Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

Not Applicable

Completed

• Conditions: Pain; Pain, Acute; Pain, Joint
• Interventions: Behavioral: Mindfulness of Breath; Behavioral: Mindfulness of Pain; Behavioral: Cognitive-Behaviorally Based Pain Psychoeducation

• Registration Number: NCT04520958
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10-29
• Primary Completion: 2020-03-10
• Study Completion: 2020-08-13
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness of Breath	Mindfulness of Breath	-
Mindfulness of Pain	Mindfulness of Pain	-
Cognitive-Behaviorally Based Pain Psychoeducation	Cognitive-Behaviorally Based Pain Psychoeducation	-

Primary Outcome Measures

Name	Time	Method
Change in Preoperative Pain Intensity	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.
Change in Postoperative Pain Intensity	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

Name	Time	Method
Change in Postoperative Pain Unpleasantness	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.
Change in Postoperative Opioid Use	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?"

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States