Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy

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 Overview

• Status: Completed
• Conditions: Anxiety; Opioid Use
• Intervention / Treatment: Behavioral: hypnosis therapy

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaitlyn N Christmas, BS, CCRC; Phone Number: 6822 813-978-9700; Email: kchristmas@foreonline.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33637
      • Florida Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnosis Therapy Group; 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.	Behavioral: hypnosis 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.; Other Names: hypnotherapy
No Intervention: Usual Care Group; Patients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, & shoulder function. 7 days before surgery, they will receive a daily questionnaire about their pain & anxiety over the last 24 hours. On the day of surgery, before they are given any anesthesia, they will answer questions about their average anxiety & pain levels. Starting the next morning on the day following surgery and every day for the subsequent week, they will be given questionnaires about their pain & anxiety levels, medication use, satisfaction, and sleep disturbance due to pain. Their postoperative course will be otherwise completely standard of care, including a first postoperative clinic visit at 10 days after surgery, where the patients will be given these same questionnaires. Finally, patients will answer them one more time on postoperative day 49 and this will constitute a study endpoint. The whole process each day should take approximately 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perioperative Anxiety	Patient-reported anxiety in the perioperative period	7 days before surgery, day of surgery, 7 days after surgery
Change in Perioperative Pain	Patient-reported pain in the perioperative period	7 days before surgery, day of surgery, 7 days after surgery
Change in Opioid Consumption	Patient-reported opioid consumption in the perioperative period	7 days after surgery, postoperative day 10, postoperative day 49

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiolytic Consumption	Patient-reported opioid consumption in the perioperative period	7 days after surgery, postoperative day 10, postoperative day 49

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education
• Investigators: Principal Investigator: Mark A Frankle, MD, Florida Orthopaedic Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2020
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: hypnosis; shoulder arthroplasty
• Other Study ID Numbers: 1.0 - 20203698

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No