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Completed

NCT Number: NCT04889833

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Opioid Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypnosis therapy

Behavioral

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

Primary outcomes

  1. Change in Perioperative Anxiety

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

    Patient-reported anxiety in the perioperative period

  2. Change in Perioperative Pain

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

    Patient-reported pain in the perioperative period

  3. 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

  1. Change in Anxiolytic Consumption

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

    Patient-reported opioid consumption in the perioperative period

Sponsors and collaborators

Lead sponsor

Foundation for Orthopaedic Research and Education

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 17, 2021
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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