Brief Mindfulness Intervention for Orthopedic Patients

Not Applicable

Completed

• Conditions: Pain

• Registration Number: NCT06099964
• Lead Sponsor: Florida State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-25
• Study Start: 2023-11-13
• Primary Completion: 2024-12-04
• Study Completion: 2024-12-04
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain Unpleasantness Numeric Rating Scale	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.

Secondary Outcome Measures

Name	Time	Method
Change in Pain Intensity Numeric Rating Scale	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.
Change in Depression Numeric Rating Scale	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.
Change in Anxiety Numeric Rating Scale	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.

Trial Locations

Locations (1)

Tallahassee Orthopedic Clinic (TOC); 🇺🇸 Tallahassee, Florida, United States