Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

Foundation for Orthopaedic Research and Education1 site in 1 country73 target enrollmentFebruary 1, 2022

ConditionsAnxiety Opioid Use

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety
Sponsor: Foundation for Orthopaedic Research and Education
Enrollment: 73
Locations: 1
Primary Endpoint: Change in Perioperative Anxiety - Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to collect information to evaluate the role of the psychogenic component of pain induced by anxiety on postoperative outcomes in major orthopaedic surgery and to determine whether hypnosis therapy provided during the perioperative period will lead to decreased use of opioid therapy. Patients are randomly assigned to one of two treatment groups: (I) usual care, or; (II) hypnotherapy treatment. Patients have an equal chance of being assigned to one of the two groups.

Registry

clinicaltrials.gov

Start Date

February 1, 2022

End Date

December 31, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Foundation for Orthopaedic Research and Education

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of primary knee arthritis, in need of a total knee arthroplasty.
•The ability to read, speak, and understand English
•The ability and willingness to use a web-based application (OBERD) on a smartphone, pad/tablet, or computer
•18 years of age or older

Exclusion Criteria

•Revision total knee arthroplasty
•Any knee procedure except a primary knee arthroplasty, since these procedures have shown to result on increased postoperative pain compared to primary surgery
•Patients with active cancer or receiving palliative care

Outcomes

Primary Outcomes

Change in Perioperative Anxiety - Amsterdam Preoperative Anxiety and Information Scale (APAIS)

Time Frame: 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day

Patient-reported anxiety in the perioperative period

Secondary Outcomes

Change in Opioid Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client(7 days prior to surgery, 10 days postoperative day, 49 days postoperative day)
Change in Anxiolytic Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client(7 days prior to surgery, 10 days postoperative day, 49 days postoperative day)
Change in Perioperative Pain - Knee Society Score/ Knee Injury and Osteoarthritis Scores(7 days prior to surgery, 10 days postoperative day, 49 days postoperative day)