Brief Nurse-led Mindfulness Based Intervention

Not Applicable

Completed

• Conditions: Osteoarthritis, Hip; Pain; Osteoarthritis, Knee

• Registration Number: NCT04800354
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-22
• Study First Submitted: 2021-03-07
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-16
• Primary Completion: 2021-05-20
• Status Verified: 2022-01
• Study Completion: 2022-01-10
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity Numeric Rating Scale	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 Outcome Measures

Name	Time	Method
Change in Pain Unpleasantness Numeric Rating Scale	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 unpleasant pain imaginable.
Change in Pain Medication Desire Numeric Rating Scale	baseline and after the 15 minute preoperative nurse visit	Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication.
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	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 better physical functioning.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States