Empowered Relief for Youth (ER-Y)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05998369 |
Recruitment Status :
Recruiting
First Posted : August 21, 2023
Last Update Posted : August 25, 2023
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Condition or disease | Intervention/treatment | Phase |
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Chronic Pain Musculoskeletal Pain Fibromyalgia Neuropathic Pain Complex Regional Pain Syndromes Abdominal Pain | Behavioral: Empowered Relief for Youth | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Empowered Relief for Youth: A Feasibility Study of a Pain Management Class for Youth With Pain |
Actual Study Start Date : | August 9, 2023 |
Estimated Primary Completion Date : | August 2025 |
Estimated Study Completion Date : | November 2025 |
Arm | Intervention/treatment |
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Experimental: Empowered Relief for Youth
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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Behavioral: Empowered 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. |
- Treatment Expectancy Credibility (TEC-C) [ 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.
- Program Feedback Scale [ 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- PROMIS Depression [ Time Frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class ]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.
- Hope Scale [ Time Frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05998369
Contact: Dylan Mayanja, BA | 650-736-2945 | dmayanja@stanford.edu | |
Contact: Jeremy Giberson, MAS | jgiberso@stanford.edu |
United States, California | |
Stanford University | Recruiting |
Palo Alto, California, United States, 94304 | |
Principal Investigator: Laura Simons, PhD | |
Sub-Investigator: Lauren Harrison, PhD | |
Sub-Investigator: Rashmi Bhandari, PhD |
Principal Investigator: | Laura Simons, PhD | Stanford University |
Responsible Party: | Laura E Simons, Professor, Stanford University |
ClinicalTrials.gov Identifier: | NCT05998369 |
Other Study ID Numbers: |
68451 |
First Posted: | August 21, 2023 Key Record Dates |
Last Update Posted: | August 25, 2023 |
Last Verified: | August 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Fibromyalgia Musculoskeletal Pain Neuralgia Complex Regional Pain Syndromes Reflex Sympathetic Dystrophy Chronic Pain Abdominal Pain Pain Neurologic Manifestations |
Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Peripheral Nervous System Diseases Signs and Symptoms, Digestive Autonomic Nervous System Diseases |