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OpenTrials
Completed

NCT Number: NCT05818969

Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

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 knee arthritis, in need of a total knee arthroplasty.
  • The ability to read, speak, and understand English
  • The ability and willingness to use a web-based application (OBERD) on a smartphone, pad/tablet, or computer
  • 18 years of age or older

Exclusion criteria

  • Revision total knee arthroplasty
  • Any knee procedure except a primary knee arthroplasty, since these procedures have shown to result on increased postoperative pain compared to primary surgery
  • Patients with active cancer or receiving palliative care

Treatment and study plan

hypnosis therapy

Behavioral

Pre-recorded hypnosis therapy audio recording with accompanying visual of a calming ocean scene to be played at least once daily for 7 days preoperatively.

Other names: Hypnotherapy

Primary outcomes

  1. Change in Perioperative Anxiety - Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Time frame: 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day

    Patient-reported anxiety in the perioperative period

Secondary outcomes

  1. Change in Perioperative Pain - Knee Society Score/ Knee Injury and Osteoarthritis Scores

    Time frame: 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day

    Patient-reported pain in the perioperative period

  2. Change in Opioid Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client

    Time frame: 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day

    Change in Anxiolytic Consumption

  3. Change in Anxiolytic Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client

    Time frame: 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day

    Change in Anxiolytic Consumption

Sponsors and collaborators

Lead sponsor

Foundation for Orthopaedic Research and Education

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Jun 13, 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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