Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA
Phase: NA
Conditions: Preprocedure Anxiety
Sponsor: Corewell Health West

 
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1. Protocol Title: impact of Virtual Reality on pre-procedural anxieTy prior to Heart 
cathEterIzAtion – VR-THEIA 
 
2. Investigators: Ryan Madder, MD; Stacie VanOosterhout, MEd; Abbey Mulder, RN, MSN  
 
3. Version Date: 19 August, 2021 
 
4. Objectives: 
The primary aim of this study is to test the hypothesis that use of VR combined with 
standard procedural education will result in less pre-procedural anxiety than standard 
procedural education alone among patients undergoing first-time cardiac catheterization. 
The VR technology being evaluated in this study will allow patients to experience a 3-D 
simulation of certain aspects of their upcoming procedure prior to the actual procedure date.  
 
5. Background: 
It has been reported that patients scheduled for cardiac catheterization experience 
considerable anxiety in anticipation of undergoing the procedure (1-3). This pre-procedural 
anxiety has the potential to adversely impact quality of life and could reduce overall patient 
satisfaction.  
 
Virtual reality (VR) is the computer-generated simulation of a three-dimensional (3-D) 
environment that can be interacted with in a seemingly real, or physical, manner (4).  VR 
technology, although previously expensive to produce and use, is becoming more 
affordable. When introduced into contemporary medical care, VR has the potential to alter 
the medical landscape and could be used in novel ways to improve patient satisfaction and 
clinical outcomes. The proposed study is being performed to determine if VR can be applied 
to reduce pre-procedural anxiety prior to cardiac catheterization.  
 
6. Setting of the Research: 
The research activities will be conducted at or from Spectrum Health outpatient offices and 
the Meijer Heart Center whenever possible. Potential participants will be called on the phone 
to discuss participation; if they agree to proceed, they will be met in person at an outpatient 
Spectrum Health facility, unless otherwise requested by the potential participant (e.g., if the 
would-be participant requests we meet her or him at an office or other public location and is 
comfortable conducting study activities in that locale, we would grant that request out of 
consideration for that participant’s wishes) for signing of consent and baseline activities. 
Study personnel will then meet the participant on the day of her or his procedure in the 
Meijer Heart Center Catheterization Lab to conduct the preprocedure activities.  
 
7. Resources Available to Conduct this Research: 
Members of the Cardiovascular Research team will be available to conduct this study. In 
fiscal year 2015-2016, 3,800 left heart catheterizations (LHC) were performed at the Meijer 
Heart Center. Approximately 35% of those procedures were first time LHC’s for the patient 
which equates to approximately 26 patients per week. If a minimum of 2 patients per week 
agreed to participate, the study team could enroll the target number of 172 participants (who 
successfully completed all study activities) and conclude all study activities in two years. 
Approximately 1% of the PI’s time and 10% of each coordinator’s/assistant’s time will be 
devoted to the conduct of this study. The aggregate research experience of the team, 
including the PI, is over 20 years and includes prospective, retrospective, randomized, 
industry sponsored, federally funded and investigator initiated studies.  

 
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The current team has enrolled over 250 participants in studies over the past two years and 
successfully followed participants, collected and reported data and contributed to multiple 
publications. 
 
The members of the team conducting this study are a subspecialty group within the 
Cardiovascular Research (CVR) Department. The CVR Department is comprised of five 
subspecialty teams totaling an average of 20 coordinators/nurses/assistants. The teams 
report to a cardiovascular research supervisor and the CVR Department is a subset of the 
Office of Research Operations at Spectrum Health. Our offices include individual works 
stations each (with computers connected to the SH servers and hospital software 
applications) for all staff, two conference rooms, a lab room, separate secure storage rooms, 
hoteling for monitors, a private office for leadership, high density storage and a full time 
secretarial administrator. 
 
