Back to resultsAudio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention
Primary Purpose
Pain, Osteoarthritis, Knee, Osteoarthritis, Hip
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard Pain Management
Audio-Recorded Mindfulness-Based Intervention
Nurse-Led Mindfulness-Based Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria:
- 1) Age ≥18,
- 2) Scheduled to undergo unilateral total knee or hip arthroplasty
Exclusion Criteria:
- 1) Cognitive impairment preventing completion of study procedures.
- 2) Current cancer diagnosis,
- 3) Contralateral knee or hip replaced in the previous 3 months,
- 4) Intent to have contralateral knee or hip 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Standard Pain Psychoeducation
Audio-Recorded Mindfulness-Based Intervention
Nurse-Led Mindfulness-Based Intervention
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05054595
Brief Title
Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention
Official Title
Comparing the Effects of an Audio-Recorded Brief Mindfulness-Based Intervention With a Nurse-Led Brief Mindfulness-Based Intervention for Preoperative Knee and Hip Replacement Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of provider bandwidth
Study Start Date
September 20, 2021 (Anticipated)
Primary Completion Date
February 20, 2022 (Anticipated)
Study Completion Date
September 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a nurse-led, very brief, preoperative mindfulness-based intervention for hip and knee replacement patients will be investigated relative to an audio-recorded very brief, preoperative mindfulness-based intervention delivered during the standard nurse consult and a nurse-led preoperative pain psychoeducation intervention during the standard nurse consult.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Osteoarthritis, Knee, Osteoarthritis, Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Pain Psychoeducation
Arm Type
Active Comparator
Arm Title
Audio-Recorded Mindfulness-Based Intervention
Arm Type
Active Comparator
Arm Title
Nurse-Led Mindfulness-Based Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Standard Pain Management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Audio-Recorded Mindfulness-Based Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nurse-Led Mindfulness-Based Intervention
Intervention Description
Nurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then guide them through a very brief (1 minute 30 second) 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.
Primary Outcome Measure Information:
Title
Change in Pain Intensity Numeric Rating Scale
Description
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 10 minute preoperative nurse visit
Secondary Outcome Measure Information:
Title
Change in Pain Unpleasantness Numeric Rating Scale
Description
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 10 minute preoperative nurse visit
Title
Change in Pain Medication Desire Numeric Rating Scale
Description
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 10 minute preoperative nurse visit
Other Pre-specified Outcome Measures:
Title
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
Description
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 indicates better physical functioning.
Time Frame
During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) Age ≥18,
2) Scheduled to undergo unilateral total knee or hip arthroplasty
Exclusion Criteria:
1) Cognitive impairment preventing completion of study procedures.
2) Current cancer diagnosis,
3) Contralateral knee or hip replaced in the previous 3 months,
4) Intent to have contralateral knee or hip 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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention
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