Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

Foundation for Orthopaedic Research and Education

Status: Completed

Conditions: Opioid Use; Anxiety

Treatments: Behavioral: Hypnosis Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05818969

2.0 - 20203698

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 2 patient groups

Hypnosis Therapy Group

Experimental group

Description:

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.

Treatment:

Behavioral: Hypnosis Therapy

Control Care Group

No Intervention group

Description:

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.