Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy

Not Applicable

Completed

• Conditions: Opioid Use; Anxiety
• Interventions: Behavioral: hypnosis therapy

• Registration Number: NCT04889833
• Lead Sponsor: Foundation for Orthopaedic Research and Education

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-19
• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-17
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis Therapy Group	hypnosis therapy	Patients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, \& shoulder function. 7 days before surgery, they will receive a pre-recorded video (\~19 min) of guided hypnosis to be watched at least 1x/day, until surgery. Before \& after the video, they will rate pain/anxiety levels. On the day of surgery, they will watch the video again \& answer questions about their average anxiety and pain level. After surgery, they will watch the video each day and report on pain/anxiety, medication use, satisfaction, and sleep disturbance until postoperative day 7. 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 shoulder arthroplasty patient regardless of study participation.

Primary Outcome Measures

Name	Time	Method
Change in Perioperative Pain	7 days before surgery, day of surgery, 7 days after surgery	Patient-reported pain in the perioperative period
Change in Perioperative Anxiety	7 days before surgery, day of surgery, 7 days after surgery	Patient-reported anxiety 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 Outcome Measures

Name	Time	Method
Change in Anxiolytic Consumption	7 days after surgery, postoperative day 10, postoperative day 49	Patient-reported opioid consumption in the perioperative period

Trial Locations

Locations (1)

Florida Orthopaedic Institute; 🇺🇸 Tampa, Florida, United States