Brief Mindfulness Intervention for a Heterogenous Mix of Orthopedic Patients

Florida State University1 site in 1 country80 target enrollmentNovember 13, 2023

ConditionsPain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pain
Sponsor: Florida State University
Enrollment: 80
Locations: 1
Primary Endpoint: Change in Pain Unpleasantness Numeric Rating Scale
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 13, 2023

End Date

December 4, 2024

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Florida State University

Responsible Party

Principal Investigator

Adam Hanley

Principal Investigator

Florida State University

Eligibility Criteria

Inclusion Criteria

•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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Change in Anxiety Numeric Rating Scale(Immediately before to after 4-minute audio recording)
Change in Pain Intensity Numeric Rating Scale(Immediately before to after 4-minute audio recording)
Change in Depression Numeric Rating Scale(Immediately before to after 4-minute audio recording])