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Completed

NCT Number: NCT04520958

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.

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Key information

Conditions

Pain, Acute Acute Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Joint Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness of Breath

Behavioral

Mindfulness of Breath consisted of instruction in focused attention on the breath and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.

Mindfulness of Pain

Behavioral

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.

Cognitive-Behaviorally Based Pain Psychoeducation

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 20, 2020
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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