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Clinical Trials/NCT04520958
NCT04520958
Completed
N/A

Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

University of Utah1 site in 1 country118 target enrollmentOctober 29, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
University of Utah
Enrollment
118
Locations
1
Primary Endpoint
Change in Preoperative Pain Intensity
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 29, 2019
End Date
August 13, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adam Hanley

Assistant Professor

University of Utah

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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

  • Change in Postoperative Pain Unpleasantness(Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.)
  • Change in Postoperative Opioid Use(Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.)

Study Sites (1)

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