Clinical trial NCT03308071: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Narcotic use
timeFrame: Index hospitalization for total knee replacement, average 2-3 days
Secondary outcomes:
measure: Narcotic prescriptions
timeFrame: 1 month before, and 3 months and 1 year after joint replacement
measure: Narcotic-associated side effects
timeFrame: Index hospitalization for total knee replacement, average 2-3 days
measure: UCLA activity scores
timeFrame: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
measure: KOOS Jr Survey
timeFrame: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
measure: VR-12 Survey
timeFrame: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
measure: Knee Society Score
timeFrame: At the pre-op visit with the surgeon and 12 weeks post-op
measure: Number of days hospitalized
timeFrame: Reported once , after patient is discharged (1 day)
measure: Satisfaction with hypnosis survey
timeFrame: Pre-op and 2 weeks post-op
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University/Stanford Healthcare
state: California
Study officials:
References:
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.