8. Study Design: 
a. Recruitment Methods 
Patients scheduled for outpatient LHC will be screened for inclusion/exclusion criteria 
via the catheterization laboratory schedule. Upon review of those medical records, 
patients who appear to meet all inclusion criteria and have no exclusion criteria and 
whose procedure date allows for a baseline visit preprocedure will be called by study 
personnel to discuss study participation. Whenever possible, a PDF of the consent 
form will be sent to the patient directly (e.g. via email or fax). If the immediate 
transmission of a consent form is not technologically possible, study personnel will 
verbally present all elements of the study. If the patient chooses to proceed with 
participation, a date and time will be agreed upon to meet at an agreed upon location 
(Spectrum Health facility whenever amenable). At that visit, study personnel will 
again review all elements of the consent form, procure written consent and then 
proceed with baseline activities. A one-time gift card valued at $25.00 will be 
provided to the participant at the conclusion of the visit. The total number of 
participants to be enrolled in this study will be up to 200. 
 
b. Inclusion and Exclusion Criteria 
Inclusion Criteria 
▪ 
Scheduled to undergo a left-heart catheterization procedure at the Meijer 
Heart Center 
▪ 
18-75 years of age 
▪ 
Signed study consent form 
 
Exclusion Criteria 
▪ 
History of cardiac procedure(s) in a cardiac catheterization laboratory 
▪ 
History of seizures, migraine headaches or severe susceptibility to motion 
sickness 
▪ 
Currently taking psychotropic drugs or on long-term psychotropic treatment 
▪ 
Unable to read and speak English 
▪ 
Visually impaired 
▪ 
Unable to provide written consent 
 
c. Study Endpoints 
The primary measure of interest in the present study is patient anxiety, as measured 
using the State Trait Anxiety Inventory (2, 3).  

 
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In all patients, anxiety will be assessed using this tool at baseline (prior to 
randomization) and again on the day of the procedure, just prior to undergoing 
catheterization.  
 
The primary outcome of this study is the anxiety level measured just prior to 
catheterization, which will be compared in the two study groups. 
 
The preparedness tool results will be compared between the two groups as a 
secondary analysis.  
 
d. Procedures Involved in the Research 
 
Standard procedural education. Standard procedural education for all patients 
undergoing cardiac catheterization at our site formally comes from two sources. First, 
it is provided verbally by clinical personnel, including physicians and nurses, during 
routine clinical interactions (i.e. at the time of office visits) and during subsequent 
phone calls made by the patient to clinical personnel requesting additional 
procedural information. Second, clinical personnel provide all patients with an 
information sheet that describes cardiac catheterization (attached as Appendix A; 
also available online at www.kramesondemand.com).  
 
Virtual reality.  The VR experience developed for this study will be provided to 
participants by study personnel using a smartphone (Moto G, Motorola, 
Schaumburg, Illinois) and a viewer headset (View-Master, Mattel, Segundo, 
California). This interactive VR experience was filmed using a commercially available 
camera (360fly 4K, 360FLY, Pittsburgh, Pennsylvania) and developed using 
proprietary software by Carnevale Interactive (Grand Rapids, Michigan). The VR 
simulation will allow participants to experience aspects of their procedural day, 
starting with arrival in the lobby of the catheterization center. The simulation will 
progress to the catheterization laboratory registration and waiting room, followed by 
the pre-procedural holding area and finally the procedure room. In each location, the 
participant will be able to virtually explore the space and have the option of clicking 
on certain objects of interest, which will trigger an audio description of the object and 
its purpose.  
 
Visit 1 - Baseline. All participants will be required to meet with study personnel at an 
offsite locale (Spectrum Health facility whenever possible) prior to the scheduled 
LHC to conduct the baseline visit. Once informed consent is obtained, study 
personnel will administer the State Trait Anxiety Inventory (STAI) assessment to all 
participants.  
 
Randomization.  Following the completion of the STAI assessment, participants will 
be randomized in a 1:1 fashion to undergo either VR combined with standard 
procedural education or to standard procedural education alone. Prior to enrollment 
of the first participant, Spectrum Health Office of Research Administration 
statisticians (who are not be study personnel) provided the randomization 
assignment schema to Cardiovascular Research staff (also not study personnel). 
Each assignment was placed in an envelope in the order designated by the 
statisticians’ assignment schema. The envelopes were sealed and sequentially 
numbered from “1” to “200”. The envelopes were stored in the research office in the 
high-density storage area.  

 
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Due to the COVID-19 Pandemic, study personnel are now working primarily from 
home.  
 
In order to maintain the randomization schema as designed as well as reduce the 
need for staff to go into the hospital to collect randomization envelopes (thereby 
reducing their risk of exposure), the randomization process will be, for the remainder 
of the study, via REDCap database. The coordinator attending the enrollment visit 
will use REDCap to learn the randomization assignment for that participant while in 
the field, thus maintaining the blind. 
 
For participants randomized to standard procedure education alone, the baseline 
visit will be complete. Participants will be thanked (and provided a gift card) and 
remaining study activities will be reviewed. 
 
