Mindfulness Intervention in Orthopedic Trauma Patients

University of Utah94 enrolled

Overview

This project a single-site 3-arm parallel group randomized clinical trial conducted at a tertiary level 1 trauma center among patients undergoing operative fixation of a lower extremity fracture.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain Anxiety

Interventions

Preoperative mindfulnessBEHAVIORAL

A seven-minute, audio-guided, mindfulness meditation practice.

Postoperative mindfulnessBEHAVIORAL

A seven-minute, audio-guided, mindfulness meditation practice.

Mind wanderingBEHAVIORAL

A timed, seven-minute mind wandering period during which participants are instructed: "For the next 7 minutes, allow your mind to wander."

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age at presentation between 18 and 65 years * Acute lower extremity fracture to be operatively managed * Glasgow Coma Scale of 15 * English speaking * Willingness to participate in study Exclusion Criteria: * Cognitive impairment * Pregnant or lactating woman * Current incarceration * Planned secondary procedure

Locations (1)

University of Utah

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Change in Preoperative Anxiety

Single item assessing pain unpleasantness ("How nervous, anxious, or on edge do you feel?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater anxiety.

Time frame: Immediately before to after the 7-minute preoperative intervention

Change in Postoperative, In-patient Pain Unpleasantness

Single item assessing pain unpleasantness ("How unpleasant is your pain?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain unpleasantness.

Time frame: Immediately before to after the 7-minute postoperative intervention

Secondary Outcomes

Change in Preoperative Pain Intensity

Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain intensity.

Time frame: Immediately before to after the 7-minute preoperative intervention

Change in Postoperative, In-patient Pain Intensity

Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain intensity.

Time frame: Immediately before to after the 7-minute postoperative intervention

Change in Preoperative Pain Unpleasantness

Single item assessing pain unpleasantness ("How unpleasant is your pain?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain unpleasantness.

Time frame: Immediately before to after the 7-minute preoperative intervention

Change in Postoperative, In-patient Anxiety

Data from ClinicalTrials.gov

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