Hypnosis for Symptom Management in Elective Orthopedic Surgery

A Randomized Study Using Hypnosis for Symptom Management in Elective Orthopedic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Pain; Hypnosis; Perioperative Care; Knee Arthroplasty, Total
• Intervention / Treatment: Behavioral: Hypnosis

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University/Stanford Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Hypnosis; Hypnotic induction, relaxation, and guided imagery specific to perioperative symptoms will be administered.
No Intervention: Usual care; These patients will be enrolled in the study and usual care will be provided.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• 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. pii: rapm-2022-103493. doi: 10.1136/rapm-2022-103493. [Epub ahead of print]

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Hypnosis; Total knee replacement; Hypnotherapy; Perioperative Pain Management; Narcotic reduction; Perioperative Outcomes; Total knee arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: IRB-41122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No