Pain, ChronicERANCT05934435
Empowered Relief Delivered by Nurses
A study testing Empowered Relief in people with Pain, Chronic, run by Washington State University at 1 site in United States.
Trial summary
This study will investigate effects of a psychoeducation pain management skills intervention on adults with persistent pain by training a cohort of American Society for Pain Management Nursing (ASPMN) nurses to deliver and it [Empowered Relief (ER)], as a single-session video-conferenced program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Empowered Relief
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 13 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- pain >3 months more than half the time
- English fluency
- ability to attend a one-time web-based class and complete web-based surveys.
Who cannot join
- Previous participation in ER class
- cognitive impairment
- non-English speaking
- psychological factors that would preclude comprehension of material or full participation in the study as determined by the investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University
Spokane, Washington, 99201
About this study
Official title: Addressing Pain Care Inequities With Empowered Relief Delivered by ASPMN Nurses: A Randomized Controlled Trial
This study will investigate effects of a psychoeducation pain management skills intervention on adults with persistent pain by training a cohort of American Society for Pain Management Nursing (ASPMN) nurses to deliver and it [Empowered Relief (ER)], as a single-session video-conferenced program. The primary objective is to evaluate the effects of ASPMN nurse-provided ER versus waitlist control (WLC) on pain catastrophizing, pain bothersomeness, pain intensity, pain interference, sleep disturbance, physical function, depression, anxiety, and social isolation for patients with persistent pain. Secondarily, feasibility and acceptability of the ER program will be assessed through recruitment and retention data and qualitative satisfaction data.
Read the detailed description
Design: This study will be conducted as a randomized controlled trial comparing effects of ER to a WLC of participants with persistent pain when ER is provided by ER-trained ASPMN nurses. The secondary aims of feasibility and acceptability will use qualitative descriptive methods.
Participants: Participants (N=170) will be adults aged 18 and above years with self- reported or clinically diagnosed persistent pain. Participants will be recruited at clinical sites identified by ER-trained nurses and can be self or clinician referred. Participants will complete an online eligibility form to screen for inclusion and exclusion criteria. Inclusion criteria: pain >3 months more than half the time, English fluency, ability to attend a one-time web-based class and complete web-based surveys, age > 18 years. Exclusion criteria: Previous participation in ER class, cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material or full participation in the study as determined by the investigators.
Procedures: Twenty ASPMN nurses will receive ER training facilitated by Stanford Pain Relief Innovations Lab. ER- trained nurse providers will be ASPMN-member nurses of any clinical background. ASPMN nurses will be invited to apply to become a trainer with the following expectations: ability to fully participate in a live, online, 2-day ER instructor training, able to fluently complete instructor training and deliver the ER program in English, commitment to deliver 1-3 live, online, 2-hour ER programs for patient participants, and willingness to complete post-program surveys after each session they deliver reporting on number of participants and any barriers encountered. Recruitment will occur through ASPMN-related mechanisms of communication, including its website, national officers and directors, newsletter, research group, national committees, chapter leadership and listserv.
After meeting eligibility criteria and completing informed consent, study participants will be asked to complete a baseline survey of demographics and health variables (as outlined in Table 1) and then randomized 1:1 to one of two unblinded study groups: ER and WLC. Participants randomized to the ER group will complete a HIPAA compliant, password protected Zoom ER class delivered by an ER-trained ASPMN nurse. A crossover intervention class will be offered to those patient participants randomized to WLC once the ER group has completed their class and follow up assessments, estimated at 2 months post intervention.
- Conditions
- Pain, Chronic
- Being tested
- Empowered Relief
- Keywords
- Pain
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered ReliefOther
Also called ER
psycho-educational pain skills training
| Study group | Role | What they receive |
|---|---|---|
| Empowered Relief treatment | Experimental | Participants randomized to the ER group will complete a HIPAA compliant, password protected 2-hour Zoom ER class delivered by an ER-trained ASPMN nurse. Receives: Other: Empowered Relief |
| Wait-list Control | Other | Participants randomized to the Wait-list Control group will continue their usual pain care for 2 months and complete surveys to compare with the experimental treatment group. After serving as controls, they will be invited to attend the 2-hour Zoom ER class delivered by an ER-trained ASPMN nurse. Receives: Other: Empowered Relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Catastrophizing
Measured by self-report on Pain Catastrophizing Scale, a 13-item scale that uses a 5-point Likert scale (0 = not at all; 4 = all the time) to measure how often negative thoughts and feelings occur when experiencing pain. It is scored by summing all items for a total PCS score (range 0-52), with higher scores indicating more frequent pain-related catastrophic thoughts.
Measured: Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.
Secondary outcomes (1)
Change in Pain Intensity
0-10 Pain severity scale using PROMIS Pain Intensity short form 1a where average pain intensity over the previous seven days is self-reported using an 11-point Likert scale (0 = no pain; 10 = worst imaginable pain) where higher scores are worse outcomes.
Measured: Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Nov 2023
- Primary completion25 Oct 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- After randomized 1:1 to one of two unblinded study groups: ER and Wait-List Control, participants randomized to the ER group will complete the ER class. A crossover intervention class will be offered to those patient participants randomized to WLC once the ER group has completed their class and follow up assessments, estimated at 2 months post intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Pain Management Nursing
- Responsible party
- Principal investigator, Marian Wilson, Washington State University
- Investigators
- Marian Wilson, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934435
- Sponsor's protocol ID
- 20013-001
- Acronym
- ERA
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2023
- Last updated
- 5 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Can be requested from principal investigator
Publications
Watson H, Perez L, Bindler RJ, Filoramo M, Saunders G, Coriasco M, Hong J, Darnall BD, Wilson M. A National Randomized Controlled Trial Evaluating ASPMN Nurse-Delivered Empowered Relief(R). Pain Manag Nurs. 2026 Feb;27(1):50-60. doi: 10.1016/j.pmn.2025.10.009. Epub 2025 Nov 13.
