App Delivered Brief Mindfulness Intervention for Surgical Patients

App Delivered Brief Mindfulness Intervention for Knee or Hip Replacement Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Anxiety State; Depressive State
• Intervention / Treatment: Behavioral: Body Scan; Behavioral: Mindful Breathing; Behavioral: Mindful Savoring; Behavioral: Breath Counting; Behavioral: Mindfulness of Pain

• Study Type: Interventional
• Enrollment (Estimated): 823
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Breath Counting	Behavioral: Breath Counting; Patients will listen to a 5-minute, audio-recorded breath counting practice.
Experimental: Body Scan	Behavioral: Body Scan; Patients will listen to a 5-minute, audio-recorded body scan practice.
Experimental: Mindful Breathing	Behavioral: Mindful Breathing; Patients will listen to a 5-minute, audio-recorded mindful breathing practice.
Experimental: Mindfulness of Pain	Behavioral: Mindfulness of Pain; Patients will listen to a 5-minute, audio-recorded mindfulness of pain practice.
Experimental: Mindful Savoring	Behavioral: Mindful Savoring; Patients will listen to a 5-minute, audio-recorded mindful savoring practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 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.	Immediately before to after 5-minute audio recording

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 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.	Immediately before to after 5-minute audio recording
Change in Pain Medication Desire	Single item assessing pain unpleasantness ("How much do you want pain medicine?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater desire for pain medicine.	Immediately before to after 5-minute audio recording

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 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.	Immediately before to after 5-minute audio recording
Change in Depression	Single item assessing pain unpleasantness ("How down, depressed, or uninterested in life do you feel?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater depression.	Immediately before to after 5-minute audio recording
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0	The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score reflects better physical functioning.	During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Actual): May 26, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 00085446 AM_00032203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No