Brief Nurse-led Mindfulness Based Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Osteoarthritis, Knee; Osteoarthritis, Hip
• Intervention / Treatment: Behavioral: Nurse-led Mindfulness Based Intervention; Behavioral: Nurse-led Pain Psychoeducation

• Study Type: Interventional
• Enrollment (Actual): 127
• 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
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nurse-led Mindfulness Based Intervention	Behavioral: Nurse-led Mindfulness Based Intervention; Nurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then have them listen to a very brief (1 minute 30 second) guided mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time they experience intense pain or take pain medication before and after surgery.; Behavioral: Nurse-led Pain Psychoeducation; Nurses will provide psychoeducation about pain along with common pain coping strategies, such as rest, ice, and elevation, for use any time they experience intense pain or take pain medication before and after surgery.
ACTIVE_COMPARATOR: Nurse-led Pain Psychoeducation	Behavioral: Nurse-led Pain Psychoeducation; Nurses will provide psychoeducation about pain along with common pain coping strategies, such as rest, ice, and elevation, for use any time they experience intense pain or take pain medication before and after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity Numeric Rating Scale	Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.	baseline and after the 15 minute preoperative nurse visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Unpleasantness Numeric Rating Scale	Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.	baseline and after the 15 minute preoperative nurse visit
Change in Pain Medication Desire Numeric Rating Scale	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.	baseline and after the 15 minute preoperative nurse visit
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 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): February 22, 2021
• Primary Completion (ACTUAL): May 20, 2021
• Study Completion (ACTUAL): January 10, 2022

Study Registration Dates

• First Submitted: March 7, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (ACTUAL): March 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: IRB_00085446: AM_00040605

Drug and device information, study documents

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