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

Utah System of Higher Education (USHE)

Status: Withdrawn

Conditions: Osteoarthritis, Hip; Pain; Osteoarthritis, Knee

Treatments: Behavioral: Nurse-Led Mindfulness-Based Intervention; Behavioral: Standard Pain Management; Behavioral: Audio-Recorded Mindfulness-Based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05054595

IRB_00085446: AM_00040605 2

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Standard Pain Psychoeducation

Active Comparator group

Treatment:

Behavioral: Standard Pain Management

Audio-Recorded Mindfulness-Based Intervention

Active Comparator group

Treatment:

Behavioral: Audio-Recorded Mindfulness-Based Intervention

Nurse-Led Mindfulness-Based Intervention

Experimental group

Treatment:

Behavioral: Nurse-Led Mindfulness-Based Intervention