Preoperative Mindfulness Meditation for Total Knee Arthroplasty: A Pilot Study
Phase: NA
Conditions: Total Knee Replacement, Mediation, Feasibility
Sponsor: Hospital for Special Surgery, New York

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Preoperative Mindfulness Meditation for Total Knee 
Arthroplasty: A Pilot Study 
 
FUNDER: 
Anesthesiology Research Department 
PROTOCOL NO.: 
2023-2131 
VERSION & DATE: 
Version 1, 11/16/23 
 
 
 
 
 
 
 
 
 
 
 
 
This document contains the confidential information of the Hospital for Special Surgery.  It is provided to you and your company’s personnel for 
review.  Your acceptance of this document constitutes an agreement that you will not disclose the information contained herein to others without 
the prior written consent of the Hospital for Special Surgery.  No other use or reproduction is authorized by Hospital for Special Surgery, nor does 
the Hospital for Special Surgery assume any responsibility for unauthorized use of this protocol. 
 

 
Protocol Number: 2023-2131  
Version Date: 11/16/23 
 
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TABLE OF CONTENTS 
TABLE OF CONTENTS................................................................................................................... 2 
PROTOCOL SYNOPSIS.................................................................................................................. 3 
1.0     INTRODUCTION .................................................................................................................... 4 
    2.0 
PRODUCT DESCRIPTION………………………..……………………………………………….4 
3.0      OBJECTIVE OF CLINICAL STUDY ...................................................................................... 4 
4.0      STUDY HYPOTHESIS ........................................................................................................... 4 
5.0      STUDY DESIGN .................................................................................................................... 4 
5.1 
Study Duration ................................................................................................................ 4 
5.2 
Endpoints ....................................................................................................................... 4 
5.2.1 
Primary Endpoint ...................................................................................................... 4 
5.2.2 
Secondary Endpoints ................................................................................................ 4 
5.2.3 
Safety Evaluations. ................................................................................................... 4 
5.3 
Study Site ....................................................................................................................... 4 
6.0        STUDY POPULATION ......................................................................................................... 4 
6.1 
Number of Subjects ........................................................................................................ 4 
6.2 
Inclusion Criteria............................................................................................................. 5 
6.3 
Exclusion Criteria: .......................................................................................................... 5 
    6.4        Randomization………………………………………………………………………………..5 
7.0         PROCEDURES .................................................................................................................... 5 
7.1 
Surgical Procedure ......................................................................................................... 5 
 
7.1.1. Investigational Product Administration………………………………………………. .…..5 
7.2 
Imaging Procedure ......................................................................................................... 5 
7.3 
Medical Record Requirements ....................................................................................... 5 
7.4 
Data Collection ............................................................................................................... 5 
    7.5        Schedule of Assessments……………………………………………………..…………….. 6 
7.6 
Radiological Evaluations ................................................................................................ 7 
7.7 
Clinical Evaluations ........................................................................................................ 7 
 
7.7.1. Revision Surgery………………………………………………………………………. .……7 
8.0         STATISTICAL ANALYSIS .................................................................................................. 7 
9.0         ADVERSE EVENT ASSESSMENT ..................................................................................... 7 
9.1 
Adverse Event (AE) ........................................................................................................ 7 
9.2 
Serious Adverse Events (SAE) ...................................................................................... 7 
9.3 
Subsequent Surgical Interventions Definitions .............................................................. 7 
9.4 
Adverse Event Relationship ........................................................................................... 7 
9.5 
Adverse Event Recording .............................................................................................. 7 
9.6 
Adverse Event Reporting ............................................................................................... 7 
10.0         INVESTIGATOR RESPONSIBILITIES, RECORD AND REPORTS ................................ 7 
10.1 
Subject Consent and Information ................................................................................... 7 
10.2 
Subject Data Protection ................................................................................................. 7 
10.3 
Staff Information ............................................................................................................. 8 
10.4 
Protocol Reviews............................................................................................................ 8 
10.5 
Investigator Records ...................................................................................................... 8 
10.6 
Investigator Reports ....................................................................................................... 8 

 
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 11.0  
REFERENCES……………………………………………………………….………………….8 
APPENDIX A: Case Report Forms .............................................................................................. 9 
 
PROTOCOL SYNOPSIS 
Protocol Title: 
Preoperative Mindfulness Meditation for Total Knee 
Arthroplasty: A Pilot Study 
Protocol Number: 
2023-2131 
Protocol Date: 
 
