Anxiety & Depression Association of America

Mindfulness Intervention in Orthopedic Trauma Patients

Purpose

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.

Conditions

Pain
Anxiety

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Placebo Comparator Mind wandering		Behavioral: Mind wandering A timed, seven-minute mind wandering period during which participants are instructed: "For the next 7 minutes, allow your mind to wander."
Active Comparator Preoperative Mindfulness	Participants will only listen to the guided meditation practice before surgery.	Behavioral: Preoperative mindfulness A seven-minute, audio-guided, mindfulness meditation practice. Behavioral: Mind wandering A timed, seven-minute mind wandering period during which participants are instructed: "For the next 7 minutes, allow your mind to wander."
Active Comparator Preoperative and Postoperative Mindfulness	Participant will listen to the guided meditation practice before surgery and during their hospital stay after surgery.	Behavioral: Preoperative mindfulness A seven-minute, audio-guided, mindfulness meditation practice. Behavioral: Postoperative mindfulness A seven-minute, audio-guided, mindfulness meditation practice.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of Utah

Study Contact

Adam W Hanley
8012134191
adam.hanley@utah.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.