Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

Pain Clinical Trial

Official title:

Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04520958
• Other study ID #: IRB_00123611
• Status: Completed
• Phase: N/A
• Start date: October 29, 2019
• Est. completion date: August 13, 2020

Study information

• Verified date: October 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: August 13, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Arthralgia
• Pain
• Pain, Acute
• Pain, Joint

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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
Other	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
Primary	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)
Primary	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	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.
Secondary	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.