Brief Mindfulness Intervention for Orthopedic Patients in the Clinic Waiting Room: Mechanistic Investigation

Florida State University1 site in 1 country80 target enrollmentDecember 7, 2024

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: Suspended
Last Updated: 2 years 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 analgesic 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. Analgesic mechanisms of mindfulness will also be investigated.

Registry

clinicaltrials.gov

Start Date

December 7, 2024

End Date

March 7, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Florida State University

Responsible Party

Principal Investigator

Adam Hanley

Associate Professor

Florida State University

Eligibility Criteria

Inclusion Criteria

•Seeking treatment at the Tallahassee Orthopedic Center

Exclusion Criteria

•Cognitive impairment preventing completion of study procedures.
•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 Pain Intensity Numeric Rating Scale(Immediately before to after 4-minute audio recording)
Change in Self-Transcendent State(Immediately before to after 4-minute audio recording)
Change in Decentering(Immediately before to after 4-minute audio recording)