Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

NCT ID: NCT04520958

Last Updated: 2020-08-27

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

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-29

Study Completion Date

2020-08-13

Brief Summary

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This was a single site, three-arm, parallel group randomized clinical trial that compared the effect of three preoperative psychosocial interventions on knee and hip replacement patients' preoperative pain intensity and postoperative pain intensity, pain unpleasantness, and opioid use.

Detailed Description

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Conditions

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Pain, Acute Pain, Joint Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mindfulness of Breath

Group Type EXPERIMENTAL

Mindfulness of Breath

Intervention Type BEHAVIORAL

Mindfulness of Breath consisted of instruction in focused attention on the breath and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.

Mindfulness of Pain

Group Type EXPERIMENTAL

Mindfulness of Pain

Intervention Type BEHAVIORAL

Mindfulness of Pain consisted of instruction in how to (1) zoom in to deconstruct pain into its constituent physical sensations and precisely map each sensation's spatial location, (2) use mindful breathing to zoom out and broaden the field of attention to include previously neglected sensory elements (i.e., spaces within the body that were absent of sensation and pleasant sensations), and (3) shift attention from unpleasant sensations to neutral/pleasant sensations or experiences.

Cognitive-Behaviorally Based Pain Psychoeducation

Group Type ACTIVE_COMPARATOR

Cognitive-Behaviorally Based Pain Psychoeducation

Intervention Type BEHAVIORAL

Cognitive-Behaviorally Based Pain Psychoeducation consisted of psychoeducation about the link between thoughts, emotions, and behavior and provided instruction in the use logic to dispute maladaptive thoughts about pain that might otherwise exacerbate pain and distress.

Interventions

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Mindfulness of Breath

Mindfulness of Breath consisted of instruction in focused attention on the breath and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.

Intervention Type BEHAVIORAL

Mindfulness of Pain

Mindfulness of Pain consisted of instruction in how to (1) zoom in to deconstruct pain into its constituent physical sensations and precisely map each sensation's spatial location, (2) use mindful breathing to zoom out and broaden the field of attention to include previously neglected sensory elements (i.e., spaces within the body that were absent of sensation and pleasant sensations), and (3) shift attention from unpleasant sensations to neutral/pleasant sensations or experiences.

Intervention Type BEHAVIORAL

Cognitive-Behaviorally Based Pain Psychoeducation

Cognitive-Behaviorally Based Pain Psychoeducation consisted of psychoeducation about the link between thoughts, emotions, and behavior and provided instruction in the use logic to dispute maladaptive thoughts about pain that might otherwise exacerbate pain and distress.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* English-speaking males or females.
* 18 years old or older
* Patients within the University of Utah Hospital system
* Patients attending Joint Academy to prepare for either hip or knee replacement surgery

Exclusion Criteria

* Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.
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

References

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Hanley AW, Gililland J, Garland EL. To be mindful of the breath or pain: Comparing two brief preoperative mindfulness techniques for total joint arthroplasty patients. J Consult Clin Psychol. 2021 Jul;89(7):590-600. doi: 10.1037/ccp0000657. Epub 2021 Jun 24.

Reference Type DERIVED
PMID: 34165999 (View on PubMed)

Other Identifiers

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IRB_00123611

Identifier Type: -

Identifier Source: org_study_id

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