Osteoarthritis, Hip, Osteoarthritis, Knee, Pain
Conditions
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.
Interventions
BEHAVIORALNurse-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.
BEHAVIORALNurse-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.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed