Empowered Relief Delivered by Nurses

NCT05934435 | Completed

• 1 other identifier: 20013-001
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Catastrophizing

  Measured by self-report

  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

  Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.

Study Arms (2)

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.

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.

Other: Empowered Relief

Interventions

Empowered Relief OTHER

psycho-educational pain skills training

Also known as: ER

Empowered Relief treatment; Wait-list Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington State University: lead
• American Society for Pain Management Nursing: collaborator

Study Sites (1)

Washington State University

Spokane, Washington, 99201, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marian Wilson, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Biostatistician will be blinded to ER treatment group or Wait-list Control group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: July 7, 2023
• Study Start: November 1, 2023
• Primary Completion: October 25, 2024
• Study Completion: November 13, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication
• Access Criteria: Use for secondary analysis

Locations

US (1)