Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

NCT05818969 | Completed

• 1 other identifier: 2.0 - 20203698
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Opioid Use

Keywords

Hypnosis; Total Knee Arthroplasty; Total Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  7 days prior to surgery, 10 days postoperative day, 49 days postoperative day

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

  7 days prior to surgery, 10 days postoperative day, 49 days postoperative day

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

  7 days prior to surgery, 10 days postoperative day, 49 days postoperative day

Study Arms (2)

Hypnosis Therapy Group

EXPERIMENTAL

Experimental: Hypnosis Therapy Group Patients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, \& knee function. 7 days prior to surgery, they will receive a pre-recorded video (-19 min) of guided hypnosis to be watched at least 1x/day, until surgery. 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 total knee arthroplasty regardless of study participation.

Behavioral: Hypnosis Therapy

Control Care Group

NO INTERVENTION

No Intervention: Control Care Group Patients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, \& knee function. 7 days prior to surgery, they will receive a pre-recorded video (-19 min) of guided information to be watched at least 1x/day, until surgery. 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 total knee arthroplasty regardless of study participation.

Interventions

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.

Also known as: Hypnotherapy

Hypnosis Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation for Orthopaedic Research and Education: lead

Study Sites (1)

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Brian T Palumbo, MD

  Florida Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 19, 2023
• Study Start: February 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)