Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

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.

Study Overview

• Status: Completed
• Conditions: Pain; Pain, Acute; Pain, Joint
• Intervention / Treatment: Behavioral: Mindfulness of Breath; Behavioral: Mindfulness of Pain; Behavioral: Cognitive-Behaviorally Based Pain Psychoeducation

• Study Type: Interventional
• Enrollment (Actual): 118
• 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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness of Pain	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.
Experimental: Mindfulness of Breath	Behavioral: 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.
Active Comparator: Cognitive-Behaviorally Based Pain Psychoeducation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
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.	Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Change in Postoperative Opioid Use	Single-item, dichotomously scored (no vs. yes): "Did you take opioid medications in the last 24 hours?"	Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-Transcendent State	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.	Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
Patient Confidence	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.	Completed immediately after the preoperative intervention
Patient Intent	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.	Completed immediately after the preoperative 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): October 29, 2019
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): August 13, 2020

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Acute Pain
• Other Study ID Numbers: IRB_00123611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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