Does Choice Improve the Pain Relief Derived From a Brief Intervention

March 18, 2025 updated by: Adam Hanley, Florida State University

Brief (<10 Minute) Behavioral Interventions for Pain

This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience. Participants will be randomized to one of three conditions: 1) a 4-minute pain psychoeducation recording, 2) a 4-minute mindfulness recording, or 3) choice. In the choice condition, participants will be able to choose which recoding (i.e., pain psychoeducation or mindfulness) they would like to listen to.

Study Type

Interventional

Enrollment (Actual)

212

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 Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Orthopedic Clinic (TOC)

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

Yes

Description

Inclusion Criteria:

  • Receiving pain 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
Experimental: Mindful Pain Management (randomized)
In the control mindful pain management intervention, participants will be randomized to listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice.
Behavioral: Mindful Pain Management
In the mindful pain management intervention, participants will listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice.
Active Comparator: Pain Psychoeducation (randomized)
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) and accessible resources to promote overall well-being.
Behavioral: Pain Psychoeducation
In the pain psychoeducation intervention, participants will be provided a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being.
Experimental: Choice: Mindful Pain Management
In the choice mindful pain management intervention, participants will choose to listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice.
Behavioral: Mindful Pain Management
In the mindful pain management intervention, participants will listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice.
Active Comparator: Choice: Pain Psychoeducation
In the choice pain psychoeducation intervention, participants will choose to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being.
Behavioral: Pain Psychoeducation
In the pain psychoeducation intervention, participants will be provided a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being.

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 7 to 10-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 7 to 10-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 7 to 10-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 7 to 10-minute audio recording
Change in Anxiety Numeric Rating Scale
Time Frame: Immediately before to after 7 to 10-minute audio recording
Change in anxiety from baseline will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety.
Immediately before to after 7 to 10-minute audio recording

Collaborators and Investigators

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

Sponsor

Florida State University

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)

September 4, 2024

Primary Completion (Actual)

November 25, 2024

Study Completion (Actual)

November 25, 2024

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004916_MOD5065

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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