Chronic PainNCT07863375
Nurse-Delivered Brief Pain Relief Skills Treatment in Rural Communities
A study testing Pain relief skills training and Health Education in people with Chronic Pain, run by Washington State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain relief skills training and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Washington State University
Spokane, Washington, 99202
Marian L Wilson, PhD, 509-358-7972, marian.wilson@wsu.edu
Ross J Bindler, PharmD, 509-358-7987, rossb4@wsu.edu
About this study
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Chronic Pain
- Being tested
- Pain relief skills training, Health Education
- 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.
Pain relief skills trainingBehavioural
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 EducationOther
A digital health education intervention is roughly matched for time, attention, and daily text for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Empowered Relief | Experimental | Participants randomized to the ER group will complete a HIPAA compliant, password protected 2-hour Zoom ER class delivered by an ER-trained registered nurse (RN). Receives: Behavioral: Pain relief skills training |
| Health Education | Active comparator | Participants randomized to the digital Health Education (HE) Control group will receive an educational intervention similar in time and attention to compare with the experimental treatment group. Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
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.
Measured: 3 months
Pain interference
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.
Measured: 3 months
Secondary outcomes (7)
Pain self-efficacy
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.
Measured: 3 months
Pain catastrophizing scale
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.
Measured: 3 months
Calm scale
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.
Measured: 3 months
Sleep disturbance
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.
Measured: 3 months
Depression
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.
Measured: 3 months
Fatigue
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.
Measured: 3 months
Anxiety
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Mar 2027 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Marian Wilson, Washington State University
- Investigators
- Beth D Darnall, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863375
- Sponsor's protocol ID
- 26-0727
- Other IDs
- R01NR022262
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All outcomes data will be available to share pending appropriate data use agreements.
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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Delivered Brief Pain Relief Skills Treatment in Rural Communities
- ClinicalTrials.gov ID
- NCT07863375
- Acronym / sponsor ID
- 26-0727
- Conditions
- Chronic Pain
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empowered Relief | Experimental | Behavioral: Pain relief skills trainingParticipants randomized to the ER group will complete a HIPAA compliant, password protected 2-hour Zoom ER class delivered by an ER-trained registered nurse (RN). |
| Health Education | Active comparator | Other: Health EducationParticipants randomized to the digital Health Education (HE) Control group will receive an educational intervention similar in time and attention to compare with the experimental treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Pain relief skills trainingRural 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.. | Behavioural | Empowered Relief |
| Health EducationA digital health education intervention is roughly matched for time, attention, and daily text for 90 days. | Other | Health Education |
Primary outcome
Pain intensity
Time frame: 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
Time frame: 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.
7 secondary outcomes
Pain self-efficacy
Time frame: 3 months
Pain catastrophizing scale
Time frame: 3 months
Calm scale
Time frame: 3 months
Sleep disturbance
Time frame: 3 months
Depression
Time frame: 3 months
Fatigue
Time frame: 3 months
Anxiety
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: 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.
- NIH Reporter information on this studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All outcomes data will be available to share pending appropriate data use agreements.
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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.
Beth D Darnall, PhD principal investigator
Stanford 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 Pain relief skills training and Health Education in people with Chronic Pain, 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 15 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marian L Wilson, PhD (509-358-7972, marian.wilson@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT07863375, 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 15 Oct 2026.