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Empowered Relief Delivered by Nurses

Addressing Pain Care Inequities With Empowered Relief Delivered by ASPMN Nurses: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05934435
Acronym
ERA
Enrollment
149
Registered
2023-07-07
Start date
2023-11-01
Completion date
2024-11-13
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Chronic

Keywords

Pain

Brief 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. 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.

Interventions

psycho-educational pain skills training

Sponsors

American Society for Pain Management Nursing
CollaboratorUNKNOWN
Washington State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Biostatistician will be blinded to ER treatment group or Wait-list Control group.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain CatastrophizingParticipants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.Measured by self-report

Secondary

MeasureTime frameDescription
Change in Pain IntensityParticipants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.0-10 Pain severity scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026