Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy

Anxiety Clinical Trial

Official title:

Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889833
• Other study ID #: 1.0 - 20203698
• Status: Completed
• Phase: N/A
• Start date: December 19, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2024
• Source: Foundation for Orthopaedic Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Opioid Use

Intervention

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.

Locations

Country	Name	City	State
United States	Florida Orthopaedic Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Orthopaedic Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Perioperative Anxiety	Patient-reported anxiety in the perioperative period	7 days before surgery, day of surgery, 7 days after surgery
Primary	Change in Perioperative Pain	Patient-reported pain in the perioperative period	7 days before surgery, day of surgery, 7 days after surgery
Primary	Change in Opioid Consumption	Patient-reported opioid consumption in the perioperative period	7 days after surgery, postoperative day 10, postoperative day 49
Secondary	Change in Anxiolytic Consumption	Patient-reported opioid consumption in the perioperative period	7 days after surgery, postoperative day 10, postoperative day 49