Does Patient Testimonial Improve the Pain Relief Derived From a Brief Intervention
1 other identifier
interventional
400
1 country
1
Brief Summary
This project is a single-site, two-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room an audio-recorded mindfulness practice decreases their pain relative to an injury management control condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Jan 2026
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2026
CompletedStudy Start
First participant enrolled
January 5, 2026
CompletedFirst Posted
Study publicly available on registry
January 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
March 30, 2026
March 1, 2026
5 months
January 5, 2026
March 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Pain Unpleasantness Numeric Rating Scale
Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.
Immediately before to after 4-minute audio recording
Secondary Outcomes (1)
Change in Pain Intensity Numeric Rating Scale
Immediately before to after 4-minute audio recording
Other Outcomes (2)
Interest in additional pain management resources
Immediately after the 4-minute audio recording
Net Promoter Scale
Immediately after the 4-minute audio recording
Study Arms (2)
Pain Psychoeducation
ACTIVE COMPARATORIn the pain psychoeducation intervention, participants will be randomized to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.
Mindfulness
EXPERIMENTALIn the mindfulness intervention, participants will be randomized to listen to 1 minute of psychoeducation about mindfulness that includes a patient testimonial, 1 minute of mindful breathing, 1 minute of mindful mapping (i.e., mindfulness of pain), and 1 minute of mindfulness of personal meaning.
Interventions
In the pain psychoeducation intervention, participants will be randomized to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.
In the mindfulness intervention, participants will be randomized to listen to 1 minute of psychoeducation about mindfulness that includes a patient testimonial, 1 minute of mindful breathing, 1 minute of mindful mapping (i.e., mindfulness of pain), and 1 minute of mindfulness of personal meaning.
Eligibility Criteria
You may qualify if:
- Receiving treatment at Tallahassee Orthopedic Center
- Understanding English instructions fluently
- Being 18 years of age or older
You may not qualify if:
- Unable to consent because of physical or mental incapacity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tallahassee Orthopedic Clinic
Tallahassee, Florida, 32308, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 5, 2026
First Posted
January 13, 2026
Study Start
January 5, 2026
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
May 30, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share