App Delivered Brief Mindfulness Intervention for Surgical Patients

NCT ID: NCT05433389

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

823 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-21

Study Completion Date

2025-11-01

Brief Summary

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This will be a single-site, five-arm, parallel group randomized control trial involving patients undergoing knee or hip replacement surgery. The investigators will compare five different styles of 5-minute, audio-recoded mindfulness practices delivered via app 7 days before to surgery, 2 days before to surgery, 2 days after surgery, and 6 days after surgery.

Detailed Description

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Conditions

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Pain Anxiety State Depressive State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Breath Counting

Group Type ACTIVE_COMPARATOR

Breath Counting

Intervention Type BEHAVIORAL

Patients will listen to a 5-minute, audio-recorded breath counting practice.

Body Scan

Group Type EXPERIMENTAL

Body Scan

Intervention Type BEHAVIORAL

Patients will listen to a 5-minute, audio-recorded body scan practice.

Mindful Breathing

Group Type EXPERIMENTAL

Mindful Breathing

Intervention Type BEHAVIORAL

Patients will listen to a 5-minute, audio-recorded mindful breathing practice.

Mindfulness of Pain

Group Type EXPERIMENTAL

Mindfulness of Pain

Intervention Type BEHAVIORAL

Patients will listen to a 5-minute, audio-recorded mindfulness of pain practice.

Mindful Savoring

Group Type EXPERIMENTAL

Mindful Savoring

Intervention Type BEHAVIORAL

Patients will listen to a 5-minute, audio-recorded mindful savoring practice.

Interventions

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Breath Counting

Patients will listen to a 5-minute, audio-recorded breath counting practice.

Intervention Type BEHAVIORAL

Body Scan

Patients will listen to a 5-minute, audio-recorded body scan practice.

Intervention Type BEHAVIORAL

Mindful Breathing

Patients will listen to a 5-minute, audio-recorded mindful breathing practice.

Intervention Type BEHAVIORAL

Mindfulness of Pain

Patients will listen to a 5-minute, audio-recorded mindfulness of pain practice.

Intervention Type BEHAVIORAL

Mindful Savoring

Patients will listen to a 5-minute, audio-recorded mindful savoring practice.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥18,
* Scheduled to undergo total joint arthroplasty of the knee or hip

Exclusion Criteria

* Inability to read English
* Cognitive impairment preventing completion of study procedures
Minimum Eligible Age

18 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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00085446 AM_00032203

Identifier Type: -

Identifier Source: org_study_id

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