Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Anxiety Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hypnosis Therapy Group

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.

Group Type EXPERIMENTAL

Hypnosis Therapy

Intervention Type 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.

Control Care Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Hypnotherapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes