Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation
Phase: NA
Conditions: Peripheral Vascular Disease
Sponsor: Massachusetts General Hospital

 
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Jan 17 
2024 
Study Protocol and 
Statistical Analysis Plan   
  
GUIDED MEDITATION TO DECREASE PERIOPERATIVE ANXIETY 
AND INCREASE PATIENT INTRAOPERATIVE COMPLIANCE IN 
VASCULAR SURGERY 
NCT ID: 2021P002072 

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Intervention/Interaction Detailed Protocol 
 
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Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
 
Principal Investigator: 
Anahita Dua, MD 
 
Project Title: 
Decreasing Sedative Requirements for Peripheral Vascular 
Interventions using Preoperative Guided Meditation 
 
Version Date: 
Jan 17, 2024 
 
 
For Intervention/Interaction studies, submit a Detailed Protocol that includes the following 
sections.  If information in a particular section is not applicable, omit and include the other 
relevant information.   
 
 
1. 
 Background and Significance 
 
Undergoing surgery is a life-altering event, and patients understandably often have severe anxiety prior to 
and during their surgical procedure. This can poorly impact procedural outcomes not only by causing 
perioperative hemodynamic instability, but in the case of patients undergoing conscious sedation, impact 
their ability to comply with perioperative provider instructions.1 In addition to this, increased preoperative 
anxiety can result in increased anesthetic requirements in the form of short-acting benzodiazepines and 
opioids.2 These pharmacologics not only have short term side effects including respiratory depression 
and possible apnea but can also in some cases result in addiction and long-term dependence.3  
Guided meditation is a non-pharmacologic intervention that has proven to be effective in decreasing 
anxiety.4, 5  This intervention has recently been adapted to the perioperative area, with several recent 
trials yielding promising results: meditation not only resulted in decreased perioperative biomarkers of 
anxiety and stress6 but also resulted in decreased postoperative pain in the specialties of cardiac and 
spine surgery.7 Several guided meditation techniques exist, including the body-scan technique which 
involves sequentially increasing one’s awareness of each body part addressed, as well as breath-focused 
meditation which involves repeated controlled timed deep inhalations and exhalations – which is in 
contrast to the physiological effect of anxiety -- rapid and shallow breathing. 
Of note, prior and currently ongoing trials have all involved general anesthesia, and none have enrolled 
patients under conscious sedation.  It is worth noting that in vascular surgery, minimally invasive 
endovascular techniques have overtaken open surgical techniques in the management of Peripheral 
Vascular Disease (PVD).  As these procedures do not require general anesthesia, many providers have 
moved from the operating room to ambulatory vascular centers or office-based laboratories to perform 
these procedures under conscious sedation.8 At the same time, without general anesthesia or paralytics, 
patients are required to perform tasks such as keeping their extremity still or intermittently holding their 
breath for extended periods of time.  Patients which are unable to completely comply can be subject to 
repeated imaging attempts, which result in additional doses of contrast administration and ionizing 
radiation. 
 

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Anecdotal data suggests that increased perioperative anxiety increases the likelihood that a patient is 
unable to hold their extremities still or hold their breath for extended periods of time during the 
catherization procedure.  By extension, high perioperative anxiety is likely to be associated with increased 
contrast administration and radiation dose. 
We propose to quantify the severity of perioperative anxiety in the form of State Trait Anxiety Inventory 
(STAI) scores, which we will then address via a guided meditation program that revolves around a body-
scan and deep-breathing meditation. We will also collect data regarding Interoceptive Awareness using 
the Noticing subscale of the Multidimensional Assessment of Interoceptive Awareness (MAIA) score. The 
ultimate goal of this research is to decrease patient perioperative anxiety and thereby not only improve 
the perioperative patient experience but also increasing patient intraoperative compliance and thus 
reducing operative contrast administration and radiation doses. 
2. 
Specific Aims and Objectives  
 
We have one specific aim:  
1. To test the feasibility and acceptability of a preoperative guided meditation program on patients 
undergoing vascular surgical procedures for peripheral vascular disease. 
 
3. 
General Description of Study Design 
 
This will be a prospective randomized controlled trial of patients undergoing peripheral vascular 
interventions.  Participants will be randomized to receiving guided meditation during their preoperative 
history and physical exam versus a standard preoperative history and physical exam on the day of their 
procedure. Randomization will be performed based on a randomization mobile application.  
 
Schema: 
Patient 
consents to 
vascular 
procedure 
AND consents 
to trial 
 
Randomize => 
Intervention group: 
Guided meditation 
program 
preoperatively 
=> 
Vascular 
Procedure 
 
=> 
 
 
 
 
=> 
Control group: No 
guided meditation 
preoperatively 
(standard of care) 
=> 
 
 
 
 
4. 
Subject Selection 
Inclusion Criteria: Patients who are >18 years of age who are undergoing an endovascular procedure 
for a peripheral vascular disease indication with an anesthetic plan for conscious sedation 
Exclusion Criteria:  
Patient related: 

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1. who have an associated significant psychiatric disorder such as anxiety, panic disorder, 
depression, psychosis, or bipolar disorder 
2. patients who are unable to give informed consent 
3. patients who are non-English speaking 
4. patients who are pregnant 
5. patients with a prior lower extremity amputation 
6. patients with chronic sensorimotor deficits of either lower extremity 
 Procedure related: 
1. procedures that are booked as urgent or emergent;  
2. procedures that are a combination of an open and endovascular procedure (e.g. an angiogram 
with a toe amputation) 
Recruitment Procedures: 
Providers: All vascular surgical attendings and trainees that perform PVIs at Massachusetts General 
Hospital, Newton Wellesley Hospital, Salem Hospital and Southern New Hampshire Hospital will be 
notified of this study at an in-person research meeting prior to enrollment of any patients.  Should they 
give verbal consent, they and their patients will be eligible to participate in this study moving forward.  The 
vascular surgery attending will likely be the provider answering the post-procedure provider survey, 
unless they for some reason are not the attending provider during the procedure; if such is the case, the 
provider performing the procedure will fill out the post-procedure provider survey- if they had been part of 
the group that had consented during the in-person research meeting. Otherwise, they will not be 
requested to fill out the post-provider survey.  These will be the same providers that fill out the post-
procedural provider questionnaire, which will be completed electronically, in person using an iPad and 
anticipated to take no longer than 3 minutes to fill out. 
Patients: All patients will be personally screened by the vascular surgical attending who they are known to 
or had been referred to in the case of new patient. This vascular surgical attending will then (1) give 
approval for his/her patient to be contacted for research purposes, (2) initially introduce the study to the 
patient AND (3) obtain the patient's permission to be contacted by study staff. Patients will be consented 
initially either at the preoperative surgical clinic visit or prior to the day of surgery in person if they are 
inpatient or via telephone if they are not inpatient.  If the patients are not inpatient, they will be provided 
the fact sheet prior to their procedure and intervention on the day of their intervention.  Subjects will be 
given the details about the study and given adequate time to ask questions and talk the study over with 
family that accompanies them.  
The principal investigator or the co-investigators will be responsible for enrolling the patients. 
Specific recruitment methods will not be used to enhance recruitment of women or minorities – we aim to 
enroll a patient population which is representative of the PVD demographic.  Members of a minority race 
and Hispanic patients will be included in this study in a manner exactly the same as white patients and 
non-Hispanic patients so long as they meet the inclusion criteria. Given that the Massachusetts General 
Brigham has a large catchment pool, we expect the recruitment pool will adequately reflect the 
prevalence rates in the community, including proportions of minorities of race or ethnicities.  
 
 
5. 
Subject Enrollment 
 
All patients will be screened initially either at the preoperative surgical clinic visit or prior to the day of 
surgery in person if they are inpatient or via telephone if they are not inpatient.  Subjects will be given the 

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details about the study and given adequate time to ask questions and talk the study over with family that 
accompanies them.  
There will be no separate description for children as they will not be enrolled. 
Given that the script for the guided meditation is in English, non-English speakers will not be enrolled. 
Given the cognitive requirements to perform meditation, any patient who is unable to provide their own 
surgical consent will not be enrolled. 
The investigators’ own patients will be enrolled; however in this situation, a co-investigator will perform 
the enrollment to minimize the potential for coercion.  It will additionally be emphasized that the decision 
to enroll in the study will not in any other way affect their perioperative clinical care. They will also be 
advised that they may withdraw from the study at any point at their request. 
The post-consent intervention randomization method will be via a randomization application – with block 
randomization per study site.  
 
