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

NCT ID: NCT05054595

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2022-09-20

Brief Summary

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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

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Conditions

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Pain Osteoarthritis, Knee Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Standard Pain Psychoeducation

Group Type ACTIVE_COMPARATOR

Standard Pain Management

Intervention Type 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.

Audio-Recorded Mindfulness-Based Intervention

Group Type ACTIVE_COMPARATOR

Audio-Recorded Mindfulness-Based Intervention

Intervention Type 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.

Nurse-Led Mindfulness-Based Intervention

Group Type EXPERIMENTAL

Nurse-Led Mindfulness-Based Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Adam Hanley

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IRB_00085446: AM_00040605 2

Identifier Type: -

Identifier Source: org_study_id

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