Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety
- Sponsor
- Foundation for Orthopaedic Research and Education
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Change in Perioperative Pain
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in Perioperative Pain
Time Frame: 7 days before surgery, day of surgery, 7 days after surgery
Patient-reported pain in the perioperative period
Change in Perioperative Anxiety
Time Frame: 7 days before surgery, day of surgery, 7 days after surgery
Patient-reported anxiety in the perioperative period
Change in Opioid Consumption
Time Frame: 7 days after surgery, postoperative day 10, postoperative day 49
Patient-reported opioid consumption in the perioperative period
Secondary Outcomes
- Change in Anxiolytic Consumption(7 days after surgery, postoperative day 10, postoperative day 49)