Brief Mindfulness Intervention for Orthopedic Patients: Mechanistic Investigation

Florida State University158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

158

Conditions

Pain

Interventions

Pain Coping InformationBEHAVIORAL

A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).

Mindful Pain ManagementBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Tallahassee Orthopedic Clinic (TOC)

Tallahassee, Florida, United States

Outcomes

Primary Outcomes

Change in Pain Unpleasantness Numeric Rating Scale

Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.

Time frame: Immediately before to after 4-minute audio recording

Secondary Outcomes

Change in Pain Intensity Numeric Rating Scale

Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.

Time frame: Immediately before to after 4-minute audio recording

Change in Decentering

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.

Time frame: Immediately before to after 4-minute audio recording

Change in Self-Transcendent State

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.

Time frame: Immediately before to after 4-minute audio recording

Data from ClinicalTrials.gov

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