PubMed 41238484
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Pain Care Inequities With Empowered Relief Delivered by ASPMN Nurses: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05934435
- Acronym / sponsor ID
- ERA / 20013-001
- Conditions
- Pain, Chronic
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- American Society for Pain Management Nursing
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Posted 5 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate effects of a psychoeducation pain management skills intervention on adults with persistent pain by training a cohort of American Society for Pain Management Nursing (ASPMN) nurses to deliver and it [Empowered Relief (ER)], as a single-session video-conferenced program. The primary objective is to evaluate the effects of ASPMN nurse-provided ER versus waitlist control (WLC) on pain catastrophizing, pain bothersomeness, pain intensity, pain interference, sleep disturbance, physical function, depression, anxiety, and social isolation for patients with persistent pain. Secondarily, feasibility and acceptability of the ER program will be assessed through recruitment and retention data and qualitative satisfaction data.
Detailed description
Design: This study will be conducted as a randomized controlled trial comparing effects of ER to a WLC of participants with persistent pain when ER is provided by ER-trained ASPMN nurses. The secondary aims of feasibility and acceptability will use qualitative descriptive methods.
Participants: Participants (N=170) will be adults aged 18 and above years with self- reported or clinically diagnosed persistent pain. Participants will be recruited at clinical sites identified by ER-trained nurses and can be self or clinician referred. Participants will complete an online eligibility form to screen for inclusion and exclusion criteria. Inclusion criteria: pain >3 months more than half the time, English fluency, ability to attend a one-time web-based class and complete web-based surveys, age > 18 years. Exclusion criteria: Previous participation in ER class, cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material or full participation in the study as determined by the investigators.
Procedures: Twenty ASPMN nurses will receive ER training facilitated by Stanford Pain Relief Innovations Lab. ER- trained nurse providers will be ASPMN-member nurses of any clinical background. ASPMN nurses will be invited to apply to become a trainer with the following expectations: ability to fully participate in a live, online, 2-day ER instructor training, able to fluently complete instructor training and deliver the ER program in English, commitment to deliver 1-3 live, online, 2-hour ER programs for patient participants, and willingness to complete post-program surveys after each session they deliver reporting on number of participants and any barriers encountered. Recruitment will occur through ASPMN-related mechanisms of communication, including its website, national officers and directors, newsletter, research group, national committees, chapter leadership and listserv.
After meeting eligibility criteria and completing informed consent, study participants will be asked to complete a baseline survey of demographics and health variables (as outlined in Table 1) and then randomized 1:1 to one of two unblinded study groups: ER and WLC. Participants randomized to the ER group will complete a HIPAA compliant, password protected Zoom ER class delivered by an ER-trained ASPMN nurse. A crossover intervention class will be offered to those patient participants randomized to WLC once the ER group has completed their class and follow up assessments, estimated at 2 months post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- After randomized 1:1 to one of two unblinded study groups: ER and Wait-List Control, participants randomized to the ER group will complete the ER class. A crossover intervention class will be offered to those patient participants randomized to WLC once the ER group has completed their class and follow up assessments, estimated at 2 months post intervention.
| Arm | Type | Receives |
|---|---|---|
| Empowered Relief treatment | Experimental | Other: Empowered ReliefParticipants randomized to the ER group will complete a HIPAA compliant, password protected 2-hour Zoom ER class delivered by an ER-trained ASPMN nurse. |
| Wait-list Control | Other | Other: Empowered ReliefParticipants randomized to the Wait-list Control group will continue their usual pain care for 2 months and complete surveys to compare with the experimental treatment group. After serving as controls, they will be invited to attend the 2-hour Zoom ER class delivered by an ER-trained ASPMN nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years
- pain >3 months more than half the time
- English fluency
- ability to attend a one-time web-based class and complete web-based surveys.
Key exclusion criteria (4 listed)
- Previous participation in ER class
- cognitive impairment
- non-English speaking
- psychological factors that would preclude comprehension of material or full participation in the study as determined by the investigators.
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 ReliefAlso: ERpsycho-educational pain skills training | Other | Empowered Relief treatment, Wait-list Control |
Primary outcome
Pain Catastrophizing
Time frame: Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.
Measured by self-report on Pain Catastrophizing Scale, a 13-item scale that uses a 5-point Likert scale (0 = not at all; 4 = all the time) to measure how often negative thoughts and feelings occur when experiencing pain. It is scored by summing all items for a total PCS score (range 0-52), with higher scores indicating more frequent pain-related catastrophic thoughts.
1 secondary outcome
Change in Pain Intensity
Time frame: Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41238484Watson H, Perez L, Bindler RJ, Filoramo M, Saunders G, Coriasco M, Hong J, Darnall BD, Wilson M. A National Randomized Controlled Trial Evaluating ASPMN Nurse-Delivered Empowered Relief(R). Pain Manag Nurs. 2026 Feb;27(1):50-60. doi: 10.1016/j.pmn.2025.10.009. Epub 2025 Nov 13.
- Main study publication with protocol descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Can be requested from principal investigator
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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.
Marian Wilson, PhD principal investigator
Washington State 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 in people with Pain, Chronic, run by Washington State 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 4 inclusion and 4 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 5 Oct 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?
Yes. Results are posted in the registry (first posted 5 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Catastrophizing (time frame: Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05934435, which also lists 1 linked publication.
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 5 Oct 2026.