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Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

Primary Purpose

Pain, Acute, Pain, Joint, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness of Breath
Mindfulness of Pain
Cognitive-Behaviorally Based Pain Psychoeducation
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Mindfulness of Breath

Mindfulness of Pain

Cognitive-Behaviorally Based Pain Psychoeducation

Arm Description

Outcomes

Primary Outcome Measures

Change in Preoperative Pain Intensity
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
Change in Postoperative Pain Intensity
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.

Secondary Outcome Measures

Change in Postoperative Pain Unpleasantness
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Change in Postoperative Opioid Use
Single-item, dichotomously scored (no vs. yes): "Did you take opioid medications in the last 24 hours?"

Full Information

First Posted
August 13, 2020
Last Updated
August 24, 2020
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT04520958
Brief Title
Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy
Official Title
Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
August 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Pain, Joint, Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness of Breath
Arm Type
Experimental
Arm Title
Mindfulness of Pain
Arm Type
Experimental
Arm Title
Cognitive-Behaviorally Based Pain Psychoeducation
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness of Breath
Intervention Description
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
Intervention Name(s)
Mindfulness of Pain
Intervention Description
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
Intervention Name(s)
Cognitive-Behaviorally Based Pain Psychoeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Preoperative Pain Intensity
Description
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
Time Frame
Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
Title
Change in Postoperative Pain Intensity
Description
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
Time Frame
Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Secondary Outcome Measure Information:
Title
Change in Postoperative Pain Unpleasantness
Description
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Time Frame
Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Title
Change in Postoperative Opioid Use
Description
Single-item, dichotomously scored (no vs. yes): "Did you take opioid medications in the last 24 hours?"
Time Frame
Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Other Pre-specified Outcome Measures:
Title
Change in Self-Transcendent State
Description
Self-transcendent state was measured with the Nondual Awareness Dimensional Assessment (NADAs; Hanley, Nakamura, & Garland, 2018). The NADAs is a 3-item, Likert type (0-10) self-report scale specifically designed to measure alterations in the experience of self occasioned by mindfulness practice.
Time Frame
Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
Title
Patient Confidence
Description
Patients' confidence ("How confident are you that you could effectively use this pain management technique?") in using the pain management technique was assessed with a single item rated on a numeric rating scale (0-10), with 0 indicating no confidence and 10 representing complete confidence.
Time Frame
Completed immediately after the preoperative intervention
Title
Patient Intent
Description
Patients' intent to use the technique ("How likely are you to use this pain management technique?") to use the pain management technique was assessed with a single item rated on a numeric rating scale (0-10), with 0 indicating no intent and 10 representing absolute intent.
Time Frame
Completed immediately after the preoperative intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34165999
Citation
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.
Results Reference
derived

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Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

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