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Hypnosis for Symptom Management in Elective Orthopedic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03308071
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Jessie Kittle, 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.

Condition or disease Intervention/treatment Phase
Hypnosis Perioperative Care Knee Arthroplasty, Total Postoperative Pain Postoperative Complications Behavioral: Hypnosis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Treatment
Official Title: A Randomized Study Using Hypnosis for Symptom Management in Elective Orthopedic Surgery
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

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.



Primary Outcome Measures :
  1. Narcotic use [ Time Frame: 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 :
  1. Narcotic prescriptions [ Time Frame: 1 month before, and 3 months and 1 year after joint replacement ]
    Total narcotics prescribed in the outpatient setting

  2. Narcotic-associated side effects [ Time Frame: Index hospitalization for total knee replacement, average 2-3 days ]
    Incidence of delirium, constipation, urinary retention, respiratory depression

  3. UCLA activity scores [ Time Frame: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op ]
    Classifies the activity level of joint replacement patients

  4. KOOS Jr Survey [ Time Frame: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op ]
    Knee injury and osteoarthritis outcome score

  5. VR-12 Survey [ Time Frame: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op ]
    Measures health-related quality of life

  6. Knee Society Score [ Time Frame: At the pre-op visit with the surgeon and 12 weeks post-op ]
    Prosthesis function and patients' functional abilities after total knee arthroplasty (TKA)

  7. Number of days hospitalized [ Time Frame: Reported once , after patient is discharged (1 day) ]
    Total number of days hospitalized for total knee replacement surgery

  8. Satisfaction with hypnosis survey [ Time Frame: Pre-op and 2 weeks post-op ]
    Attitudes and expectations regarding hypnosis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308071


Contacts
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Contact: Jessie Kittle, MD 8318400599 jkittle@stanford.edu

Locations
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United States, California
Stanford University/Stanford Healthcare Recruiting
Palo Alto, California, United States, 94305
Contact: Jessie Kittle, MD    831-840-0599    jkittle@stanford.edu   
Sponsors and Collaborators
Stanford University
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Responsible Party: Jessie Kittle, Clinical Instructor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03308071    
Other Study ID Numbers: IRB-41122
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessie Kittle, Stanford University:
Hypnosis
Hypnotherapy
Perioperative Pain Management
Narcotic reduction
Perioperative Outcomes
Total knee replacement
Total knee arthroplasty
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes