Brief Mindfulness Intervention for Orthopedic Patients

June 16, 2025 updated by: Adam Hanley, Florida State University

Brief Mindfulness Intervention for a Heterogenous Mix of Orthopedic Patients

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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:

  • Age ≥18
  • Seeking foot or ankle treatment at the Tallahassee Orthopedic Center

Exclusion Criteria:

  • • Cognitive impairment preventing completion of study procedures.

    • Current cancer diagnosis,
    • Other unstable illness judged by medical staff to interfere with study involvement.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pain Coping Information
Participants will be randomized to listen to a 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).
Behavioral: Pain Coping Information
A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).
Experimental: Mindful Pain Management
Participants will be randomized to listen to a 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.
Behavioral: Mindful Pain Management
A 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.

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
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
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
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
Immediately before to after 4-minute audio recording
Change in Anxiety Numeric Rating Scale
Time Frame: Immediately before to after 4-minute audio recording
Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety.
Immediately before to after 4-minute audio recording
Change in Depression Numeric Rating Scale
Time Frame: Immediately before to after 4-minute audio recording]
Single Likert scale item ranging from 0-10, with 0 indicating no depression and 10 indicating severe depression.
Immediately before to after 4-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)

November 13, 2023

Primary Completion (Actual)

December 4, 2024

Study Completion (Actual)

December 4, 2024

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

June 19, 2025

Last Update Submitted That Met QC Criteria

June 16, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • IRB_00085446 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data is aggregated and anonymous.

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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