Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

Anxiety Clinical Trial

Official title:

Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05818969
• Other study ID #: 2.0 - 20203698
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 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: 73
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Opioid Use

Intervention

Behavioral:
• Hypnosis Therapy
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.

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 - Amsterdam Preoperative Anxiety and Information Scale (APAIS)	Patient-reported anxiety in the perioperative period	7 days prior to surgery, 10 days postoperative day, 49 days postoperative day
Secondary	Change in Perioperative Pain - Knee Society Score/ Knee Injury and Osteoarthritis Scores	Patient-reported pain in the perioperative period	7 days prior to surgery, 10 days postoperative day, 49 days postoperative day
Secondary	Change in Opioid Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client	Change in Anxiolytic Consumption	7 days prior to surgery, 10 days postoperative day, 49 days postoperative day
Secondary	Change in Anxiolytic Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client	Change in Anxiolytic Consumption	7 days prior to surgery, 10 days postoperative day, 49 days postoperative day