Sponsor: 
Anesthesiology Research Department 
Principal 
Investigator: 
Christopher Li, MD 
Products: 
N/A 
Objective: 
This study will investigate the effect of a preoperative 
mindfulness meditation intervention (MMI) on outcomes for total 
knee arthroplasty (TKA) patients at the Hospital for Special 
Surgery in a randomized controlled trial. 
Study Design: 
Randomized Clinical Trial 
Enrollment: 
30 
Subject Criteria: 
Inclusion: 
• 
Adult patients undergoing primary total knee arthroplasty 
with a participating surgeon 
• 
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 
• 
Patients receiving intraoperative auricular acupuncture 
as part of participating surgeon’s preferred anesthetic 
care 
• 
Patients fluent in English 
• 
ASA I-II 
• 
BMI < 40 
Exclusion: 
• 
Patient not fluent in English (inability to understand the 
intervention video will likely affect ability to utilize the 
mindfulness techniques taught) 
• 
Pediatric patients < 18 years of age 
• 
Patients with contraindications to intra-op protocol 

 
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• 
Patients with contraindications to auricular acupuncture 
(non-native ear, active ear infection, gauges in the ears) 
• 
Patients unable/unwilling to participate in the 
questionnaires or listen to the scripted intervention  
• 
Patients scheduled for consecutive or staged surgeries  
• 
Patients allergic to local anesthetics or study medications 
• 
Patients who have kidney disease 
Study Duration: 
• 
6 months 
Data Collection: 
Sources: EPIC, Medical Records, and Patient Reported 
 
Variables: Name, MRN, Date of birth, Email, Race, Gender, 
Ethnicity, Height, Weight, Body mass index, Co-morbidities, 
Medications to manage pre-existing conditions, Surgery details, 
Anesthesia details, DVT prophylaxis medications ordered and/or 
administered, PHQ-9, GAD-7, PROMIS Global health v1.2, Brief 
resilience scale, NRS pain scale, Pain unpleasantness scale, 
KOOS-Jr, Pain catastrophizing scale, MMI Practice survey, 
Patient satisfaction survey, Exit survey 
Statistical Analysis: 
Proposed analysis: 
t-test as there are two groups 
Interim analysis planned? No 
Alpha level: 0.05 
Beta or power level: N/A Pilot study 
Number of groups being compared: 2 
Resulting number per group: 12 
Total sample size: 30 (20% standard anticipated drop out rate) 
 
 
 

 
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1.0 INTRODUCTION 
Total joint arthroplasty is a commonly successful, elective procedure that, with an aging 
population that is experiencing a higher incidence of obesity, is significantly increasing in 
implementation. While patients are usually satisfied post-operatively some are afflicted with 
anxiety, depression, and/or pain catastrophizing. This mental status is often correlated with    
worse postoperative functional outcomes, patient satisfaction, and greater postoperative 
pain experience. Novel interventions are needed to address this mental status optimization 
issue for these patients with the goal of improving patient satisfaction, perception of pain, 
and symptoms of anxiety/depression for TKA.   
2.0 OBJECTIVE OF CLINICAL STUDY 
This study will investigate the effect of a preoperative mindfulness meditation intervention 
(MMI) on outcomes for total knee arthroplasty (TKA) patients at the Hospital for Special 
Surgery in a randomized controlled trial. 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. It has been used for numerous psychological issues including stress, 
anxiety, and depression. 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). This control has been 
utilized in several mindfulness meditation studies. 
3.0 STUDY HYPOTHESES 
Hypothesis 1: We hypothesize that this MMI will be feasible here at HSS and that we will 
successfully recruit, enroll, and analyze the data from this pilot study. 
Hypothesis 2: We hypothesize that this pilot study will provide an estimate of both the 
control and intervention group’s central tendency and variability. 
Hypothesis 3: We hypothesize that in a study with sufficient power, the MMI will have a 
positive effect on mental and physical health as well as patient satisfaction scores. We 
hypothesize that in this study, the MMI will increase resilience scores within the intervention 
group. 
4.0 STUDY DESIGN 
 
