Can Virtual Reality Reduce Patient's Pain, Improve Patient's Experience, and Reduce Procedure Related Anxiety With Venipuncture? A Randomized Control Trial
Phase: NA
Conditions: Procedural Anxiety, Procedural Pain
Sponsor: C.R.Darnall Army Medical Center

EIRB Protocol Template (Version 1.5)
1.0
General Information
*Please enter the full title of your study:
Can Virtual Reality Reduce Patient’s Pain, Improve Patient’s Experience, and Reduce Procedure 
Related Anxiety with Venipuncture? A Randomized Control Trial.
 
 
*Please enter the Protocol Number you would like to use to reference the protocol:
19-35
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify 
this protocol.
 
 
Is this a multi-site study (i.e. Each site has their own Principal Investigator)?
No
 
 
Does this protocol involve the use of animals?
Yes
No
 
 
2.0
Add Site(s)
2.1 List sites associated with this study:
Primary 
Dept?
Department Name
Army - Carl R. Darnall Army Medical Center (CRDAMC)
 
3.0
Assign project personnel access to the project
3.1 *Please add a Principal Investigator for the study:
 
Perdue, Matthew Jordan, MPAS
Select if applicable
Student
Site Chair
Resident
Fellow
 
3.2 If applicable, please select the Research Staff personnel:
 
A) Additional Investigators
B) Research Support Staff
G

3.3 *Please add a Protocol Contact:
 
Perdue, Matthew Jordan, MPAS 
The Protocol Contact(s) will receive all important system notifications along with the Principal 
Investigator. (i.e. The protocol contact(s) are typically either the Protocol Coordinator or the 
Principal Investigator themselves).
3.4 If applicable, please select the Designated Site Approval(s):
 
Add the name of the individual authorized to approve and sign off on this protocol from your Site 
(e.g. the Site Chair).
4.0
 
Project Information
4.1  * Has another IRB/HRPP reviewed this study or will another IRB/HRPP be reviewing this study?
If Yes, answer the questions according to the IRB/HRPP Determination.
  Yes   
  No
IRB Name
Review Date
Determination
No records have been added
4.2  * Is this a research study or a Compassionate Use/Emergency Use/HUD project?
 Yes   
 No
4.3  What type of research is this?
Biomedical Research
Clinical trial (FDA regulated)
Behavioral Research
Educational Research
Psychosocial Research
Oral History
Other
Describe other:
Investigational research
4.4  Are you conducting this project in pursuit of a personal degree?
 Yes   
 No
4.6  * Is this human subjects research? (As defined by 32 CFR 219) 
 
Human subject means a living individual about whom an investigator (whether professional or 
student) conducting research: 
   (i) Obtains information or biospecimens through intervention or interaction with the individual, 
and uses, studies, or analyzes the information or biospecimens; or 

  (ii) Obtains, uses, studies, analyzes or generates identifiable private information or identifiable 
biospecimens.  
 Yes   
 No
4.7  * Do you believe this human subjects research is exempt from IRB review?
  Yes   
  No
5.0
 
Personnel Details
5.1  List any Research Team members without EIRB access that are not previously entered in the 
protocol:
Name:
(Last, First, M.I.)
Miklovic, Tyler
Role on Protocol:
Assistant investigator
Phone Number:
 
571-426-0876
Email Address:
 
tyler.miklovic@gmail.
com
Associated Institution:
 
CRDAMC
Name:
(Last, First, M.I.)
Phillips, Eric
Role on Protocol:
Assistant investigator
Phone Number:
 
518-593-1715
Email Address:
 
e_phlips@yahoo.com
Associated Institution:
 
CRDAMC
Name:
(Last, First, M.I.)
Farley, Loyal S.
Role on Protocol:
Assistant investigator
Phone Number:
 
801-473-3347
Email Address:
 
l.shane.farley@gmail.
com
Associated Institution:
 
CRDAMC
Name:
(Last, First, M.I.)
Walker, Jerimiah D.
Role on Protocol:
Assistant Investigator
/Mentor
Phone Number:
 
210-380-2670
Email Address:
 
jerimiah.d.walker.
mil@mail.mil
Associated Institution:
 
CRDAMC
5.2  
Will you have a Research Monitor for this study?
Yes 
No 
N/A 

6.0
 
Data/Specimens
6.1  Does the study involve the use of existing data or specimens only (no interaction with human 
subjects)?
  Yes   
  No
7.0
 
Funding and Disclosures
7.1  Source of Funding:
Funding Source
Funding Type
Amount
No records have been added
Total amount of funding:
7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
  Yes   
  No
If Yes, complete and attach Conflict of Interest forms for all key personnel
8.0
 
Study Locations
8.1  Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
  Yes   
  No
8.2  Study Facilities and Locations:
Institution
Site 
Name
Site Role
FWA or 
DoD 
Assurance 
Number
Assurance 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing 
for Site
No records have been added
Other:
Other 
Institution 
Site
Site Role
FWA or DoD 
Assurance 
Number
FWA or DoD 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing 
for Site
No records have been added
8.3  Are there international sites?

Attach international approval documents, if applicable, when prompted. Note: Ensure local research 
context has been considered
  Yes   
  No
8.4  Is this an OCONUS (Outside Continental United States) study?
  Yes   
  No
Select  the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to study 
approval)
  Yes   
  No
9.0
 
Study Details
9.1  Key Words:
Provide up to 5 key words that identify the broad topic(s) of your study
virtual reality, pain control, procedure related anxiety, distraction
9.2  Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the protocol.  The 
background section should clearly support the choice of study variables and explain the basis for the 
research questions and/or study hypotheses.  This section establishes the relevance of the study and 
explains the applicability of its findings
The use of distraction with media devices to assist in pain control has progressed in leaps and bounds in 
the last 15 years. Methods of distraction include, but are not limited to, video games, IPads, television, 
Augmented Reality, Virtual Reality (VR), cognitive behavioral therapy, and hypnosis. As reported by 
Mahrer and Gold, Virtual Reality has been studied with success in the treatment of burn patients 
undergoing physical therapy in multiple studies pitting VR against standard analgesia, video games, 
audio recordings, and cognitive behavioral therapy. Virtual Reality has also been successfully tested by 
Nilsson et al. in pediatric cancer patients receiving chemotherapy. They report a significant reduction in 
pain and distress during placement of subcutaneous venous port access. Furman et al. showed improved 
pain scores during dental procedures while watching movies. Additionally, there have been two studies 
on routine procedures by Gold et al. who investigated blood draws and intravenous placement of contrast 
for MRI scans in pediatric patients, both of which showed improved pain and anxiety scores.  A recent 
randomized controlled trial by 
et al. showed reduced pain, fear and anxiety in pediatric 
Özalp Gerçeker 
patients undergoing blood draws when using VR devices, including a group which used the Ocean Rift 
application.
 
The technology relating specifically to Virtual Reality has seen significant changes in the last 5 
years.  Previously, Virtual Reality devices required either a direct connection to a local computer or even 
a dedicated system to run them. New to the market in the last few years are devices which do not 
require a connection to a computer, phone, or internet for some functions. This is significant as these 
devices can be used in any environment with minimal equipment.
Additionally, Malloy and Milling report that the use of more sophisticated technology with improved 
immersion is associated with even greater relief of pain. Although there are alternative methods for 
anxiety and pain control in the emergency setting, the use of immersive virtual reality (virtual reality 
methods in which the user is able to interact with the virtual environment) with these new standalone 
devices may improve pain control and anxiety associated with procedures, decreasing the need to use 
anxiolytics, opioids, and anesthetics in the emergency department. If a significant difference is found 
between the standard practice of performing venipuncture without pain control or virtual reality and the 
standard practice with the addition of virtual reality, then there would be strong implications to utilize the 
method in the emergency department setting.   This could lead to future studies on additional procedures 

with VR such as laceration repair, nail trephination, digital blocks, nail removal, lumbar punctures, and 
incision and drainage of abscesses.
In order to support the hypothesis of this study, which is that there will be a clinically significant 
decrease in pain perception when patients use virtual reality devices during venipuncture, a literature 
review was conducted focusing on articles published from 2000 to present using key terms virtual reality, 
and 
 
. The review was conducted on databases such as 
pain control, distraction, 
procedure related anxiety
Pubmed, Ovid, Cochrane, Medline, Google Scholar, and a hand search through references used in 
applicable articles. A total of 60 articles were reviewed for relevance. Of the 60 reviewed articles, 23 
were selected for their relevance to the research question. The literature review shows no studies of note 
have been conducted which would be applicable to an adult population for similar procedures (ie. 
venipuncture).
 
Given the lack of research on the use of VR with common procedures such as IV access in an adult 
population, it remains unclear whether the use of VR would be beneficial in this population, or if the 
benefits are limited only to pediatric patients. If the results of this study show significant improved pain 
and anxiety levels in adults, thus rejecting the null hypothesis (which is that there will be no significant 
difference in pain or anxiety with and without the use of virtual reality), it would be reasonable to initiate 
further research into the use of VR for other common procedures performed in the emergency 
department, laboratory, family practice, or in the military setting while deployed.
9.3  
Objectives/Specific Aims/Research Questions:
Describe the purpose and objective(s) of the study, specific aims, and/or research questions/hypotheses
The study's primary outcome is to determine if the use of immersive virtual reality with the Oculus Go 
improves the patient’s pain ratings and pain intensity levels when undergoing venipuncture during 
routine blood draws versus the standard practice. We will use the Visual Analogue Scale (VAS) for pain 
assessment after each blood draw.
The study's secondary outcome is to assess procedure related anxiety before and after each intervention, 
which will also be measured with the VAS. We will also use the Likert scale to measure participant 
satisfaction with the procedure and whether or not they would request the use of VR again if available.
9.4  Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, cohort, etc.). 
Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug research
This study is a prospective randomized controlled trial comparing the standard practice for venipuncture 
to the standard practice with the addition of Virtual Reality. In order to test our hypothesis, we will be 
conducting this study in the phlebotomy lab on patients aged 18-50 years old who are already 
undergoing venipuncture for routine lab testing.
The study will test the participant’s acute pain level associated with the procedure, as well as testing 
their level of procedure-related anxiety before and after the procedure.
9.5  Target Population:
Describe the population to whom the study findings will be generalized
Adults over the age of 18 who are undergoing venipuncture for routine purposes. We expect the results 
to be generalizable to the full Military population as well as Civilians of the same age with similar 
concerns about pain or anxiety related to the procedure.
9.6  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
The use of distraction with media devices to assist in pain control could have significant benefit to the 
DoD, particularly in the acute pain setting, to include the emergency setting, and Soldiers in the 
deployed setting. In the emergency setting, the use of VR could significantly improve patients’ overall 

experience and satisfaction with their visit, as well as reducing their pain and anxiety associated with 
having minor procedures performed. As noted by Fields el al. having an IV started is the most painful 
procedure performed during many patients emergency department visit. Given an improved patient 
experience, the use of VR could improve overall patient satisfaction scores on post visit surveys as well. 
Separately, but of equal importance, the use of standalone, immersive virtual reality could significantly 
benefit Soldiers in the Deployed setting. In the deployed setting, supplies for patient care can be variably 
available, to include adequate amounts of medications such as anxiolytics, opioids, and anesthetics. This 
is also applicable to large-scale training events such as NTC or JRTC where supplies for pain control may 
be even scarcer. A single VR unit does not expire, is reusable, and can be purchased for less than $200. 
If the results of this study show improved pain scores, it would be reasonable in a deployed/training 
environment setting to use the device as an adjunct to pain control and patient care in order to improve 
Soldiers treatment.
10.0
 
Study Procedures, Data Management, and Privacy
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
A prospective randomized controlled trial comparing standard practice for conducting venipuncture to 
standard practice with the addition of Virtual Reality using the Oculus Go Head Mounted Display 
(HMD). The study will be performed on volunteers who are reporting to the
lab to have 
 phlebotomy 
venipuncture for blood draws that were previously ordered by their health care providers. 
Participants who were not already scheduled to undergo routine venipuncture will
be included.
 not 
 
When approaching the ticket stand to draw a waiting number for the lab, prospective participants will be 
asked by an assistant investigator located near the kiosk if they are interested in participating in the 
study. If the participants express interest, they will be directed to the screening station. The screening 
station will be set up in a private room near the lab waiting area, and participants will be screened for 
eligibility and educated on the benefits and risks of the study. They will also provide informed consent if 
they decide to participate.
 
All participants will be asked to fill out a self-reported data questionnaire in addition to the informed 
consent document to assess for inclusion and exclusion criteria discussed later in this protocol.  This 
questionnaire will assess the participant's expected level of anxiety prior to the procedure and 
expected level of pain associated with the procedure by utilizing a visual analog scale (VAS).  The VAS 
will be on a 100 millimeter line similar to the one shown below:
 
 
 
Once approved for participation in the study all participants will undergo a brief instructional class on 
how to operate the HMD and will be allowed sufficient time to become comfortable with its use. We 
expect approximately 5-10 minutes to be required for this portion of the study. Once familiar with the 
use of the VR headset, participants will be asked to randomly draw an envelope from a 
container.  This envelope will contain a block and sequence number.  The block and sequence number 
will be the subject ID and will correspond to a predetermined number set on a separate 
document that will determine if the participant will use the HMD during venipuncture or not.  The 
screener will not have immediate access to the list showing which group the participant will be 
assigned to.  One member of the study team will be present in the lab room to ensure the participant 
uses the VR headset (or not) according to what is randomly drawn. This member of the research 
team will have the list showing whether or not the participant is assigned to the control arm or the 
experimental arm.  The participants will then proceed to the specimen room to undergo venipuncture.
 
Venipuncture for both groups will be occur in the non-dominant arm. The reasoning for this is that 
the Oculus Go requires one free hand to use a controller. This will ensure that the individuals 
participating are able to effectively use the device.  Those unable to undergo venipuncture in the non-

dominant arm will undergo venipuncture in the dominant arm instead and will use the Oculus Go 
controller with their non-dominant hand.
 
Those utilizing the Oculus Go HMD will be interacting with the VR game Ocean Rift. They will utilize a 
single controller to explore an underwater safari park. Ocean Rift has multiple environments to 
choose from, including coral reefs, ship wrecks, lagoons, the arctic, and prehistoric seas. Participants 
may interact with and and learn about different creatures to include dolphins, turtles, orcas, ray, 
whales, sea lions, manatees, and dinosaurs. During the game users may travel where they please 
and interact with what they choose. The VR device is equipped with head-tracking software that 
allows the user to choose direction by looking around. The entire interior and exterior of the headset 
will be cleaned with alcohol-based wipes after each use.  Alcohol will be used since it is generally well-
tolerated on human skin, and since it evaporates quickly.  The headset will be dried in the open air 
for a minimum of two minutes between each subject's use.
 