 
6. 
STUDY PROCEDURES 
 
 
Study Visits: 
Timing 
Location 
Procedure/Data Collected 
At least one day 
prior to day of 
vascular 
intervention: 
When decision is 
made to proceed 
with vascular 
intervention 
Outpatient Clinic 
vs Inpatient 
Ward 
Screening and consent for enrollment into trial 
Preoperative Quality of Life survey (PROMIS-10) 
Day of vascular 
intervention: 
30 minutes 
preoperatively, 
after surgical and 
anesthesia 
consents are 
obtained 
Pre-operative 
holding area 
Randomization 
Pre-meditation STAI-6 if randomized to intervention arm 
Guided Meditation if randomized to intervention arm 
Pre- procedural STAI-6 
Pre-procedural MAIA (Noticing subscale) 
Day of vascular 
intervention: 
2 hours after 
vascular 
intervention 
Post-anesthesia 
care unit 
Post-procedural Patient Questionnaire 
Post-procedural Provider Questionnaire 
Post-procedural MAIA (Noticing subscale) 
Outpatient follow-
up  
Typically between 
two weeks to one 
month after 
procedure 
Outpatient Clinic 
Follow-up Patient Questionnaire 
Followup Quality of Life survey (PROMIS-10) 
 

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Study Intervention: A guided meditation using the body scan technique, which will have two sessions- 
the first session while the patient is in the perioperative holding area and the second session after the 
patient has been positioned on the operating room table, however this second session will still be 
completed prior to the beginning of the surgery.  This will be administered via a set of Bluetooth 
headphones (with bone-conduction technology so they do not cover the patients ears), with the 
associated audio recording being played from an MGB iPad.  This protocol, specifically regarding having 
one session in the perioperative holding area and one session in the operating room was designed by a 
multidisciplinary panel which included vascular anesthesiologists, perioperative nurses, integrative 
medicine clinicians and surgeons. this expert panel agreed that the protocol in this form would be most 
beneficial to the patients and simultaneously cause minimal (if any) disruption to the current operating 
room workflow.   
 
We will use a transcription modified from one of Jon Kabat-Zinn’s body scan meditation videos, with his 
explicit approval.  Dr. Jon Kabat-Zinn is a Professor Emeritus of Medicine and the creator of the Stress 
Reduction Clinic and the Center for Mindfulness in Medicine, Health Care, and Society at the University of 
Massachusetts Medical School.  As the creator of mindfulness-based stress reduction and the author of 
two national bestsellers on the topic, he is regarded as one of the thought-leaders in the mindfulness 
field. 
Data collection logistics:  These sheets will be completed electronically, in person using an MGB iPad .  
Each sheet is anticipated to take no longer than 3 minutes to fill out. 
PROMIS-10 score: The PROMIS-10 is a measurement system developed by the NIH to assess health 
and wellbeing in adults and children from the general population, as well as those living with chronic 
conditions. The PROMIS 10 is a comprehensive and accessible set of tools used to measure self-
reported physical, mental and social health; including symptoms, function and general perceptions of 
health and wellbeing. This score will serve to collect baseline and post-intervention quality of life data. 
STAI-6 score: The STAI-6 includes six questions with a Likert scale from 1 to 4 for a range of 6 to 24.  
For context, the original STAI has two components; a state portion which evaluates the current state of 
anxiety a patient has in a clinical setting, and a trait portion which evaluates how the patient generally 
feels unrelated to the clinical setting. Each of these sections has 20 items to answer and approximately 
takes 10-15 minutes to complete.  There exists a shortened six question version of the state portion which 
only takes a few minutes to complete and is highly correlated with the full state STAI.9  As such, we will 
be using the STAI-6 form questionnaire to measure anxiety levels in our patient population. 
MAIA score (Noticing subscale): The Multidimensional Assessment of Interoceptive Awareness is self-
reported multidimensional instrument with eight separately scored scales.  The three scales each have 
between three and seven questions that combine to provide an assessment of a patient’s interoception 
(awareness of bodily sensations).  Each subscale can be separately administered with the retention of its 
psychometric features; we chose to administer the first subscale “Noticing” to strike a balance between 
assessment fidelity and question-fatigue. 
Return of Study Results: The study data will be collected by study staff and electronically converted into 
a spreadsheet to be stored in LabArchives. The principal investigator will be responsible for managing 
incidental findings.  
Primary outcome: Patient pre-procedural anxiety as measured by STAI-6 scores  
Secondary outcome: Secondary outcomes will include provider and patient satisfaction scores, 
intraoperative patient ability to perform breath holds and to maintain leg immobility, and the extent to 
which additional contrast or radiation was required during the procedure.  These will be assessed in the 
form of post-procedure questionnaire and measured on a Visual Analogue Scale. 
 

