Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy

Foundation for Orthopaedic Research and Education144 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

144

Conditions

Anxiety Opioid Use

Interventions

hypnosis therapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Florida Orthopaedic Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

Change in Perioperative Anxiety

Patient-reported anxiety in the perioperative period

Time frame: 7 days before surgery, day of surgery, 7 days after surgery

Change in Perioperative Pain

Patient-reported pain in the perioperative period

Time frame: 7 days before surgery, day of surgery, 7 days after surgery

Change in Opioid Consumption

Patient-reported opioid consumption in the perioperative period

Time frame: 7 days after surgery, postoperative day 10, postoperative day 49

Secondary Outcomes

Change in Anxiolytic Consumption

Patient-reported opioid consumption in the perioperative period

Time frame: 7 days after surgery, postoperative day 10, postoperative day 49

Data from ClinicalTrials.gov

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