Nurse-Delivered Brief Pain Relief Skills Treatment in Rural Communities

This study will be conducted as a randomized controlled trial comparing effects of Empowered Relief (ER) to a Health Education (HE) session for participants with chronic pain recruited from rural clinics when ER is provided by ER-trained nurses. Participants (N=400) will complete an online eligibility form to screen for inclusion and exclusion criteria and advance to a consent process if eligible. Eight nurses recruited from rural communities will receive ER training facilitated by Stanford Pain Relief Innovations Lab. Recruitment will occur through three partnering rural health clinics. Study participants will be asked to complete a baseline survey of demographics and health variables and then randomized to one of two study groups: ER and HE. Participants randomized to the ER group will complete a Health Insurance Portability and Accountability Act \[HIPAA\] compliant, password protected Zoom ER class delivered by an ER-trained rural nurse instructor. Participants assigned to HE will receive a standardized online self-paced intervention.

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

Primary outcomes

• Pain intensity [3 months]: Patient-reported outcomes measures (PROMIS) Pain Intensity short form 1a to measure reported average pain intensity over the previous seven days using an 11-point Likert scale (0 = no pain; 10 = worst imaginable pain). The minimum value is 0 and maximum value is 10 with higher scores meaning a worse outcome.
• Pain interference [3 months]: Patient-reported outcomes measures (PROMIS) 8-item pain interference measure to collect reported pain interference with various activities in the previous seven days on a scale of 1 to 5 (1 = not at all; 5 = very much); the minimum value is 8 and maximum value is 40 with higher scores meaning a worse outcome.

Secondary outcomes

• Pain self-efficacy [3 months]: 10-item Pain Self Efficacy Questionnaire (PSEQ) is employed to measure the confidence of participants to conduct activities (e.g., work, accomplish goals) despite experiencing persistent pain. Each item is rated on a 7-point Likert scale (0 = not at all confident; 6 = completely confident). Scores are summed with higher values indicating better pain self-efficacy with minimum value of 0 and maximum value of 60.
• Pain catastrophizing scale [3 months]: 13 item Pain Catastrophizing Scale (PCS) is employed to measure the degree to which one experiences catastrophic thinking related to pain with each item rated on a 5-point Likert scale (0 = not at all; 4 = all the time). Scores are summed with higher values indicating greater and less favorable levels of catastrophizing with minimum value of 0 and maximum value of 52.
• Calm scale [3 months]: 5-item scale to measure how confident one is in reaching a calm, relaxed state under certain conditions (such as, when in pain, when anxious). Each item is rated on a 7-point Likert scale (0 = not at all confident; 6 = completely confident) with a minimum value of 0 and maximum value of 30 with higher scores meaning a more favorable outcome of higher confidence.
• Sleep disturbance [3 months]: Patient-reported outcomes measures (PROMIS) Sleep Disturbance 6-item scale that describes sleep quality and patterns. Sleep quality is rated on a scale of 5 to 1 (5 = very poor; 1 = very good) and sleep patterns on a scale of 1 to 5 (1 = not at all; 5 = very much). The minimum value is 6 and maximum value is 30 with higher scores meaning a worse outcome.
• Depression [3 months]: Patient-reported outcomes measures (PROMIS) Depression 6-item scale measured frequency of self-reported depressive symptoms on a scale from 1 to 5 (1 = never; 5 = always). The minimum value is 6 and maximum value is 30 with higher scores meaning a worse outcome.
• Fatigue [3 months]: Patient-reported outcomes measures (PROMIS) Fatigue 6-item scale in which the frequency of fatigue symptoms are rated on a scale from 1 to 5 (1 = never; 5 = very much). The minimum value is 6 and maximum value is 30 with higher scores meaning a worse outcome.
• Anxiety [3 months]: Patient-reported outcomes measures (PROMIS) Anxiety 6-item scale in which the frequency of anxiety symptoms are rated on a scale from 1 to 5 (1 = never; 5 = always). The minimum value is 6 and maximum value is 30 with higher scores meaning a worse outcome.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* ≥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

Exclusion Criteria:

* 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

• 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. PMID 41238484

• Beth D Darnall, PhD, Principal investigator, Stanford University

NIH grants: R01NR022262