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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnosis Therapy Group | Experimental | 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. |
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| Control Care Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnosis Therapy | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian T Palumbo, MD | Florida Orthopaedic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Orthopaedic Institute | Tampa | Florida | 33637 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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|
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 |
| D004191 |
| Behavioral Disciplines and Activities |