Brief Nurse-led Mindfulness Based Intervention
1 other identifier
interventional
127
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2021
CompletedFirst Submitted
Initial submission to the registry
March 7, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2022
CompletedJanuary 11, 2022
January 1, 2022
3 months
March 7, 2021
January 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in Pain Unpleasantness Numeric Rating Scale
baseline and after the 15 minute preoperative nurse visit
Change in Pain Medication Desire Numeric Rating Scale
baseline and after the 15 minute preoperative nurse visit
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
Study Arms (2)
Nurse-led Mindfulness Based Intervention
EXPERIMENTALNurse-led Pain Psychoeducation
ACTIVE COMPARATORInterventions
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.
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 Criteria
You may qualify if:
- \) Age ≥18,
- \) Scheduled to undergo unilateral total knee arthroplasty
You may not qualify if:
- \) Cognitive impairment preventing completion of study procedures.
- \) Current cancer diagnosis,
- \) Contralateral knee replaced in the previous 3 months,
- \) Intent to have contralateral knee replaced or other, additional surgical procedure during the study period,
- \) Intent to add new pain treatments during the study period (except for what is part of the study),
- \) Other unstable illness judged by medical staff to interfere with study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 7, 2021
First Posted
March 16, 2021
Study Start
February 22, 2021
Primary Completion
May 20, 2021
Study Completion
January 10, 2022
Last Updated
January 11, 2022
Record last verified: 2022-01