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Brief Nurse-led Mindfulness Based Intervention

Primary Purpose

Pain, Osteoarthritis, Knee, Osteoarthritis, Hip

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse-led Mindfulness Based Intervention
Nurse-led Pain Psychoeducation
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nurse-led Mindfulness Based Intervention

Nurse-led Pain Psychoeducation

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.
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.

Full Information

First Posted
March 7, 2021
Last Updated
January 10, 2022
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT04800354
Brief Title
Brief Nurse-led Mindfulness Based Intervention
Official Title
Brief Nurse-led Mindfulness Based Intervention Among Patients Scheduled for Knee and Hip Replacement Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
January 10, 2022 (Actual)

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, 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.

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
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse-led Mindfulness Based Intervention
Arm Type
Experimental
Arm Title
Nurse-led Pain Psychoeducation
Arm Type
Active Comparator
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 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.
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led Pain Psychoeducation
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.
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 15 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 15 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 15 minute preoperative nurse visit
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 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 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.
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

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Brief Nurse-led Mindfulness Based Intervention

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