Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention

Sponsor
University of Utah (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05054595
Collaborator
(none)
66
3
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Standard Pain Management
  • Behavioral: Audio-Recorded Mindfulness-Based Intervention
  • Behavioral: Nurse-Led Mindfulness-Based Intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 20, 2021
Anticipated Primary Completion Date :
Feb 20, 2022
Anticipated Study Completion Date :
Sep 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Pain Psychoeducation

Behavioral: Standard Pain Management
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.

Active Comparator: Audio-Recorded Mindfulness-Based Intervention

Behavioral: Audio-Recorded 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.

Experimental: Nurse-Led Mindfulness-Based Intervention

Behavioral: Nurse-Led Mindfulness-Based Intervention
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.

Outcome Measures

Primary Outcome Measures

  1. Change in Pain Intensity Numeric Rating Scale [Baseline and after the 10 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 Outcome Measures

  1. Change in Pain Unpleasantness Numeric Rating Scale [Baseline and after the 10 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.

  2. Change in Pain Medication Desire Numeric Rating Scale [Baseline and after the 10 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.

Other Outcome Measures

  1. 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 indicates better physical functioning.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Age ≥18,
    1. Scheduled to undergo unilateral total knee or hip arthroplasty
Exclusion Criteria:
    1. Cognitive impairment preventing completion of study procedures.
    1. Current cancer diagnosis,
    1. Contralateral knee or hip replaced in the previous 3 months,
    1. Intent to have contralateral knee or hip replaced or other, additional surgical procedure during the study period,
    1. Intent to add new pain treatments during the study period (except for what is part of the study),
    1. Other unstable illness judged by medical staff to interfere with study treatment.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adam Hanley, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier:
NCT05054595
Other Study ID Numbers:
  • IRB_00085446: AM_00040605 2
First Posted:
Sep 23, 2021
Last Update Posted:
Sep 23, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 23, 2021