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

NCT05054595 | Withdrawn

• 1 other identifier: IRB_00085446: AM_00040605 2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Osteoarthritis, Knee; Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Pain Unpleasantness Numeric Rating Scale

  Baseline and after the 10 minute preoperative nurse visit

• Change in Pain Medication Desire Numeric Rating Scale

  Baseline and after the 10 minute preoperative nurse visit

Other Outcomes (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

Study Arms (3)

Standard Pain Psychoeducation

ACTIVE COMPARATOR

Behavioral: Standard Pain Management

Audio-Recorded Mindfulness-Based Intervention

ACTIVE COMPARATOR

Behavioral: Audio-Recorded Mindfulness-Based Intervention

Nurse-Led Mindfulness-Based Intervention

EXPERIMENTAL

Behavioral: Nurse-Led Mindfulness-Based Intervention

Interventions

Standard Pain Management BEHAVIORAL

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.

Standard Pain Psychoeducation

Audio-Recorded Mindfulness-Based Intervention BEHAVIORAL

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.

Audio-Recorded Mindfulness-Based Intervention

Nurse-Led Mindfulness-Based Intervention BEHAVIORAL

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.

Nurse-Led Mindfulness-Based Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age ≥18,
• \) Scheduled to undergo unilateral total knee or hip arthroplasty

You may not qualify if:

• \) Cognitive impairment preventing completion of study procedures.
• \) Current cancer diagnosis,
• \) Contralateral knee or hip replaced in the previous 3 months,
• \) Intent to have contralateral knee or hip replaced or other, additional surgical procedure during the study period,
• \) Intent to add new pain treatments during the study period (except for what is part of the study),
• \) Other unstable illness judged by medical staff to interfere with study treatment.

Sponsors & Collaborators

• University of Utah: lead

MeSH Terms

Conditions

Pain; Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 23, 2021
• Study Start: September 20, 2021
• Primary Completion: February 20, 2022
• Study Completion: September 20, 2022
• Last Updated: March 31, 2023

Record last verified: 2023-03