An interventional study of Mindfulness of Breath and Mindfulness of Pain in Pain, Acute, Pain, Joint and Pain, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-27.
Sponsored by University of Utah · Not applicable, Interventional, and Prevention
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.
273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.
This study's enrollment of 118 is above the median of 63 across 219 interventional studies indexed under Arthralgia.
Browse Arthralgia studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Exclusion Criteria:
Behavioral: Mindfulness of Breath
Behavioral: Mindfulness of Pain
Behavioral: Cognitive-Behaviorally Based Pain Psychoeducation
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 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 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.
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.
Time frame: 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.
Time frame: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
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.
Time frame: 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?"
Time frame: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
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.
Time frame: 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.
Time frame: 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.
Time frame: Completed immediately after the preoperative intervention
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University of Utah