Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

Not Applicable

Completed

• Conditions: Anxiety; Opioid Use
• Interventions: Behavioral: Hypnosis Therapy

• Registration Number: NCT05818969
• Lead Sponsor: Foundation for Orthopaedic Research and Education

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-19
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis Therapy Group	Hypnosis Therapy	Experimental: Hypnosis Therapy Group Patients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, \& knee function. 7 days prior to surgery, they will receive a pre-recorded video (-19 min) of guided hypnosis to be watched at least 1x/day, until surgery. Postoperative course will be otherwise completely standard of care, including a clinic visit at 10 days after surgery, where they will be given these same questionnaires. Patients will answer them again on postoperative day 49, constituting a study endpoint. Access to pain medication \& study doctor will be the same as any total knee arthroplasty regardless of study participation.

Primary Outcome Measures

Name	Time	Method
Change in Perioperative Anxiety - Amsterdam Preoperative Anxiety and Information Scale (APAIS)	7 days prior to surgery, 10 days postoperative day, 49 days postoperative day	Patient-reported anxiety in the perioperative period

Secondary Outcome Measures

Name	Time	Method
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
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 Anxiolytic Consumption
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	Patient-reported pain in the perioperative period

Trial Locations

Locations (1)

Florida Orthopaedic Institute; 🇺🇸 Tampa, Florida, United States