Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

Conditions
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Anxiety, Opioid Use

Intervention / Treatment
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* Behavioral: Hypnosis Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis Therapy Group<br>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<br>* 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.<br>* Other names: Hypnotherapy;|
| No Intervention: Control Care Group<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Hypnosis, Total Knee