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

Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05054595
• Other study ID #: IRB_00085446: AM_00040605 2
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Pain

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