4.1 
Study Duration 
6 months 
 
4.2 
Endpoints 
 

 
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4.2.1 
Primary Endpoint 
• 
Feasibility: The MMI practice survey and the exit survey (ease, helpfulness of 
MMI) helps to assess enrollment, retention, intervention completion and use 
measured by time to full enrollment, dropout number/proportion, number of 
MMI views/uses. The MMI practice survey is asked to the intervention group 
in pre-operative holding, post-operative day 14 and post-operative day 90. 
The exit survey is given to the intervention group on post operative day 14 
and given 2 weeks after post-operative day 90. 
• 
Mental health: Anxiety and depression severity, overall mental health scores, 
resilience. PROMIS Mental Health Questionnaire is to assess general mental 
health in patients 1 week prior to surgery, post operative day 14, and post 
operative day 90.  Generalized Anxiety Disorder Assessment (GAD-7) to 
assess severe anxiety in patients 1 week prior to surgery, post operative day 
14, and post operative day 90. The Patient Health Questionnaire (PHQ-) is to 
assess depression in patients 1 week prior to surgery, post operative day 14, 
and post operative day 90. 
• 
Physical health: Function and overall physical health. PROMIS Physical 
Health Questionnaire is used to assess general physical health in patients 1 
week prior to surgery, post operative day 14, and post operative day 90. The 
KOOS-JR questionnaire will assess knee health after a total knee 
replacement surgery 1 week prior to surgery, and preoperative holding. 
4.2.2 
Secondary Endpoints 
• 
Pain outcomes: Pain severity. The Pain Unpleasantness scale which 
describes pain via a verbal descriptor at 1 week prior to surgery, day of surgery, 
post-acute care unit (PACU), post operative day 14, and post operative day 90. The 
pain catastrophizing scale assess pain experience and ability to cope with pain 1 
week prior to surgery. The NRS assesses pain levels on a scale from 0-10 in the 
operative knee 1 week prior to surgery, day of surgery, post-acute care unit (PACU), 
post operative day 14, and post operative day 90. 
• 
Resilience training: The Brief Resilience Scale is used to assess the ability to 
recover from stress 1 Week prior to surgery, post operative day 14, and post 
operative day 90 
• 
Patient satisfaction: The patient satisfaction survey will assess patient 
satisfaction with results of the total knee replacement surgery taken on post 
operative day 14. 
 
4.3 
Study Sites 
Hospital for Special Surgery – Main Campus 
5.0 STUDY POPULATION 
5.1 
Number of Subjects 
A total of 30 subjects will be enrolled 
 
 

 
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5.2 
Inclusion Criteria 
Subjects of either gender will be included if they: 
• 
Adult patients undergoing primary total knee arthroplasty with a participating surgeon 
• 
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 
• 
Patients receiving intraoperative auricular acupuncture as part of participating 
surgeon’s preferred anesthetic care 
• 
Patients fluent in English 
• 
ASA I-II 
• 
BMI < 40 
 
5.3 
Exclusion Criteria 
Subjects will be excluded from the study if they: 
• 
Patient not fluent in English (inability to understand the intervention video will likely 
affect ability to utilize the mindfulness techniques taught) 
• 
Pediatric patients < 18 years of age 
• 
Patients with contraindications to intra-op protocol 
• 
Patients with contraindications to auricular acupuncture (non-native ear, active ear 
infection, gauges in the ears) 
• 
Patients unable/unwilling to participate in the questionnaires or listen to scripted 
intervention.  
• 
Patients scheduled for consecutive or staged surgeries.  
• 
Patients allergic to local anesthetics or study medications 
• 
Patients who have kidney disease 
 
5.4 
Randomization 
A computer-generated, 1:1 ratio randomization schedule with blocks of sizes 4 and 6 will be 
created by a statistician not otherwise involved in the study. 
Participants will be randomized to 1 of 2 groups: 
• 
Group 1 will receive the Mindfulness Meditation Intervention prior to their day of 
surgery. 
• 
Group 2 will receive the Mindfulness Meditation Intervention 90 days after their day 
of surgery 
  
6.0 PROCEDURES 
6.1 
Surgical Procedure 
 
Total knee arthroplasty 

 
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6.2 
 Medical Record Requirements 
Epic 
6.3 
Data Collection 
 
The following data will be collected: 
 
Pre-operative/Baseline 
• 
basic demographic data 
• 
patient weight & height, BMI 
 
Surgical procedure 
• 
date of surgery 
• 
type of surgery 
• 
anesthesia details 
 
Follow-up visits (Pre-intervention, DOS, PACU, 14 days post-op, 90 days post-op) 
• 
PHQ-9 
• 
GAD-7 
• 
PROMIS Global Health v1.2 
• 
Brief resilience scale 
• 
NRS Pain Scale 
• 
Pain Unpleasantness Scale 
• 
KOOS-JR 
• 
Pain catastrophizing scale 
• 
MMI Practice Survey 
• 
Patient Satisfaction Survey 
• 
Exit Survey 
 
 
 

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6.4 
Schedule of Assessments 
Procedures 
Pre-
Intervention 
Day of 
Surgery 
PACU 
14 days 
post-op 
90 days 
post-op 
2 Weeks 
post-MMI 
Identify eligible patients before 
surgery 
X 
 
 
 
 
 
Obtain e-consent 
X 
 
 
 
 
 
Access to MMI 
X 
(Intervention 
group) 
 
 
 
X 
(Intervention 
Group) 
 