For participants randomized to VR intervention, the following will occur: 
 
▪ 
A  baseline wellness self-assessment will be administered (reporting on 
absence or presence and degree of severity of headache, nausea, dizziness, 
fatigue and vision abnormalities) 
▪ 
The participant will be asked to confirm she or he is seated comfortably and 
study personnel will ensure the chair and participant are free of direct 
obstruction 
▪ 
The participant will be shown the individual components of the VR system 
(View-Master with smartphone inserted; external speaker for audio projection; 
monitor for study staff to observe what the participant is experiencing), be 
given instructions on how to use the device and encouraged to ask questions. 
▪ 
Once the participant indicates she or he is ready, they’ll be asked to begin the 
VR experience. Study personnel will stay in the room with the participant for 
the entire duration and will be viewing on the monitor what the participant is 
experiencing virtually. Study personnel will provide guidance and answer 
questions regarding the technology and its use but will not answer questions 
regarding the facilities, prep, procedure or recovery (this will be explained 
prior to starting the VR experience).  
▪ 
When the participant indicates she or he is finished with the VR experience 
and has had a few minutes to orient, the wellness self-assessment will be 
administered again. 
▪ 
Participants will be thanked for their participation (and provided a gift card) 
and remaining study activities will be reviewed. 
 
Visit 2 – Procedure Day 
Study personnel will meet participants in their Prep/Recovery room prior to their 
procedure and the STAI assessment will be administered to all. A Retrospective 
Wellness questionnaire will be administered to the VR intervention group only in 
order to assess for any longer-term adverse effects (e.g., headache lasting several 
hours) of the VR experience. Postprocedure, a patient preparedness survey will be 
administered to all participants. All participants will again be thanked for their 
participation, all questions will be answered and their study participation will 
conclude. 
 
All of the above activities except for standard procedural education will be research 
related. The average study participation time frame for all participants will be less 
than 1 month.  

 
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The data collected for this study entails the State-Trait Anxiety Inventory results, 
wellness self-assessments results, preparedness survey results and meta-data 
results. 
 
e. Data Management 
The data collected for this study will comprise of survey results (State-Trait Anxiety 
Assessment; VR related wellness assessments; and a preparedness assessment) 
as well as demographic and medical history data (for general reporting purposes). 
The data will be collected directly from participants using paper tools, where after the 
responses will be entered into an electronic data capture (EDC) system. The study 
EDC will be housed on secure Spectrum Health servers and the paper documents 
will be stored in secure Spectrum Health facilities. 
 
f. 
Withdrawal of Subjects 
Participants may change their minds at any time and choose to withdraw from this 
study; however, there are no circumstances under which participants would be 
withdrawn without their consent. 
 
9. Statistical Plan 
a. Sample Size Determination 
Using G*Power 3.1.5 and looking at two sample independent t-test for the primary 
endpoint, in order to detect an effect size of 0.5 between the groups at 90% power 
and using significance level of 0.05, 86 patients are required in each study group. 
 
b. Statistical Methods 
Categorical variables will be reported as count (frequency). Normally distributed 
continuous variables will be reported as mean ± standard deviation and non-normally 
distributed continuous variables will be reported as median (interquartile range).  To 
determine if there is a difference in the two groups demographic variables a two 
sample t-test will be used for normally distributed continuous variables, a Mann 
Whitney Test will be used for non-normally distributed continuous variables, and a 
Chi-square will be used for categorical variables unless assumptions aren’t met then 
Fishers Exact test will be used. To compare the anxiety levels of the group of 
individuals randomized to VR and standard procedural education vs. standard 
procedural education alone an independent two sample t-test will be used. If 
assumptions aren’t met then a Mann Whitney test will be used. To determine if there 
is a difference in anxiety before and after the use of VR a paired t-test will be used. If 
assumptions aren’t met then a Wilcoxon Signed Rank test will be used. Significance 
will be assessed at an alpha of 0.05. 
 
10. Risks to Subjects 
Possible documented risks to using virtual reality include seizures; loss of awareness; eye 
strain; eye or muscle twitching; involuntary movements; altered, blurred, or double vision or 
other visual abnormalities; dizziness; disorientation; impaired balance; impaired hand-eye 
coordination; excessive sweating; increased salivation; nausea; lightheadedness; discomfort 
or pain in the head or eyes; drowsiness; fatigue; and/or motion sickness.  
 
