Anxiety, Opioid Use
Conditions
Keywords
hypnosis, shoulder arthroplasty
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 calm ocean to be played at least once daily for 7 preoperative days, the day of surgery, and for 7 days postoperatively.
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 shoulder osteoarthritis, massive cuff tear arthropathy, and rotator cuff arthropathy requiring a primary total or reverse shoulder replacement, * the ability to read, speak, and understand English * the ability and willingness to use a web-based application (OBERD) on a smartphone, pad, or computer, and * 18 years of age or older.
Exclusion criteria
* shoulder replacement for the treatment of acute proximal humerus fractures * hemiarthroplasty * revision shoulder replacement * patients with active cancer or receiving palliative care * Less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perioperative Anxiety | 7 days before surgery, day of surgery, 7 days after surgery | Patient-reported anxiety in the perioperative period |
| Change in Perioperative Pain | 7 days before surgery, day of surgery, 7 days after surgery | Patient-reported pain in the perioperative period |
| Change in Opioid Consumption | 7 days after surgery, postoperative day 10, postoperative day 49 | Patient-reported opioid consumption in the perioperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiolytic Consumption | 7 days after surgery, postoperative day 10, postoperative day 49 | Patient-reported opioid consumption in the perioperative period |
Countries
United States
Outcome results
None listed