PHQ-9 
X 
 
 
X 
X 
 
GAD-7 
X 
 
 
X 
X 
 
PROMIS Global Health v1.2 
X 
 
 
X 
X 
 
Brief Resilience Scale 
X 
 
 
X 
X 
 
NRS Pain Scale 
X 
X 
 
X 
X 
 
Pain Unpleasantness Scale 
X 
 
X 
X 
X 
 
KOOS-JR 
X 
 
 
X 
X 
 
Pain catastrophizing Scale 
X 
 
 
 
 
 
MMI Practice Survey 
 
X 
 
X 
X 
 
Pain satisfaction survey 
 
 
 
X 
 
 
Exit Survery 
 
 
 
X 
(Intervention 
Group) 
 
X 
(Intervention 
Group) 

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7.0 STATISTICAL ANALYSIS 
Proposed analysis: 
t-test as there are two groups 
Interim analysis planned? No 
Alpha level: 0.05 
Beta or power level: N/A Pilot study 
Number of groups being compared: 2 
Resulting number per group: 12 
Total sample size: 30 (20% standard anticipated drop out rate) 
 
 
8.0 ADVERSE EVENT ASSESSMENT 
All Adverse Events (AEs) will be reported in the final study report. Definitions for Adverse 
Event (AE) used in this study are listed below and are based on FDA and international 
guidelines: 
 
8.1 
Adverse Event (AE) 
Any untoward medical occurrence in a patient or clinical investigation subject 
administered a pharmaceutical product which does not necessarily have to have a 
causal relationship with this treatment. An adverse event (AE) can therefore be any 
unfavorable and unintended sign (including an abnormal laboratory finding, for 
example), symptom, or disease temporally associated with the use of a medicinal 
(investigational) product, whether or not considered related to the medicinal 
(investigational) product. 
 
8.2 
Serious Adverse Events (SAE) 
The event is serious and should be reported to FDA when the patient outcome is: 
Death, Life-threatening, Hospitalization (initial or prolonged), Disability or Permanent 
Damage, Congenital Anomaly/Birth Defect, Required Intervention to Prevent 
Permanent Impairment or Damage (Devices), Other Serious (Important Medical 
Events). 
 
8.3 
Adverse Event Relationship 
Relationship to study: definitely, probably, possibly, not related. 
 
 

 
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9.0 INVESTIGATOR RESPONSIBILITIES, RECORD AND REPORTS 
 
9.1 
Subject Consent and Information 
Research assistants will screen the co-investigating surgeons' patients undergoing 
ambulatory total knee arthroplasty surgery. Screening will involve reviewing the 
patient's EPIC chart to ensure that they meet the inclusion criteria and are not 
excluded due to any of the exclusion criteria listed. Patients who meet the inclusion 
criteria will be identified as potential study participants. After the investigating 
anesthesiologists have confirmed the eligibility of all potential participants, one of the 
investigating anesthesiologists will approach the potential patients in the pre-operative 
holding area, explain the rationale for the study, and ask if the patient is interested in 
participating. 
 
9.2 
Subject Data Protection 
Subject privacy and confidentiality will be maintained through the storage of study data 
in a password-protected computer database maintained by the Research Director and 
accessible only to the principal investigator, in addition to other IRB-approved study 
personnel. Each subject will be assigned a unique study number for identification in 
the study database. This unique study number will not be derived from or related to 
information about the individual. The key linking this unique study number to patient 
identifiers (i.e., name, medical record number, date of birth, registry number) will be 
maintained in a different password-protected database maintained by Research 
Director, to which only the primary investigator will have access. 
 
9.3 
Staff Information 
Primary Investigator: Christopher Li, MD 
Research Assistant: Angela Puglisi, 646-714-6849 
Research Assistant: Marko Popovic, 646-797-8948 
 
9.4 
Protocol Reviews 
Study protocol reviewed and approved by: 
• 
Anesthesiology CRP 
• 
Hospital for Special Surgery Institutional Review Board 
 
10.0 REFERENCES 
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 Acupuncture as Part of a Multimodal Analgesia Regimen to Reduce Opioid Usage
 
 After Total Knee Arthroplasty: A Prospective Cohort Trial. Medical Acupuncture. 
 
34(1):49-57. 

 
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preoperative mind-body therapies for total joint arthroplasty patients: a randomized 
 
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Hirschmann MT, Testa E, Amsler F, Friederich NF. 2013. The unhappy total knee 
 
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2013 Jan 29. 
Hofmann SG and Gomez AF. 2017. Mindfulness-Based Interventions for Anxiety and 
 
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Jones AR, Al-Naseer S, Bodger O, James E.T.R, Davies AP. 2018. Does pre-operative 
 
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Predictors of outcomes of total knee replacement surgery. Rheumatology (Oxford). 
 
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