Anxiety, Opioid Use
Conditions
Keywords
Hypnosis, Total Knee Arthroplasty, Total Knee
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.
Interventions
BEHAVIORALHypnosis 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.
Sponsors
Foundation for Orthopaedic Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed