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

Not Applicable

Withdrawn

• Conditions: Pain; Osteoarthritis, Hip; Osteoarthritis, Knee
• Interventions: Behavioral: Standard Pain Management; Behavioral: Audio-Recorded Mindfulness-Based Intervention; Behavioral: Nurse-Led Mindfulness-Based Intervention

• Registration Number: NCT05054595
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-13
• Study Start: 2021-09-20
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-09-23
• Primary Completion: 2022-02-20
• Study Completion: 2022-09-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Pain Psychoeducation	Standard Pain Management	-
Audio-Recorded Mindfulness-Based Intervention	Audio-Recorded Mindfulness-Based Intervention	-
Nurse-Led Mindfulness-Based Intervention	Nurse-Led Mindfulness-Based Intervention	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.