Hypnosis for Symptom Management in Elective Orthopedic Surgery
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|ClinicalTrials.gov Identifier: NCT03308071|
Recruitment Status : Completed
First Posted : October 12, 2017
Last Update Posted : August 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hypnosis Perioperative Care Knee Arthroplasty, Total Postoperative Pain Postoperative Complications||Behavioral: Hypnosis||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||64 participants|
|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.|
|Official Title:||A Randomized Study Using Hypnosis for Symptom Management in Elective Orthopedic Surgery|
|Actual Study Start Date :||September 20, 2017|
|Actual Primary Completion Date :||August 30, 2019|
|Actual Study Completion Date :||August 30, 2020|
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.
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.
- 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"
- Narcotic prescriptions [ Time Frame: 1 month before, and 3 months and 1 year after joint replacement ]Total narcotics prescribed in the outpatient setting
- Narcotic-associated side effects [ Time Frame: Index hospitalization for total knee replacement, average 2-3 days ]Incidence of delirium, constipation, urinary retention, respiratory depression
- 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
- 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
- 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
- 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)
- Number of days hospitalized [ Time Frame: Reported once , after patient is discharged (1 day) ]Total number of days hospitalized for total knee replacement surgery
- Satisfaction with hypnosis survey [ Time Frame: Pre-op and 2 weeks post-op ]Attitudes and expectations regarding hypnosis
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
|United States, California|
|Stanford University/Stanford Healthcare|
|Palo Alto, California, United States, 94305|