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Hypnosis for Symptom Management in Elective Orthopedic Surgery

Primary Purpose

Hypnosis, Perioperative Care, Knee Arthroplasty, Total

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypnosis
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypnosis focused on measuring Hypnosis, Hypnotherapy, Perioperative Pain Management, Narcotic reduction, Perioperative Outcomes, Total knee replacement, Total knee arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University/Stanford Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hypnosis Group

Usual care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Narcotic use
Total narcotic use during the hospital stay will be calculated in "morphine equivalents"

Secondary Outcome Measures

Narcotic prescriptions
Total narcotics prescribed in the outpatient setting
Narcotic-associated side effects
Incidence of delirium, constipation, urinary retention, respiratory depression
UCLA activity scores
Classifies the activity level of joint replacement patients
KOOS Jr Survey
Knee injury and osteoarthritis outcome score
VR-12 Survey
Measures health-related quality of life
Knee Society Score
Prosthesis function and patients' functional abilities after total knee arthroplasty (TKA)
Number of days hospitalized
Total number of days hospitalized for total knee replacement surgery
Satisfaction with hypnosis survey
Attitudes and expectations regarding hypnosis

Full Information

First Posted
June 23, 2017
Last Updated
August 23, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03308071
Brief Title
Hypnosis for Symptom Management in Elective Orthopedic Surgery
Official Title
A Randomized Study Using Hypnosis for Symptom Management in Elective Orthopedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypnosis, Perioperative Care, Knee Arthroplasty, Total, Postoperative Pain, Postoperative Complications
Keywords
Hypnosis, Hypnotherapy, Perioperative Pain Management, Narcotic reduction, Perioperative Outcomes, Total knee replacement, Total knee arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
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.
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
These patients will be enrolled in the study and usual care will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
Hypnotic induction, relaxation, and guided imagery specific to perioperative symptoms will be administered.
Primary Outcome Measure Information:
Title
Narcotic use
Description
Total narcotic use during the hospital stay will be calculated in "morphine equivalents"
Time Frame
Index hospitalization for total knee replacement, average 2-3 days
Secondary Outcome Measure Information:
Title
Narcotic prescriptions
Description
Total narcotics prescribed in the outpatient setting
Time Frame
1 month before, and 3 months and 1 year after joint replacement
Title
Narcotic-associated side effects
Description
Incidence of delirium, constipation, urinary retention, respiratory depression
Time Frame
Index hospitalization for total knee replacement, average 2-3 days
Title
UCLA activity scores
Description
Classifies the activity level of joint replacement patients
Time Frame
At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
Title
KOOS Jr Survey
Description
Knee injury and osteoarthritis outcome score
Time Frame
At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
Title
VR-12 Survey
Description
Measures health-related quality of life
Time Frame
At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
Title
Knee Society Score
Description
Prosthesis function and patients' functional abilities after total knee arthroplasty (TKA)
Time Frame
At the pre-op visit with the surgeon and 12 weeks post-op
Title
Number of days hospitalized
Description
Total number of days hospitalized for total knee replacement surgery
Time Frame
Reported once , after patient is discharged (1 day)
Title
Satisfaction with hypnosis survey
Description
Attitudes and expectations regarding hypnosis
Time Frame
Pre-op and 2 weeks post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University/Stanford Healthcare
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35715013
Citation
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.
Results Reference
derived

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Hypnosis for Symptom Management in Elective Orthopedic Surgery

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