About 1 in 4000 may have severe dizziness, seizures, eye or muscle twitching or blackouts 
triggered by light flashes or patterns, and this may occur while they are watching TV, playing 
video games or experiencing virtual reality, even if they have never had a seizure or 
blackout before or have no history of seizures or epilepsy. Such seizures are more common 

 
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in children and young people under the age of 20. These risks are generally associated with 
prolonged use and with the complete VR systems which entail large, fitted headsets and full 
body utilization. The VR hardware being used for this study is a reductive version (a hand-
held View-Master with a smartphone), the participants will be seated for the duration and the 
experiences will last 10-15 minutes. The participant will be in complete control and can set 
down the View-Master at any time as well as choose to discontinue the experience. 
 
11. Potential Benefits to Subjects 
There are no known benefits to using virtual reality prior to a medical procedure; however, it 
is possible that participation in the study could reduce preprocedureal anxiety for the 
intervention group. 
 
12. Provisions to Protect the Privacy Interests of Subjects 
Study personnel will conduct initial phone calls to patients and participants during routine 
business hours, unless otherwise requested by the recipient. Study personnel will routinely 
inquire if it is a good time to talk and if told it is not will ask for another, more convenient time 
to talk.  
 
In person meetings will take place within Spectrum Health facilities and all visits will be 
conducted in private spaces, unless otherwise requested by the participant. The baseline 
visits will be conducted in a setting where the equipment will be available and its use 
appropriate. The preprocedure visit will be conducted in the participant’s private 
Prep/Recovery room in the MHC Cath Lab. Study personnel will remain cognizant of others 
(staff, family, and friends) and will assess the participant for cues of distress or discomfort. If 
deemed necessary, study personnel may suggest to staff, family or friends that a few 
minutes of privacy is required to conduct the study activities.  
 
13. Provisions to Maintain the Confidentiality of Data 
Primary data related to this study will be maintained onsite at Spectrum Health in secure 
facilities or on secure Spectrum Health servers. Only study personnel will have access to the 
primary data. A single Excel spreadsheet correlation tool (excluding EDC/REDcap) will be 
maintained associating the participant’s name and DOB with her or his study ID; all other 
research tools and research documents will include only the subject’s study ID. The 
correlation tool and other research documents will be stored on the “M Drive” in a study 
specific folder to which only Spectrum Health research personnel should have access.  
 
REDcap is a Spectrum Health licensed and supported secure web application for building 
and managing online surveys and databases. Within REDcap, the VR-THEIA study will be 
accessible only to current, SH IRB approved study personnel.  The VR-THEIA database will 
contain PHI.  
 
If any data are shared with external sites for analysis, appropriate / applicable agreements 
will be executed (e.g., data use and/or research collaboration agreements) between 
involved parties prior to the sharing of those data. The shared data will be de-identified to 
the fullest extent possible. 
 
14. Cost to Subjects 
Participants will not incur any costs for participation in this study. 
 
15. Consent Process 
Potential participants will be identified via electronic record review. Those appearing to meet 
inclusion / exclusion criteria will be called over the phone. Study personnel will identify 

 
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themselves, explain their affiliation and purpose for calling. If the patient has time to talk, the 
study will be introduced. If the patient is interested in hearing the details, study personnel 
will proceed with explaining the details of the study. If the patient is interested in 
participating, study personnel will ask if a PDF of the consent form can be emailed or faxed 
directly (due to likely time constraints between the time the patient is identified and 
procedure date); if yes, study personnel will send the consent. If no, study personnel will 
review all sections of the consent over the phone.  
 
In the setting of sending the CF electronically, a follow up call will be conducted to learn the 
patient’s decision. In the setting of live review, the patient will be given the option to 
schedule a follow up call in order to allow them private time to consider participation. It will 
be explicitly requested that the CF not be signed prior to the baseline/enrollment visit. All 
interested patients will be scheduled for an enrollment/baseline visit with study personnel at 
a Spectrum Health outpatient office wherein the CF will be reviewed again in full and written 
consent will be obtained prior to the commencement of any study activities.  
 
16. Vulnerable Populations 
No vulnerable populations will be included for participation in this study. 
 
17. Sharing of Results with Subjects 
There are no plans to formally share the results of this study with the participants. If 
participants request information post participation, any published results would be 
shared. 
 
