Brief Nurse-led Mindfulness Based Intervention

University of Utah127 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

127

Conditions

Pain Osteoarthritis, Knee Osteoarthritis, Hip

Interventions

Nurse-led Mindfulness Based InterventionBEHAVIORAL

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.

Nurse-led Pain PsychoeducationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Utah

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.