Psychosocial Support for Pre-operative Pain and Distress

NCT ID: NCT03665727

Last Updated: 2020-05-27

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

727 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2019-09-23

Brief Summary

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The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients. This study will examine the differential effects of brief mindfulness training, hypnostic suggestion, and cognitive behavioral pain psychoeducation for pre-operative patients, with a supplemental nonrandomized usual care comparison group.

Detailed Description

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Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Clinical assessors were masked at postoperative follow-up

Study Groups

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Mindfulness

15 minute mindfulness session

Group Type EXPERIMENTAL

Mindfulness

Intervention Type BEHAVIORAL

The 15 minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experience in a non-judgmental fashion.

Suggestion

15 minute therapeutic suggestion session

Group Type EXPERIMENTAL

Suggestion

Intervention Type BEHAVIORAL

The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.

Psychoeducation

15 minute psychoeducation session

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.

Usual Care

The usual care comparison group was comprised of patients who underwent total joint arthroplasty of the hip or knee at the same academic medical center during the study period but who did not attend Joint Academy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness

The 15 minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experience in a non-judgmental fashion.

Intervention Type BEHAVIORAL

Suggestion

The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.

Intervention Type BEHAVIORAL

Psychoeducation

The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.

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 the Joint Replacement 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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Eric Garland

Associate Dean for Research College of Social Work Director; Center on Mindfulness and Integrative Health Intervention Development (C-MIIND)

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)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB_00085446

Identifier Type: -

Identifier Source: org_study_id

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