Mindfulness Intervention in Orthopedic Trauma Patients

NCT ID: NCT05634278

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2023-11-27

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mind wandering

Group Type PLACEBO_COMPARATOR

Mind wandering

Intervention Type BEHAVIORAL

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

Preoperative Mindfulness

Participants will only listen to the guided meditation practice before surgery.

Group Type ACTIVE_COMPARATOR

Preoperative mindfulness

Intervention Type BEHAVIORAL

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

Mind wandering

Intervention Type BEHAVIORAL

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

Preoperative and Postoperative Mindfulness

Participant will listen to the guided meditation practice before surgery and during their hospital stay after surgery.

Group Type ACTIVE_COMPARATOR

Preoperative mindfulness

Intervention Type BEHAVIORAL

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

Postoperative mindfulness

Intervention Type BEHAVIORAL

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

Interventions

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Preoperative mindfulness

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

Intervention Type BEHAVIORAL

Postoperative mindfulness

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

Intervention Type 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."

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Adam Hanley

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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IRB_00085446 AM_00046459

Identifier Type: -

Identifier Source: org_study_id

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