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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Behavioral: Mindfulness; Behavioral: Suggestion; Behavioral: Psychoeducation

• Study Type: Interventional
• Enrollment (Actual): 727
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; 15 minute mindfulness session	Behavioral: 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.
Experimental: Suggestion; 15 minute therapeutic suggestion session	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.
Active Comparator: Psychoeducation; 15 minute psychoeducation session	Behavioral: Psychoeducation; The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately prior to and following intervention
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.	Immediately prior to and following intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately prior to and following intervention
Anxiety Numeric Rating Scale	Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing very anxious.	Immediately prior to and following intervention
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.	During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment.
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.	Immediately prior to and following intervention
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.	Immediately prior to and following intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Present Moment Awareness Numeric Rating Scale (Manipulation Check)	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.	Immediately prior to and following intervention
Decentering Numeric Rating Scale (Manipulation Check)	Single Likert scale item ranging from 0-10, with 0 indicating no decentering and 10 representing a completely decentered perspective.	Immediately prior to and following intervention

Collaborators and Investigators

• Sponsor: University of Utah

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): September 23, 2019
• Study Completion (Actual): September 23, 2019

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 23, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: IRB_00085446

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No