Brief Nurse-led Mindfulness Based Intervention

NCT ID: NCT04800354

Last Updated: 2022-01-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2022-01-10

Brief Summary

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This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The feasibility, acceptability, and clinical effects of the nurse-led, very brief, preoperative mindfulness based intervention for hip and knee replacement patients will be investigated relative to nurse-led preoperative pain psychoeducation.

A secondary sub-analysis will compare two different styles of mindfulness practice (mindfulness of breath vs. mindfulness of pain) relative to preoperative pain psychoeducation.

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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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 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 they experience intense pain or take pain medication before and after surgery.

Nurse-led Pain Psychoeducation

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.

Nurse-led Pain Psychoeducation

Group Type ACTIVE_COMPARATOR

Nurse-led Pain Psychoeducation

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.

Interventions

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Nurse-led 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 they experience intense pain or take pain medication before and after surgery.

Intervention Type BEHAVIORAL

Nurse-led Pain Psychoeducation

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

Eligibility Criteria

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Inclusion Criteria

* 1\) Age ≥18,
* 2\) Scheduled to undergo unilateral total knee arthroplasty

Exclusion Criteria

* 1\) Cognitive impairment preventing completion of study procedures.
* 2\) Current cancer diagnosis,
* 3\) Contralateral knee replaced in the previous 3 months,
* 4\) Intent to have contralateral knee 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

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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IRB_00085446: AM_00040605

Identifier Type: -

Identifier Source: org_study_id

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