Hypnosis for Symptom Management in Elective Orthopedic Surgery

Not Applicable

Completed

• Conditions: Knee Arthroplasty, Total; Postoperative Complications; Hypnosis; Perioperative Care; Postoperative Pain
• Interventions: Behavioral: Hypnosis

• Registration Number: NCT03308071
• Lead Sponsor: Stanford University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-06-23
• Study Start: 2017-09-20
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-12
• Primary Completion: 2019-08-30
• Study Completion: 2020-08-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis Group	Hypnosis	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.

Primary Outcome Measures

Name	Time	Method
Narcotic use	Index hospitalization for total knee replacement, average 2-3 days	Total narcotic use during the hospital stay will be calculated in "morphine equivalents"

Secondary Outcome Measures

Name	Time	Method
Narcotic prescriptions	1 month before, and 3 months and 1 year after joint replacement	Total narcotics prescribed in the outpatient setting
Narcotic-associated side effects	Index hospitalization for total knee replacement, average 2-3 days	Incidence of delirium, constipation, urinary retention, respiratory depression
UCLA activity scores	At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op	Classifies the activity level of joint replacement patients
KOOS Jr Survey	At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op	Knee injury and osteoarthritis outcome score
VR-12 Survey	At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op	Measures health-related quality of life
Knee Society Score	At the pre-op visit with the surgeon and 12 weeks post-op	Prosthesis function and patients' functional abilities after total knee arthroplasty (TKA)
Number of days hospitalized	Reported once , after patient is discharged (1 day)	Total number of days hospitalized for total knee replacement surgery
Satisfaction with hypnosis survey	Pre-op and 2 weeks post-op	Attitudes and expectations regarding hypnosis

Trial Locations

Locations (1)

Stanford University/Stanford Healthcare; 🇺🇸 Palo Alto, California, United States