 weeks, 8 weeks, and 12 weeks post class |
| PROMIS Anxiety |
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. |
| Pre class, 4 weeks, 8 weeks, and 12 weeks post class |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D001342 | Autonomic Nervous System Diseases |
| D012817 | Signs and Symptoms, Digestive |