Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

Sponsor

Foundation for Orthopaedic Research and Education (Other)

Overall Status

Recruiting

CT.gov ID

NCT05818969

Collaborator

(none)

144

Enrollment

Location

Arms

22.9

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Opioid Use	Behavioral: Hypnosis Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Orthopaedic Institute	Tampa	Florida	United States	33637

Sponsors and Collaborators

Foundation for Orthopaedic Research and Education

Investigators

Principal Investigator: Brian T Palumbo, MD, Florida Orthopaedic Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Foundation for Orthopaedic Research and Education

ClinicalTrials.gov Identifier:

NCT05818969

Other Study ID Numbers:

2.0 - 20203698

First Posted:

Apr 19, 2023

Last Update Posted:

Apr 19, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Foundation for Orthopaedic Research and Education

Hypnosis

Total Knee Arthroplasty

Total Knee

Study Results

No Results Posted as of Apr 19, 2023