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Study termination criteria: 
 
Individuals may withdraw from the study at any time without impact to their care. They may also be 
discontinued from the study at the discretion of the Investigator for lack of adherence to intervention or 
study procedures or AEs. It will be documented whether or not each subject completes the study.  
 
Should the subject’s participation in the trial be terminated early, the rest of their care, namely their 
vascular intervention, will proceed as if they had not been in the trial to begin with. 
 
The study itself will be terminated should there be serious adverse events resulting directly from the 
intervention as described in the Monitoring and Quality assurance section. 
 
No remuneration will be offered to the trial participants. 
 
There will be no plans to send or receive data with research collaborators outside Mass General Brigham.  
 
 
7. 
Risks and Discomforts 
 
Meditation is widely accepted as a harm-free intervention, though one potential risk of the guided 
meditation is increased anxiety due to increased awareness of their limitations with breath-holds, if 
applicable.  This will be mitigated by excluding patients with known anxiety disorders. 
 
From a privacy standpoint, the results of the questionnaires including anxiety scores will not be added to 
the patient’s medical record, as such only pre-authorized research staff will have access to them. 
 
There are no foreseeable additional risks other than the risks inherent to the vascular intervention itself 
which is standard of care and patients will separately consent to. 
 
8. 
Benefits 
 
Potential benefits: 
Intervention group: Possible benefits include potentially decreased perioperative anxiety, reduced 
operative contrast administration and reduced radiation doses. 
Healthy controls: No potential benefit 
 
Potential benefits to study population in society: 
Should our intervention prove to be effective in reducing patient anxiety, the adoption of preoperative 
guided meditation programs will likely benefit a significant fraction of the PAD patient population and by 
not only decreasing patient perioperative anxiety but also increasing patient safety by reducing operative 
contrast administration and radiation doses. 
 
 
9. 
Statistical Analysis 
Statistical analyses will be performed using STATA 15 statistical software (College Station, TX). 
Demographic or other categorical data will be analyzed using T test or Fishers exact test as appropriate. 
Interval measurements (STAI-6 scores) will be analyzed by using the t-test or Mann-Whitney test as 
appropriate.  

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Power Analysis:  
This is a pilot study to assess the feasibility and acceptability of an intervention and to gather preliminary 
data to adequately power a future trial, and as such there will not be any power analysis for this study. 
 
10.   Monitoring and Quality Assurance 
 
 
Adverse event criteria 
 
Adverse Event  
any symptom, sign, illness or experience that develops or worsens in severity during the course of the 
study. Intercurrent illnesses or injuries should be regarded as adverse events. Abnormal results of 
diagnostic procedures are considered to be adverse events if the abnormality:  
•  results in study withdrawal  
•  is associated with a serious adverse event  
•  is associated with clinical signs or symptoms  
•  leads to additional treatment or to further diagnostic tests  
•  is considered by the investigator to be of clinical significance  
 
Serious Adverse Event 
any event temporally associated with the subject’s participation in research that meets any of the 
following criteria:  
• 
results in death;  
• 
is life threatening (places the subject at immediate risk of death from the event as it 
occurred);  
• 
requires inpatient hospitalization or prolongation of existing hospitalization;  
• 
results in a persistent or significant disability/incapacity;  
• 
results in a congenital anomaly/birth defect; or  
any other adverse event that, based upon appropriate medical judgment, may jeopardize the 
subject’s health and may require medical or surgical intervention to prevent one of the outcomes 
listed above (examples of such events include allergic bronchospasm requiring intensive 
treatment in the emergency room or at home, blood dyscrasias or convulsions that do not result 
in inpatient hospitalization, or the development of drug dependency or drug abuse).  
 