Those not using the VR will still wear a headset that will simply be turned off.  This is to ensure that 
any significant change noted with the VR is due to the use of VR itself, and not simply due to 
"blindfolding" the patient during the procedure.
 
As some patients experiencing anxiety may be tempted to move during the procedure, lab personnel will 
isntruct participants to remain still during venipuncture.  Participants will be advised that they may take 
breaks as needed if anxiety becomes overwhelming.
 
After undergoing the procedure, each participant will be asked to fill out the post-
procedure questionnaire and return it to the study team member present in the lab room, who 
will clean the headset as the participant completes the questionnaire. This questionnaire assesses 
the patient’s pain intensity and level of anxiety with the VAS similar to the VAS shown above, as well 
as the patient’s satisfaction with the visit which will be measured utilizing a Likert scale for individual 
questions (see below).
 
 
10.2  Data Collection:
Describe all the data variables, information to be collected, the source of the data, and how the data will 
be operationally measured.
The independent variable for this study is the use of VR or lack thereof. The dependent variables include 
accurately measuring anxiety levels pre and post procedure, pain levels after the procedure, and 
satisfaction with the procedure in regards to pain control, anxiety management, and ease of use.
The participant’s gender, age, and a minimal medical history will be obtained for purposes of inclusion or 
exclusion from the study. The information collected relevant to the conduct of the study will include any 
history of bloodborne disease, anxiety, seizures, pregnancy status, right vs left handedness, VR 
experience, nausea, vomiting, or vertigo. Participants will also be asked to rate their expected pain and 
anxiety associated with venipuncture using the Visual Analog Scale (VAS). The above information will be 
collected on the self-reported data sheet prior to providing specimens. The questionnaires will also 
enquire as to whether the participant took any pain medications prior to arrival, as well as rate pre and 
post-procedure anxiety level on a VAS scale.  Finally, patients will then rate their procedure related pain 
intensity on the VAS scale.
Participants will also be asked about their satisfaction level with the use of VR in regards to pain control, 
anxiety management, and ease of use and their likelihood of requesting VR if available in the future 
using the Likert scale. All information will be provided and data collected voluntarily, and participants 
may choose not to answer any questions they choose.
The VAS will be measured using a 100 millimeter line on which the participant will be instructed to place 
a mark corresponding to their pain or anxiety, i.e. 5 would be very little anxiety and 95 would be very 
high anxiety. The data will then be acquired using a metric ruler and the corresponding number will be 
documented. The Likert scale will be measured using a one to five numeric scale on which the patient will 
be asked to rate their satisfaction with the use of the VR headset in regards to pain control, anxiety 
management, and ease of use, and their likelihood of requesting its use again, 1 being very unlikely, 2 
likely, 3 unsure, 4 likely and 5 very likely.

10.3  At any point in the study, will you request, use, or access health information in any form, including 
verbal, hard copy and electronic?
  Yes   
  No
11.0
 
Statistical/Data Analysis Plan
11.1  Statistical Considerations:
List the statistical methods to be used to address the primary and secondary objectives, specific aims, 
and/or research hypotheses.  Explain how missing data and outliers will be handled in the analysis.  The 
analysis plan should be consistent with the study objectives.  Include any sub-group analyses (e.g., 
gender or age group).  Specify statistical methods and variables for each analysis.  Describe how 
confounding variables will be controlled in the data analysis
The Primary outcome for this study is the measure of perceived  pain intensity with and without the use 
of the VR headset. The outcome will be measured with the VAS scale for pain which will be completed 
immediately after each procedure. The VAS will be measured as a 100 mm line on which the participant 
will be instructed to make a mark corresponding to their level of pain. The mark will then be measured 
with a metric ruler and the appropriate number documented.
 
A 13 mm change is the minimum clinically significant difference that is noticeable by patients according 
to a study by Gallagher et al 2001. The null hypothesis in this study is that the average pain 
intensity between groups will be not be clinically significant, which is defined as 13mm. 
 
The primary statistical method will be to measure the mean perceived pain between groups 
using the VAS. The t-test will be used to determine if the effect size between the two groups is 
statistically significant as this is a study with a dichotomous predictor variable (with or without VR) but a 
continuous outcome variable (pain measurement on the VAS).
 
Additional outcomes to include satisfaction with the procedure and likelihood of requesting VR again if it 
is available will be measured using the Likert scale. It will be measured on a one to five scale. Results of 
the Likert scales will be reported as is.  Likert scale questions are as follows:
 
As this study will utilize and Intention to Treat (ITT) methodology, all enrolled subjects will be included in 
the final data analysis.
11.2  Sample Size:
60
11.3  Total number of subjects requested (including records and specimens):
60
11.4  

If you are recruiting by study arm, please identify the arms of the study and how many subjects will 
be enrolled in each arm
Control (standard of care) - 30
Experimental (standard of care plus virtual reality) - 30
11.5  Please provide a justification for your sample size
A study performed by Todd et al 1995 and a later validation study by Gallagher et al 2001 both found 
that a minimum clinically significant change in pain as measured on the VAS is 13mm.  Both studies 
found that the change in pain reported as "a little more pain" or "a little less pain" after intervention 
averaged to 13mm.  Both studies also found that the standard deviation of change in pain reported on 
the VAS as "a little more pain" or "a little less pain" was 17mm.
 
Since the t-test will be used at the end of the study to determine if the effects are statistically significant, 
the E/S ratio (expected effect size divided by the standard deviation of the outcome variable) was used 
to determine the sample size.  The E/S ratio is being estimated based on the studies cited above.  The 
expected effect size (13mm) divided by the standard deviation (17mm) =0.76.  To ensure a 2-sided α 
0.05 and β 0.20, a minimum of 27 subjects are required for each arm.  This is based on a sample size 
calculator created by Dhand et al as well as appendix 6A of 
authored by 
Designing Clinical Research 
Hulley et al.
 
Although a total of only 54 participants is required for this study to be effectively powered, we're 
requesting 60 to account for a potential dropout rate of 10%.
 
Minitab software will be utilized for final data analysis.
11.6  Data Analysis Plan: Complete description: Background, Objectives, Design, Step by Step how the 
project is going to be done, Data analysis plan:
The primary outcome be measured as the average pain rating between the two groups as measured on 
the VAS.  The t-test will be used to compare the two groups to determine if the difference is statistically 
significant.  The difference between the two groups should be at least 13mm to be considered clinically 
significant.
 
The preprocedural anxiety will also be measued using the VAS and the average difference will be 
reported in the data, although a minimum clinically significant score is not available.
 
Since participants will be randomly assigned to each study arm, it will be impossible to insure an even 
spread of ages between the two study arms.  It may be possible that pain perception changes with age, 
and since this study will include ages 18-50, data tables comparing the average changes between those 
in different age groups (i.e. 18-25, 26-33, 34-41, 42-50).  A separate subgroup analysis will be 
performed comparing different age subgroups.
 
Similar data analysis will be included for pre-procedural anxiety.
 
Likert scale questions ("Overall, how satisfied were you with the use of Virtual Reality?" and "How likely 
would you be to request Virtual Reality if it were available for use?") will be reported in the final 
manuscript.
12.0
 
Participant Information
12.1  Subject Population:
Adults aged 18-50 who meet inclusion criteria and are already scheduled to undergo venipuncture.  Most 
will be active duty Soldiers, Family members, DA civilians, and retirees.  No compensation will be 
provided for participating.
12.2  Age Range:

Check all the boxes that apply. if the age range of potential subjects (specimens, records) does not 
match the range(s) selected, please specify in the text box.
0-17
18-24
25-34
35-44
45-54
55-64
65-74
75+
18-50
12.3  Gender:
Male
Female
Other
12.4  Special categories, check all that apply
Minors /Children
Students
Employees - Civilian
Employees - Contractor
Resident/trainee
Cadets /Midshipmen
Active Duty Military Personnel
Wounded Warriors
Economically Disadvantaged Persons
Educationally Disadvantaged Persons
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity
Prisoners
Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
12.5  Inclusion Criteria:
Order 
Number
Criteria
1 
Adults aged 18-50
 
2 
Currently scheduled to undergo venipuncture
 
12.6  Exclusion Criteria:
Order 
Number
Criteria
Less than 18 years old or greater than 50 years old

1 
 
2 
History of motion sickness (nausea or vertigo)
 
3 
Pregnant women
 
4 
Reported history of blood borne disease (no request will be made for which disease
participant has)
 
5 
Use of pain medication(s) on day of study
 
6 
Current use of medical devices, including hearing aids, pacemakers, implanted cardiac 
defibrillators
 
7 
Currently experiencing headache/migraine
 
13.0
 
Recruitment and Consent
13.1  Please describe the recruitment process, including how subjects will be identified and selected for 
the study.
When approaching the ticket stand to draw a waiting number for the lab, prospective participants will be 
asked by an assistant investigator located near the kiosk if they are interested in participating in the 
study.  Participants will be selected in consecutive order (as long as the screening room is open) to avoid 
selection bias.  However, patients who are obviously outside of the age range of 18-50 will not be asked 
to participate, although this process may leave room for some selction bias.  If participants express 
desire, they will move to a screening station located in a private room near the lab to be educated on the 
details of the study, to include any risks.  If they consent, they willl fill out a screening questionnaire.  If 
patients are eligible, they’ll be given a brief tutorial on use of the VR headset and randomly assigned an 
envelope containing a card stating that they willl use VR during venipuncture or undergo standard 
practice (the researcher will be blind to which group the participant is assigned to).  Once instruction is 
complete, they’ll return to the lab waiting area to draw a ticket to provide a specimen IAW standard lab 
practice.
13.2  Compensation for Participation:
There will not be any compensation (payment or otherwise) for participating in this study.
13.3  Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text 
editor
When patients approach the ticket kiosk, a member of the study team will ask them if they're interested 
in participating in a study related to pain control with venipuncture. To avoid perceived coercion, the 
recruiter will be in scrubs so that his rank will not be visible. If the participants wish to participate, they'll 
be directed to a screening station in a private room.
 
At the screening station, candidates will be screened to insure they meet inclusion/exclusion criteria by 
completing a prescreening form that addresses all participation criteria.  After that, they'll be provided 
informed consent documents and will undergo a brief tutorial for use of the VR headset prior to returning 
to the lab waiting area to draw a ticket.
13.4  Consent Process:
 
Revised Common Rule, Section 219.116:  General requirements for informed consent, whether 
written or oral, are set forth in this paragraph and apply to consent obtained in accordance with the 
requirements set forth in paragraphs (b) through (d) of this section. Broad consent may be 
obtained in lieu of informed consent obtained in accordance with paragraphs (b) and (c) of this 

section only with respect to the storage, maintenance, and secondary research uses of identifiable 
private information and identifiable biospecimens.
Are you requesting a waiver or alteration of informed consent?
  Yes   
  No
Please explain the consent process:
The consent process will take place at the time of recruitment, and will occur in a private room with only 
the subject and investigator present. Participants will be walked through the informed consent document 
section by section, being allowed time to read each section and decide if they would like to continue. 
Participants will be informed prior to starting that participation is voluntary and that they may choose not 
to participate at any time during the consent process, throughout the duration of the study, and after it 
is complete. They will be informed on the process to withdraw from the study which will be to contact 
CPT Perdue at the above listed email or phone number which will be on the consent form and pointed out 
to the participant. Once complete the participant will be asked to sign the consent document and the PI 
will sign the consent form.  Copies of the signed consent form will be made and provided to the 
participant. Participants will also be asked to fill out the Self-reported participant data form for inclusion
/exclusion from the study and will be informed prior to leaving whether they are eligible to participate. 
All questions will be answered by the PI or AI at any point during participant contact or via email or 
phone.
13.5  DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman.
N/A 
Propose ombudsman 
13.6  Withdrawal from Study Participation:
Explain the process for withdrawal and specify whether or not the subjects will be given the opportunity 
to withdraw their data their data/specimens in the event they wish to withdraw from the study
 
The decision to participate in this study is completely voluntary. No one will be coerced or intimidated 
into participating in this project. The principal investigator or his associate investigator will adequately 
answer any and all questions about this study, participation, and the procedures involved. If significant 
new findings develop during the course of this study that may relate to participant participation, they will 
be informed.
 
Subjects may withdraw this consent at any time and discontinue further participation in this study 
without affecting eligibility for care or any other benefits to which they are entitled. Should participants 
choose to withdraw, they must simply inform CPT Perdue that they have no desire to continue during 
their visit at the lab.  As no PHI will be collected and subjects will be unidentifiable after completing 
questionnaires, participants will be unable to withdraw after completing all questionnaires.
14.0
 
Risks and Benefits
14.1  
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study.  Consider the risks of breach of 
confidentiality, psychological, legal, social, and economic risks as well as physical risks.  Do not describe 
risks from standard care procedures; only describe risks from procedures done for research purposes

Risk associated with this study may include dizziness, loss of awareness, eye strain, temporary visual 
abnormalities (including blurred or double-vision), muscle-twitching, impairment of hand-eye 
coordination, impaired balance, excessive sweating, drowsiness, fatigue, headache, lightheadedness, 
disorientation, nausea and/or vomiting from the use of the VR device, although the frequency of these 
events is rare not well-defined.  Approximately 1 in 4,000 users may experience seizures despite having 
no history of seizure disorders; seizures are more common in children (who are excluded from this 
study).  Risk of experiencing adverse events may be increased if patients have a history of seizure 
disorders, or if they have other underlying neurological disorders.  Risk may also be increased if with the 
use of certain medications, although this data has not been studied.
 
There is also risk associated with accidental movement of arm during venipuncture, which could result in 
mistakenly puncturing unintended an area of the patients skin.  However, this is unlikely as standard 
practice when drawing blood is for the phlebotomist to steady the patient's arm 
and draw skin taught with the hand not holding the needle, minimizing the likelihood that the patient will 
move.
 
There is also a risk in loss of subject confidentiality, which is addressed in section 14.2.
14.2  
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate risk of 
harms to subjects and study personnel
Risks associated with the use of VR will be mitigated by screening for and excluding patients with a 
recent history of vertigo or dizziness, motion sickness, current symptoms of nausea and/or vomiting, and 
pregnancy.  Additionally, in an effort to minimize risk, the following instructions will be provided during 
the tutorial:
 
If you begin to experience nausea, headache, eye strain, or any other discomfort, please remove 
the headset and inform a member of the research team immediately
Participants will also be advised to request breaks as needed if they experience uncontrollable anxiety, or 
they may withdraw if they request as stated in the consent form.
To minimize the risk of patients moving arms during venipuncture, phlebotomists will be asked to alert 
the patient that they are about to penetrate the skin and to hold still.
To minimize the risk of loss of confidentiality, all information collected will be controlled with strict record 
keeping procedures.  All de-identified data collected will be stored in a locked drawer behind a locked 
door when not in use and only accessible to the research team members. Once gathered, the data will be 
transferred into electronic form on a secure CAC-enabled/password protected government computer that 
will be in the possession of the PI, when not in the PI's possession it will be stored in a locked room. The 
electronic documents will be kept for 3 years and then deleted. There will be no legal or economic risks 
associated with this study. No adverse action will be taken against anyone who withdrawals from the 
study at any time.
14.3  
Confidentiality Protections (for research records, data and/or specimens):
Describe in detail the plan to maintain confidentiality of the research data, specimens, and records 
throughout the study and at its conclusion (e.g., destruction, long term storage, or banking). Explain the 
plan for securing the data (e.g., use of passwords, encryption, secure servers, firewalls, and other 
appropriate methods). If data will be shared electronically with other team members/collaborators 
outside the institution, describe the method of transmission and safeguards to maintain confidentiality. 
Explain whether this study may collect information that State or Federal law requires to be reported to 
other officials or ethically requires action, e.g., child or spouse abuse
All de-identified data collected will be stored in a locked drawer behind a locked door when not in use 
and only accessible to the research team members. Once gathered, the data will be transferred into 
electronic form on a secure CAC-enabled/password protected government computer that will be in the 

possession of the PI. When not in the PI’s possession it will be secured in a locked office. The de-
identified electronic data will be stored on the attached Excel spreadsheet. Paper copies will be shredded 
once data has been transferred. Once the study is complete the electronic documents will be maintained 
on the primary investigator's CAC-enabled/password protected government computer until the computer 
is turned in upon PCSing and then deleted.
14.4  
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits to a 
specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and they 
cannot provide their own consent, the protocol must describe the intent to directly benefit all subjects
The subjects in the experimental group will potentially benefit from this study via reduction in anxiety 
and pain control, but will not directly benefit from this study in any other way. If Virtual Reality is shown 
to decrease pain intensity and anxiety levels with venipuncture, it may be offered in the lab setting, clinic 
setting, emergency room setting, or deployed setting to improve the care that can be provided.
14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and all 
research activities, etc.
During the screening process no PHI will be collected. The participant's name and signature will be on the 
consent form, but will not be linked to any PHI.  The screening questionnaire will contain age and 
gender, and will ask several questions about health, but will not be linked to the consent form and 
therefore will not contain PHI. This will be performed in a private room with only the member of the 
study team collecting the data present.  Once gathered, the data will be stored in electronic form on a 
secure CAC-enabled/password protected government computer that will be in the possession of the PI. 
After paper documents are transferred electronically they will be shredded, the electronic documents will 
be kept for 3 years and then deleted.
14.6  
Incidental or Unexpected Findings:
Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject’s participation in the research. In cases where the subject could 
possibly benefit medically or otherwise from the information, state whether or not the results of 
screening, research participation, research tests, etc., will be shared with subjects or their primary care 
provider. State whether the researcher is obligated or mandated to report results to appropriate military 
or civilian authorities and explain the potential impact on the subject
Incidental findings are unlikley given the procedures in this study.  However, should one arise and the 
subject could possibly benefit from the information, they will be informed.
15.0
 
Study Monitoring
15.1  Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring 
Board (DSMB).

DSMP 
DSMB 
Both 
Not Applicable 
16.0
 
Reportable Events
16.1  Reportable Events: Consult with the research office at your institution to ensure requirements are 
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the protocol or consent 
form are needed and the scale that will be used to grade the severity of the adverse event. 
Consult with the research office at your institution to ensure requirements are met
 
• Describe plans for reporting expected adverse events. Identify what the expected adverse events will 
be for this study, describe the likelihood (frequency, severity, reversibility, short-term management and 
any long-term implications of each expected event)
 
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address how 
unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or consent 
form are needed and the scale that will be used to grade the severity of the adverse event
Expected possible adverse events for this study are as follows:
Headache
Dizziness
Eye strain
Blurred vision
Muscle twitching
Eye strain
Disorientation
Excessive sweating
Loss of balance
 
The incidence of these events are not well-defined, so it's difficult to estimate the likelihood of these 
events occuring.  However, participants will be instructed to discontinue the use of the headset if any of 
these symptoms, or any other discomfort occurs. If participants experience any of these symptoms and 
discontinue the use of the device, they will be monitored briefly by the research investigators as these 
symptoms should resolve spontaneously and should not have long-term implications.  If symptoms do 
not resolve within 10-15 minutes, they will be escorted to the emergency room for further evaluation.
 
Expected adverse events will be reported by the principal investigator in the same fashion as 
unanticipated problems (stated below).  As data collection is only expected to occur for 3-4 days, 
investigational staff will be reviewed after each adverse event to determine if changes need to be made 
to the research protocol or consent form.
 
