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Clinical Trials/NCT03665727
NCT03665727
Completed
N/A

Psychosocial Support for Pre-operative Pain and Distress

University of Utah1 site in 1 country727 target enrollmentJune 4, 2018
ConditionsAcute Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Pain
Sponsor
University of Utah
Enrollment
727
Locations
1
Primary Endpoint
Pain Unpleasantness Numeric Rating Scale
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients. This study will examine the differential effects of brief mindfulness training, hypnostic suggestion, and cognitive behavioral pain psychoeducation for pre-operative patients, with a supplemental nonrandomized usual care comparison group.

Registry
clinicaltrials.gov
Start Date
June 4, 2018
End Date
September 23, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric Garland

Associate Dean for Research College of Social Work Director; Center on Mindfulness and Integrative Health Intervention Development (C-MIIND)

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 the Joint Replacement 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

Pain Unpleasantness Numeric Rating Scale

Time Frame: Immediately prior to and following intervention

Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.

Pain Intensity Numeric Rating Scale

Time Frame: Immediately prior to and following intervention

Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.

Secondary Outcomes

  • Sensation Manikin Body Sensation Report(Immediately prior to and following intervention)
  • Pain Medication Desire Numeric Rating Scale(Immediately prior to and following intervention)
  • Anxiety Numeric Rating Scale(Immediately prior to and following intervention)
  • Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0(During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment.)
  • Nondual Awareness Dimensional Assessment - State(Immediately prior to and following intervention)

Study Sites (1)

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