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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05054595
Other study ID # IRB_00085446: AM_00040605 2
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 20, 2021
Est. completion date September 20, 2022

Study information

Verified date March 2023
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 20, 2022
Est. primary completion date February 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.
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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Outcome

Type Measure Description Time frame Safety issue
Other 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 indicates better physical functioning.
During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment
Primary 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 10 minute preoperative nurse visit
Secondary 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. Baseline and after the 10 minute preoperative nurse visit
Secondary 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. Baseline and after the 10 minute preoperative nurse visit
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