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Clinical Trials/NCT05433389
NCT05433389
Active, not recruiting
Not Applicable

App Delivered Brief Mindfulness Intervention for Knee or Hip Replacement Patients

University of Utah1 site in 1 country823 target enrollmentJune 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
University of Utah
Enrollment
823
Locations
1
Primary Endpoint
Change in Pain Unpleasantness
Status
Active, not recruiting
Last Updated
10 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 21, 2022
End Date
November 1, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adam Hanley

Assistant Professor

University of Utah

Eligibility Criteria

Inclusion Criteria

  • Scheduled to undergo total joint arthroplasty of the knee or hip

Exclusion Criteria

  • Inability to read English
  • Cognitive impairment preventing completion of study procedures

Outcomes

Primary Outcomes

Change in Pain Unpleasantness

Time Frame: Immediately before to after 5-minute audio recording

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.

Secondary Outcomes

  • Change in Pain Intensity(Immediately before to after 5-minute audio recording)
  • Change in Pain Medication Desire(Immediately before to after 5-minute audio recording)

Study Sites (1)

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