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Clinical Trials/NCT04800354
NCT04800354
Completed
Not Applicable

Brief Nurse-led Mindfulness Based Intervention Among Patients Scheduled for Knee and Hip Replacement Surgery

University of Utah1 site in 1 country127 target enrollmentFebruary 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
University of Utah
Enrollment
127
Locations
1
Primary Endpoint
Change in Pain Intensity Numeric Rating Scale
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The feasibility, acceptability, and clinical effects of the nurse-led, very brief, preoperative mindfulness based intervention for hip and knee replacement patients will be investigated relative to nurse-led preoperative pain psychoeducation.

A secondary sub-analysis will compare two different styles of mindfulness practice (mindfulness of breath vs. mindfulness of pain) relative to preoperative pain psychoeducation.

Registry
clinicaltrials.gov
Start Date
February 22, 2021
End Date
January 10, 2022
Last Updated
4 years 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

  • Age ≥18,
  • Scheduled to undergo unilateral total knee arthroplasty

Exclusion Criteria

  • Cognitive impairment preventing completion of study procedures.
  • Current cancer diagnosis,
  • Contralateral knee replaced in the previous 3 months,
  • Intent to have contralateral knee replaced or other, additional surgical procedure during the study period,
  • Intent to add new pain treatments during the study period (except for what is part of the study),
  • Other unstable illness judged by medical staff to interfere with study treatment.

Outcomes

Primary Outcomes

Change in Pain Intensity Numeric Rating Scale

Time Frame: baseline and after the 15 minute preoperative nurse visit

Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.

Secondary Outcomes

  • Change in Pain Unpleasantness Numeric Rating Scale(baseline and after the 15 minute preoperative nurse visit)
  • Change in Pain Medication Desire Numeric Rating Scale(baseline and after the 15 minute preoperative nurse visit)
  • Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0(During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment)

Study Sites (1)

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