Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Opioid Use
• Intervention / Treatment: Behavioral: Hypnosis Therapy

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33637
      • Florida Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnosis Therapy Group; 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.	Behavioral: Hypnosis Therapy; Pre-recorded hypnosis therapy audio recording with accompanying visual of a calming ocean scene to be played at least once daily for 7 days preoperatively.; Other Names: Hypnotherapy
No Intervention: Control Care Group; No Intervention: Control Care 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 information 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perioperative Pain - Knee Society Score/ Knee Injury and Osteoarthritis Scores	Patient-reported pain in the perioperative period	7 days prior to surgery, 10 days postoperative day, 49 days postoperative day
Change in Opioid Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client	Change in Anxiolytic Consumption	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	Change in Anxiolytic Consumption	7 days prior to surgery, 10 days postoperative day, 49 days postoperative day

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education
• Investigators: Principal Investigator: Brian T Palumbo, MD, Florida Orthopaedic Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Hypnosis; Total Knee Arthroplasty; Total Knee
• Other Study ID Numbers: 2.0 - 20203698

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No