Adverse Event Reporting: The Principal Investigator and study staff will review all adverse events 
experienced by any subjects as a result of this study.  The PI will supervise the assessment of 
relationship of each adverse even to the study procedures. The adverse events, if any occur, will be 
classified as definitely related, probably related, possibly related, unlikely or unrelated.  Additionally, all 
adverse events will be reported following the Mass General Brigham IRB guidelines for Adverse Event 
Reporting. 
 
Data and Planned Safety Monitoring: The PI, Dr. Dua and her collaborator Dr. Png will be responsible 
for data safety and monitoring. All paper data will be kept in a locked cabinet in the MD collaborator’s 
office. Safety and outcomes reviews will be performed after each consecutive enrollment of 25 patients. 
 
Termination of Study: The study itself will be terminated should there be serious adverse events that are 
classified as definitely related to and directly resulting from the intervention. 
 
Internal Monitoring of Source Data and Protocol Adherence: All monitoring and quality assurance will 
be done through Harvard Catalyst every 3 months and more frequently as needed. This will be performed 
through a statistician who works closely with the vascular surgery department through our research office. 
They will be responsible for reviewing data and verifying its accuracy and completeness.  
 

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11.   Privacy and Confidentiality 
 
 
☐ Study procedures will be conducted in a private setting 
☒ Only data and/or specimens necessary for the conduct of the study will be collected 
☒ Data collected (paper and/or electronic) will be maintained in a secure location with 
appropriate protections such as password protection, encryption, physical security 
measures (locked files/areas) 
☐ Specimens collected will be maintained in a secure location with appropriate protections 
(e.g. locked storage spaces, laboratory areas) 
☒ Data and specimens will only be shared with individuals who are members of the IRB-
approved research team or approved for sharing as described in this IRB protocol 
☒  Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password 
protection, using chain-of-custody procedures, etc.) 
☒   All electronic communication with participants will comply with Mass General Brigham 
secure communication policies 
☒ Identifiers will be coded or removed as soon as feasible and access to files linking 
identifiers with coded data or specimens will be limited to the minimal necessary 
members of the research team required to conduct the research 
☒ All staff are trained on and will follow the Mass General Brigham policies and 
procedures for maintaining appropriate confidentiality of research data and specimens 
☒ The PI will ensure that all staff implement and follow any Research Information Service 
Office (RISO) requirements for this research 
☐ Additional privacy and/or confidentiality protections 
 
 
 
12.   References 
 
 
 
1. 
Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst 
Rev. 2013(6):CD006908. 
2. 
Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth 
Analg. 1999;89(6):1346-51. 
3. 
Wright JD, Cogan JC, Huang Y, Tergas AI, St Clair CM, Hou JY, et al. Association of New 
Perioperative Benzodiazepine Use With Persistent Benzodiazepine Use. JAMA Netw Open. 
2021;4(6):e2112478. 
4. 
Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, et al. Effectiveness of a 
meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 
1992;149(7):936-43. 
5. 
Hoge EA, Bui E, Marques L, Metcalf CA, Morris LK, Robinaugh DJ, et al. Randomized controlled 
trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. J 
Clin Psychiatry. 2013;74(8):786-92. 

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6. 
Kiran U, Ladha S, Makhija N, Kapoor PM, Choudhury M, Das S, et al. The role of Rajyoga 
meditation for modulation of anxiety and serum cortisol in patients undergoing coronary artery bypass 
surgery: A prospective randomized control study. Ann Card Anaesth. 2017;20(2):158-62. 
7. 
Chavez JL, Porucznik CA, Gren LH, Guan J, Joyce E, Brodke DS, et al. The Impact of Preoperative 
Mindfulness-Based Stress Reduction on Postoperative Outcomes in Lumbar Spine Degenerative Disease: 
3-Month and 12-Month Results of a Pilot Study. World Neurosurg. 2020;139:e230-e6. 
8. 
Mukherjee D, Hashemi H, Contos B. The disproportionate growth of office-based atherectomy. 
Journal of vascular surgery. 2017;65(2):495-500. 
9. 
Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the 
Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992;31(3):301-6.