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Psychosocial Support for Pre-operative Pain and Distress (Mind-Body JRA)

Primary Purpose

Acute Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Suggestion
Psychoeducation
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

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 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.

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

Mindfulness

Suggestion

Psychoeducation

Usual Care

Arm Description

15 minute mindfulness session

15 minute therapeutic suggestion session

15 minute psychoeducation session

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.

Outcomes

Primary Outcome Measures

Pain Intensity Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
Pain Unpleasantness Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.

Secondary Outcome Measures

Pain Medication Desire Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication.
Anxiety Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing very anxious.
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score better physical functioning.
Nondual Awareness Dimensional Assessment - State
Three Likert scale item ranging from 0-30, with 0 indicating no nondual awareness and 10 representing complete nondual awareness. Items can also be used individually. Item one is a single Likert scale item ranging from 0-10, with 0 indicating no relational unity and 10 representing complete relational unity. Item two is a single Likert scale item ranging from 0-10, with 0 indicating no annihilational unity and 10 representing complete annihilational unity. Item three is a single Likert scale item ranging from 0-10, with 0 indicating no bliss and 10 representing complete bliss.
Sensation Manikin Body Sensation Report
The ratio of pleasant to unpleasant bodily sensations reported on a sensation manikin. Ratio scores below 1 indicate unpleasant sensations predominate in the body and ratio scores above 1 indicate pleasant scores predominate.

Full Information

First Posted
June 12, 2018
Last Updated
May 23, 2020
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03665727
Brief Title
Psychosocial Support for Pre-operative Pain and Distress
Acronym
Mind-Body JRA
Official Title
Psychosocial Support for Pre-operative Pain and Distress
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
September 23, 2019 (Actual)
Study Completion Date
September 23, 2019 (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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Clinical assessors were masked at postoperative follow-up
Allocation
Randomized
Enrollment
727 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
15 minute mindfulness session
Arm Title
Suggestion
Arm Type
Experimental
Arm Description
15 minute therapeutic suggestion session
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
15 minute psychoeducation session
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
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
Intervention Name(s)
Suggestion
Intervention Description
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
Intervention Name(s)
Psychoeducation
Intervention Description
The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.
Primary Outcome Measure Information:
Title
Pain Intensity Numeric Rating Scale
Description
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
Time Frame
Immediately prior to and following intervention
Title
Pain Unpleasantness Numeric Rating Scale
Description
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Time Frame
Immediately prior to and following intervention
Secondary Outcome Measure Information:
Title
Pain Medication Desire Numeric Rating Scale
Description
Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication.
Time Frame
Immediately prior to and following intervention
Title
Anxiety Numeric Rating Scale
Description
Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing very anxious.
Time Frame
Immediately prior to and following intervention
Title
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
Description
The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score better physical functioning.
Time Frame
During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment.
Title
Nondual Awareness Dimensional Assessment - State
Description
Three Likert scale item ranging from 0-30, with 0 indicating no nondual awareness and 10 representing complete nondual awareness. Items can also be used individually. Item one is a single Likert scale item ranging from 0-10, with 0 indicating no relational unity and 10 representing complete relational unity. Item two is a single Likert scale item ranging from 0-10, with 0 indicating no annihilational unity and 10 representing complete annihilational unity. Item three is a single Likert scale item ranging from 0-10, with 0 indicating no bliss and 10 representing complete bliss.
Time Frame
Immediately prior to and following intervention
Title
Sensation Manikin Body Sensation Report
Description
The ratio of pleasant to unpleasant bodily sensations reported on a sensation manikin. Ratio scores below 1 indicate unpleasant sensations predominate in the body and ratio scores above 1 indicate pleasant scores predominate.
Time Frame
Immediately prior to and following intervention
Other Pre-specified Outcome Measures:
Title
Present Moment Awareness Numeric Rating Scale (Manipulation Check)
Description
Single Likert scale item ranging from 0-10, with 0 indicating no awareness of the present and 10 representing complete awareness of the present moment.
Time Frame
Immediately prior to and following intervention
Title
Decentering Numeric Rating Scale (Manipulation Check)
Description
Single Likert scale item ranging from 0-10, with 0 indicating no decentering and 10 representing a completely decentered perspective.
Time Frame
Immediately prior to and following 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 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.
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

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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Psychosocial Support for Pre-operative Pain and Distress

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