Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

• ClinicalTrials.gov Identifier: NCT04520958
• Recruitment Status: Completed
• First Posted: August 20, 2020
• Last Update Posted: August 27, 2020
• Sponsor: University of Utah
• Information provided by (Responsible Party): Adam Hanley, University of Utah

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.

Condition or disease	Intervention/treatment	Phase
Pain, Acute; Pain, Joint; Pain	Behavioral: Mindfulness of Breath; Behavioral: Mindfulness of Pain; Behavioral: Cognitive-Behaviorally Based Pain Psychoeducation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy
• Actual Study Start Date: October 29, 2019
• Actual Primary Completion Date: March 10, 2020
• Actual Study Completion Date: August 13, 2020

Arms and Interventions

Arm	Intervention/treatment
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.
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Change in Preoperative Pain Intensity [ Time Frame: Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes) ]
   Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
2. Change in Postoperative Pain Intensity [ Time Frame: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days. ]
   Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.

Secondary Outcome Measures :

1. Change in Postoperative Pain Unpleasantness [ Time Frame: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days. ]
   Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
2. Change in Postoperative Opioid Use [ Time Frame: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days. ]
   Single-item, dichotomously scored (no vs. yes): "Did you take opioid medications in the last 24 hours?"

Other Outcome Measures:

1. Change in Self-Transcendent State [ Time Frame: Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes) ]
   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.
2. Patient Confidence [ Time Frame: Completed immediately after the preoperative intervention ]
   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.
3. Patient Intent [ Time Frame: Completed immediately after the preoperative intervention ]
   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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

University of Utah

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Adam Hanley, Assistant Professor, University of Utah
• ClinicalTrials.gov Identifier: NCT04520958
• Other Study ID Numbers: IRB_00123611
• First Posted: August 20, 2020
• Last Update Posted: August 27, 2020
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Arthralgia; Acute Pain; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases