Brief Mindfulness Intervention for Orthopedic Patients: Mechanistic Investigation

Not Applicable

Suspended

• Conditions: Pain

• Registration Number: NCT06171009
• Lead Sponsor: Florida State University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-14
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Study Start: 2024-12-07
• Primary Completion: 2025-03-07
• Study Completion: 2025-03-07

Recruitment & Eligibility

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

Inclusion Criteria

• Age ≥18
• 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.

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 Self-Transcendent State	Immediately before to after 4-minute audio recording	Self-transcendent state will be measured by the three-item, state version of the validated Nondual Awareness Dimensional Assessment. These three items will be scored with a Likert scale item ranging from 0-10, with higher scores representing greater self-transcendence.
Change in Decentering	Immediately before to after 4-minute audio recording	Decentering will be measured by the single, decentering item from the state version of the validated Metacognitive Processes of Decentering Scale. This item will be scored with a Likert scale item ranging from 0-10, with higher scores representing greater decentering.

Trial Locations

Locations (1)

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