Does Patient Testimonial Improve the Pain Relief Derived From a Brief Intervention

March 27, 2026 updated by: Adam Hanley, Florida State University

Does Patient Testimonial Improve the Pain Relief Derived From a Brief Behavioral Intervention Delivered to Patients Experiencing Pain in a Clinic Waiting Room

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Florida
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Tallahassee Orthopedic Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Receiving treatment at Tallahassee Orthopedic Center
  • Understanding English instructions fluently
  • Being 18 years of age or older

Exclusion Criteria:

  • Unable to consent because of physical or mental incapacity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pain Psychoeducation
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 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.
Experimental: Mindfulness
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Unpleasantness Numeric Rating Scale
Time Frame: Immediately before to after 4-minute audio recording
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity Numeric Rating Scale
Time Frame: Immediately before to after 4-minute audio recording
Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity.
Immediately before to after 4-minute audio recording

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interest in additional pain management resources
Time Frame: Immediately after the 4-minute audio recording
After the recording, participants will complete a single dichotomous (yes/no) item assessing interest in additional pain management resources: "Would you like access to additional pain management resources similar to the one presented today?"
Immediately after the 4-minute audio recording
Net Promoter Scale
Time Frame: Immediately after the 4-minute audio recording
The Net Promoter Scale (NPS) is a single-item measure of satisfaction and loyalty that asks respondents to rate how likely they are to recommend a product, service, or experience to others, typically on an 11-point scale from 0 ("not at all likely") to 10 ("extremely likely"). Responses are categorized as detractors (0-6), passives (7-8), or promoters (9-10). The overall NPS score is calculated by subtracting the percentage of detractors from the percentage of promoters, yielding a score ranging from -100 to +100.
Immediately after the 4-minute audio recording

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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