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Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04520958
Enrollment
118
Registered
2020-08-20
Start date
2019-10-29
Completion date
2020-08-13
Last updated
2020-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute, Pain, Joint, Pain

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.

Interventions

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.

BEHAVIORALCognitive-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.

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Preoperative Pain IntensityCompleted 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.
Change in Postoperative Pain IntensityCompleted 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

MeasureTime frameDescription
Change in Postoperative Pain UnpleasantnessCompleted 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.
Change in Postoperative Opioid UseCompleted 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

MeasureTime frameDescription
Patient ConfidenceCompleted immediately after the preoperative interventionPatients' 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.
Patient IntentCompleted immediately after the preoperative interventionPatients' 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.
Change in Self-Transcendent StateCompleted 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026