18. References 
1. Ripley L, Christopoulos G, Michael TT, et al. Randomized controlled trial on the impact of music 
therapy during cardiac catheterization on reactive hyperemia index and patient satisfaction. J Invasive 
Cardiol. 2014;26:437-42.  
2. Wu KL, Chen SR, Ko WC, et al. The effectiveness of an accessibility-enhanced multimedia 
informational education programme in reducing anxiety and increasing satisfaction of patients 
undergoing cardiac catheterization. J Clin Nurs. 2014;23:2063-73.  
3. Ayasrah SM, Ahmad MM. Educational video intervention effects on periprocedural anxiety levels 
among cardiac catheterization patients: a randomized clinical trial. Res Theory Nurs Pract. 
2016;30:70-84.  
4. Dugas CM, Schussler JM. Advanced technology in interventional cardiology: a roadmap for the 
future of precision coronary interventions. Trends in Cardiovasc Med. 2016;26:466-473.  
 
 
 
 
 
 
 
 
 
 
 
19. Appendices 
Appendix A – Cardiac Catheterization Information Sheet 

 
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Appendix B – State-Trait Anxiety Inventory (STAI) 

 
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Appendix C – Wellness Self Assessments 
 
 
 
 
Pre VR Experience Wellness Self-Assessment 
 
Please identify if you are currently experiencing any of the following  
and rate the degree of severity of the symptom(s) on a scale from 1 (mild) – 5 (severe): 
 
 
 
1. Headache: 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
2. Altered/Blurred/Double Vision:  
 
 
 
 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
3. Nausea: 
 
 
 
 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
4. Dizziness/Disorientation:  
 
 
 
 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
5. Fatigue: 
 
 
 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
 
 
 
 
Subject ID: 
 
Subject ID: 

 
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Post VR Experience Wellness Self-Assessment 
 
Please identify if you are currently experiencing any of the following  
and rate the degree of severity of the symptom(s) on a scale from 1 (mild) – 5 (severe): 
 
 
 
1. Headache: 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
2. Altered/Blurred/Double Vision:  
 
 
 
 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
3. Nausea: 
 
 
 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
4. Dizziness/Disorientation:  
 
 
 
 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
5. Fatigue: 
 
 
 
 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subject ID: 

 
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Retrospective VR Experience Wellness Self-Assessment 
 
Please identify if you recall any of the following within 24 hours after your VR 
experience and rate the degree of severity of the symptom(s) on a scale from  
1 (mild) – 5 (severe): 
 
 
 
1. Headache: 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
2. Altered/Blurred/Double Vision:  
 
 
 
 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
3. Nausea: 
 
 
 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
4. Dizziness/Disorientation:  
 
 
 
 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
5. Fatigue: 
 
 
 
 
☐ No  
☐ Yes 
 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
Appendix C – Preparedness Survey 
 
Please circle your level of agreement with the following statements: 
 
 

 
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1. 
I know about the reason for my planned procedure. 
 
Strongly Agree / Agree / Somewhat Agree / Somewhat Disagree / Disagree / Strongly Disagree 
 
 
2. 
I understand the purpose of my planned procedure. 
 
Strongly Agree / Agree / Somewhat Agree / Somewhat Disagree / Disagree / Strongly Disagree 
 
 
3. 
I understand the general activities around my planned procedure. 
 
Strongly Agree / Agree / Somewhat Agree / Somewhat Disagree / Disagree / Strongly Disagree 
 
 
4. 
I felt prepared about how and where to park my car. 
 
Strongly Agree / Agree / Somewhat Agree / Somewhat Disagree / Disagree / Strongly Disagree 
 
 
5. 
I felt prepared about how and where to register for my procedure. 
 
Strongly Agree / Agree / Somewhat Agree / Somewhat Disagree / Disagree / Strongly Disagree 
 
 
6. 
I felt prepared about how to find my way to my destination. 
 
Strongly Agree / Agree / Somewhat Agree / Somewhat Disagree / Disagree / Strongly Disagree 
 
 
7. 
I felt prepared about what to expect in the Prep/Recovery room. 
 
Strongly Agree / Agree / Somewhat Agree / Somewhat Disagree / Disagree / Strongly Disagree 
 
 
8. 
I felt prepared about what to expect in the procedure room. 
 
Strongly Agree / Agree / Somewhat Agree / Somewhat Disagree / Disagree / Strongly Disagree 
 
 
9. 
Overall, I felt prepared for what to expect at the Meijer Heart Center for my left heart catheterization 
procedure. 
 
Strongly Agree / Agree / Somewhat Agree / Somewhat Disagree / Disagree / Strongly Disagree 
 
 
10. Due to my preprocedure education by Spectrum Health, I sought out further information. 
 
Yes  No  If yes, please identify how ( e.g., used the internet, asked friends/family, called the office). 
 
 
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