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Nurse-Delivered Brief Pain Relief Skills Treatment in Rural Communities

ConditionChronic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington State University

About this trial

The goal of this randomized clinical trial is to learn if a nurse-delivered psychoeducational pain management skills intervention \[Empowered Relief\] can improve pain outcomes for adults with chronic pain who live in rural communities The main question\[s\] it aims to answer are:

Does nurse-delivered Empowered Relief improve pain intensity and pain interference more than a health education intervention after 3 months? Does nurse-delivered Empowered Relief improve pain catastrophizing, pain self-efficacy, and relaxation response more than a health education intervention after 3 months? Does nurse-delivered Empowered Relief improve sleep disturbance, depression, fatigue, and anxiety more than a health education intervention after 3 months?

Participants will:

Attend either a single-session 2-hour Empowered Relief class or a Health Education intervention.

Complete assessments measuring pain and related symptoms with online surveys immediately post-intervention and 3 months later.

Receive daily prompts to practice skills from the intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age; Pain condition with duration ≥ 3 months; Capacity to give informed consent; Able to read, speak, and understand English; Past month average pain intensity score ≥ 4/10 on a 0-10 Numerical Rating Scale

Disqualifiers

Cognition found to be moderately or severely impaired on screening; Active suicidality (online screening); Receipt of Empowered Relief or digital Health Education in the past 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pain relief skills training

    Behavioral

    Rural RN-delivered psychoeducational pain relief skills group intervention includes development of a personalized plan, downloading a corresponding app for daily and unlimited use, and daily text messages for 90 days..

  • Health Education

    Other intervention

    A digital health education intervention is roughly matched for time, attention, and daily text for 90 days.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Empowered ReliefExperimental treatment 1 intervention
Group B: Health EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity

Numeric rating 0-10 scale for pain severity

Time frame
3 months
2

Pain interference

Patient-reported outcomes measures (PROMIS) 8-item pain interference measure

Time frame
3 months

Secondary outcomes

1

Pain self-efficacy

10-item Pain Self Efficacy Questionnaire

Time frame
3 months
2

Pain catastrophizing

13 item Pain Catastrophizing Scale

Time frame
3 months
3

Relaxation response efficacy

5-item scale to measure efficacy of relaxation response

Time frame
3 months
4

Sleep disturbance

PROMIS Sleep Disturbance 6-item scale

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington State University

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: