Chronic PainER-YNCT05998369
Empowered Relief for Youth
A study testing Empowered Relief for Youth in people with Chronic Pain and Musculoskeletal Pain, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain, Fibromyalgia
- What is being tested?
- Empowered Relief for Youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age at least 10 years old to 18 years
- Diagnosis of Chronic Pain
- English speaking
Who cannot join
- Significant psychosocial complexity (e.g., severe depression/ anxiety, unable to tolerate a group setting)
- non-English Speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empowered Relief for Youth: A Feasibility Study of a Pain Management Class for Youth With Pain
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.
Read the 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.
- Conditions
- Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Neuropathic Pain, Complex Regional Pain Syndromes, Abdominal Pain
- Being tested
- Empowered Relief for Youth
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Neuralgia, Complex Regional Pain Syndromes, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered Relief for YouthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Empowered Relief for Youth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Expectancy Credibility (TEC-C) - Acceptability
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.
Measured: Immediately post class
Program Feedback Scale - Acceptability
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.
Measured: Immediately post class
Enrollment - Feasibility
Percentage of enrollment following referral
Measured: prior to class
Attendance - Feasibility
Percentage who attended class after consent
Measured: immediately post class
Retention - Feasibility
Percentage who completed follow-up assessments
Measured: 1, 2, 3 month follow-up
Secondary outcomes (3)
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.
Measured: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
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.
Measured: 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.
Measured: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start9 Aug 2023
- Primary completion20 Dec 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura E Simons, Stanford University
- Investigators
- Laura Simons, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998369
- Sponsor's protocol ID
- 68451
- Acronym
- ER-Y
- Status last verified
- Jul 2026
- First submitted
- 9 Aug 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowered Relief for Youth: A Feasibility Study of a Pain Management Class for Youth With Pain
- ClinicalTrials.gov ID
- NCT05998369
- Acronym / sponsor ID
- ER-Y / 68451
- Conditions
- Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Neuropathic Pain, Complex Regional Pain Syndromes, Abdominal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Empowered Relief for Youth | Experimental | Behavioral: Empowered Relief for YouthEmpowered 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age at least 10 years old to 18 years
- Diagnosis of Chronic Pain
- English speaking
Key exclusion criteria (2 listed)
- Significant psychosocial complexity (e.g., severe depression/ anxiety, unable to tolerate a group setting)
- non-English Speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowered Relief for YouthThe 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. | Behavioural | Empowered Relief for Youth |
Primary outcome
Treatment Expectancy Credibility (TEC-C) - Acceptability
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 - Acceptability
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.
Enrollment - Feasibility
Time frame: prior to class
Percentage of enrollment following referral
Attendance - Feasibility
Time frame: immediately post class
Percentage who attended class after consent
Retention - Feasibility
Time frame: 1, 2, 3 month follow-up
Percentage who completed follow-up assessments
3 secondary outcomes
PROMIS Pain Interference
Time frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Patient Global Impression of Change (PGIC)
Time frame: 4 weeks, 8 weeks, and 12 weeks post class
Pain Catastrophizing Scale (PCS)
Time frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Simons, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Relief for Youth in people with Chronic Pain and Musculoskeletal Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Expectancy Credibility (TEC-C) - Acceptability (time frame: Immediately post class). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.