December 06, 2023
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
Christopher J. Li, MD
Michael Ast, MD
Brian Chalmers, MD
Stephanie Cheng, MD
Eytan M. Debbi, MD, PhD
Elizabeth B. Gausden, MD, MPH
Alex Illescas
Cynthia A. Kahlenberg, MD, MPH
Justas Lauzadis
Marko Popovic
Angela Puglisi
Miriam Sheetz,
Maya Tailor
Pa Thor
Haoyan Zhong
Mindfulness meditation is a practice well-known to psychology research
based on sustained attention on the present and a non-judgment of one's
current situation. This intervention group will be compared against a
waitlist control group (patients will be told they are on a waitlist to receive
the mindfulness intervention, which will occur after data collection has
finished for their group). Measures of anxiety, depression, resilience, pain
catastrophizing, pain and pain unpleasantness, and overall physical and
mental health will be taken after randomization, but before the
intervention (or being told they are on the waitlist). We will enroll 30
patients and anticipate enrollment to last from January 2024 to April 2024.
The waitlist control group will receive the MMI at 90 days post-surgery
and will receive their last follow up 2 weeks after that. The intervention
group will receive the MMI on their day of surgery and their last follow up
will be 90 days post-surgery.
Inclusion criteria:
i. Adult patients undergoing primary total knee arthroplasty with a participating surgeon.
ii. Patients on these medications for depression/anxiety: Fluoxetine, Paroxetine, Citalopram, Escitalopram, Escitalopram, Sertraline,
Fluvoxamine, Venlafaxine, Duloxetine, Levomilnacipran, Desvenlafaxine, Bupropion, Mirtazapine, Amitriptyline, Nortriptyline, Clonazepam, Alprazolam, Lorazepam, Diazepam, Oxazepam, Chlordiazepoxide
iii. Patients receiving intraoperative auricular acupuncture as part of participating surgeon’s preferred anesthetic care
iv. Patients fluent in English
v. ASA I-II
vi. BMI < 40
Exclusion criteria:
i. Patient not fluent in English (inability to understand the intervention video will likely affect ability to utilize the mindfulness techniques taught)
ii. Pediatric patients < 18 years of age
iii. Patients with contraindications to intra-op protocol
iv. Patients with contraindications to auricular acupuncture (non-native ear, active ear infection, gauges in the ears)
v. Patients unable/unwilling to participate in the questionnaires or listen to the scripted intervention.
vi. Patients scheduled for consecutive or staged surgeries.
vii. Patients allergic to local anesthetics or study medications
viii. Patients who have kidney disease
Angela Puglisi
puglisia@hss.edu
646.714.6849
Christopher J. Li, MD
lich@hss.edu
212.606.1206