Hypnosis for Symptom Management in Elective Orthopedic Surgery

NCT ID: NCT03308071

Last Updated: 2021-08-25

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2020-08-30

Brief Summary

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The purpose of the study is to determine if teaching self-hypnosis techniques to patients prior to knee replacement surgery will decrease their pain medication requirements, pain medication side-effects, length of stay in the hospital, readmission rates, pain, anxiety, physical function, satisfaction scores, and cost of admission.

Detailed Description

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Patients will be recruited by through orthopedic surgery clinics or contacted by after pre-screening via chart review and given an information brochure. If they are interested in the trial will be emailed or given a paper copy of the consent form and scheduled for a single additional visit in the Integrative Medicine Center at Hoover Pavilion approximately 1 week before surgery. At the single study visit, participants would be consented, then a mini-mental state test would be performed to determine if participants are eligible by a score of 25 or above. If eligible, participants would be asked to fill out surveys relating to demographics, attitudes and experience with hypnosis, and detailed pain medication usage. Then, participants would be randomized to hypnosis vs. no hypnosis. The hypnosis group will undergo a Hypnotic Induction Profile to score hypnotizability, then be lead through a hypnosis induction and read a perioperative symptom management script, then re-alerted from hypnosis. Patients in this group would then be asked to listen to the same hypnosis script on a telephone recording twice per day until after the surgery when participants feel they don't need it anymore.

The control group will fill out the surveys and the study visit will end. Participants will be asked not to use any hypnosis until the trial period is over. Data regarding pain, activity, and satisfaction is already collected by email survey or by Ipad in orthopedic clinic at or before the pre-op visit, and 3 months post-op.

Patients in the knee study will be asked to fill out the same surveys around the two week and six week post-op orthopedic clinic visits as well. One additional survey will be added at the 2 week post-op visit to reassess attitudes and experience with hypnosis, and detailed pain medication usage. Those participants who do not fill out the survey will be called and/or emailed to remind them to fill it out.

Conditions

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Hypnosis Perioperative Care Knee Arthroplasty, Total Postoperative Pain Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
The treating team including surgeons, anesthesiologists, pain consultants, hospitalists who are in charge of administering pain medication and documenting outcomes will be blinded to the intervention.

Study Groups

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Hypnosis Group

Participants will undergo a brief hypnotic assessment, a single hypnosis session with an MD trained in hypnosis, and be given a phone number to listen to a guided self-hypnosis recording for 1 week pre-op until 2 weeks post-op.

Group Type EXPERIMENTAL

Hypnosis

Intervention Type BEHAVIORAL

Hypnotic induction, relaxation, and guided imagery specific to perioperative symptoms will be administered.

Usual care

These patients will be enrolled in the study and usual care will be provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hypnosis

Hypnotic induction, relaxation, and guided imagery specific to perioperative symptoms will be administered.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old.
* scheduled for a primary, unilateral, total knee replacement surgery within the study period
* able to commit to a single study clinic visit at least one week prior to their scheduled surgery and use of phone recordings
* able to read and understand English
* Score at least 25 on mini-mental state exam

Exclusion Criteria

* severe psychiatric or structural brain disease (ie. psychosis, stroke with functional impairment, dementia)
* current use of hypnosis/self-hypnosis
* enrolled in other clinical trials related to pain management or length of stay
* hearing impairment that would impede ability to listen to a phone recording
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jessie Kittle

Clinical Instructor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University/Stanford Healthcare

Palo Alto, California, United States

Site Status

Countries

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United States

References

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Markovits J, Blaha O, Zhao E, Spiegel D. Effects of hypnosis versus enhanced standard of care on postoperative opioid use after total knee arthroplasty: the HYPNO-TKA randomized clinical trial. Reg Anesth Pain Med. 2022 Jun 17:rapm-2022-103493. doi: 10.1136/rapm-2022-103493. Online ahead of print.

Reference Type DERIVED
PMID: 35715013 (View on PubMed)

Other Identifiers

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IRB-41122

Identifier Type: -

Identifier Source: org_study_id

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