- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07335159
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Adam Hanley
- Phone Number: 850-645-9557
- Email: adam.hanley@fsu.edu
Study Contact Backup
- Name: Carter Minnick
- Email: cm25bo@fsu.edu
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32308
- Recruiting
- Tallahassee Orthopedic Clinic
-
Contact:
- Emilie Miley
- Phone Number: 850-877-8174
- Email: research@teamtoc.com
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Chronic Pain
- Acute Pain
- Agnosia
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Cognitive Behavioral Therapy
- Mindfulness
Other Study ID Numbers
- STUDY00004916_Testimonial
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.
Clinical Trials on Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on Pain Psychoeducation
-
Florida State UniversityCompletedPain | Acute PainUnited States
-
Florida State UniversityRecruitingPain | Chronic Pain | Acute PainUnited States
-
University of UtahCompletedPain | Pain, Acute | Pain, JointUnited States
-
University of California, IrvineActive, not recruitingIBS - Irritable Bowel Syndrome | IBD - Inflammatory Bowel DiseaseUnited States
-
Florida State UniversityCompletedPain | Acute PainUnited States
-
Chang Gung Memorial HospitalNational Science and Technology CouncilRecruitingPain, Postoperative | Shoulder PainTaiwan
-
University of MichiganNational Institute on Drug Abuse (NIDA)Completed
-
Universidad Autonoma de Baja CaliforniaNot yet recruiting
-
University of UtahCompletedPain | Osteoarthritis, Knee | Osteoarthritis, HipUnited States
-
University of GaziantepCompletedPsychoeducation StudyTurkey (Türkiye)