The only known unanticipated problem involving risk to subject or others (UPIRSO) is seizure.  As stated 
in the Oculus Go user manual, this has an incidence of approximately 1 in 4,000 users, although it most 
commonly occurs in children (who are excluded from the study).  In the event that this occurs, subjects 
will have all sharp objects moved away from them, be placed laterally on their sides, and emergency 
personnel will be contacted for transport to the ER for further evaluation and treatment.
 
Unanticipated problems involving risk to subjects or others will be reported promptly providing initial 
notification of the event as quickly as possible after the research team’s knowledge of the event, but 
within (5) business days of identification by phone (210-916-2598), by e-mail (usarmy.jbsa.medcom-
bamc.mbx.bamc-irb@mail.mil), or by facsimile (210-916-1650) to the Office of the Regional Health 
Command Central (RHC-C) Institutional Review Board (IRB). A complete written report will follow the 
initial notification within ten (10) business days. The complete report will be sent to the RHC-C IRB Office 
I, Brooke Army Medical Center, ATTN: MCHE-ZQ, Department of Quality and Safety, 3551 Roger Brooke 
Drive, Fort Sam Houston, Texas 78234-6315.
 
To fulfill the local responsibility for monitoring and oversight of research, all potential UADEs that are 
unexpected and determined to be at least possibly related or definitely related to research participation 

will be promptly reported within 24 hours of learning of the event by telephone or by email to the local 
IRB Office. A complete report will follow the initial notification within 5 business days.
17.0
 
Equipment/non-FDA Regulated Devices
17.1  Does the study involve the use of any unique non-medical devices/equipment?
 Yes   
 No
Please describe:
An Oculus Go head mounted display (HMD) will be used to display the virtual environment. The HMD has 
a 3-point adjustable harness which is used to hold the display in place on the wearer’s head. The HMD is 
not a medical device. Side effects using virtual reality systems include occasional reports of transient 
nausea, dizziness and headache.
 
There are no reports of long-term side effects associated with using virtual reality equipment.
 
The Oculus Go head mounted display does not meet the definition of a Significant Risk device, thus this 
study is considered a Non-significant Risk Device Study. We make this determination in accordance with 
the Significant Risk Device Study definition under 21 CFR 812.3(m) as part of the Investigational Device 
Exemptions (IDE) regulation (21 CFR 812).
Specifically, this device and its components:
1) are not implantable devices;
2) are not purported nor represented to be used to support or sustain human life;
3) are not used to diagnose, cure, mitigate, or treat a disease or otherwise prevent impairment of human 
health;
4) do not present a potential for serious risk to the health, safety, or welfare of a subject.
They will be labeled “experimental” for this study.
18.0
 
FDA-Regulated Products
18.1  Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A
18.3  Device Details:
Are device(s) in this research being used in accordance to the approved labeling?
Are device(s) in this research being used in a manner other than its approved labeling?
When adding a device indicate in the details section of the device if the use is either used in accordance 
to the approved labeling or in a manner other than it's approved labeling
View Details
Device Name
Oculus Go 
Manufacturer/Supplier of Device
Oculus VR, LLC 
Where will the Devices Be Stored
In office at Darnall ED 
Will Devices be supplied at no 
Cost
Yes 

Is this a HUD (HDE)
No 
HDE Number
 
Who holds the IDE
N/A  
IDE details
IAW CFR 812.2(b) device meets abbreviated requirements. 
Device will be labeled with “CAUTION-Investigational device. 
Limited by Federal law to investigational use.”  
Oculus Go 
Manufacturer/Supplier of Device
Oculus VR, LLC 
Where will the Devices Be Stored
Office at Darnall ED 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Who holds the IDE
N/A  
IDE details
IAW CFR 812.2(b) device meets abbreviated requirements. 
Device will be labeled with “CAUTION-Investigational device. 
Limited by Federal law to investigational use.”  
Oculus Go 
Manufacturer/Supplier of Device
Oculus VR, LLC 
Where will the Devices Be Stored
Office at Darnall ED 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Who holds the IDE
N/A  
IDE details
IAW CFR 812.2(b) device meets abbreviated requirements. 
Device will be labeled with “CAUTION-Investigational device. 
Limited by Federal law to investigational use.”  
Oculus Go 
Manufacturer/Supplier of Device
Oculus VR, LLC 
Where will the Devices Be Stored
Office at Darnall ED 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Who holds the IDE
N/A  
IDE details
IAW CFR 812.2(b) device meets abbreviated requirements. 
Device will be labeled with “CAUTION-Investigational device. 
Limited by Federal law to investigational use.”  
18.4  Reporting Requirements for FDA-regulated research under IND and IDE:
Describe the process for complying with FDA regulatory requirements for adverse event reporting and 
adverse device effects reporting to the sponsor
The Oculus Go is an investigational device that poses a non-significant risk to the participant and is not 
being marketed as a medical device. The device does not pose a significant risk as it is not intended to 

be implanted, used to sustain/support life, used for diagnosis or treatment, or present any other 
potential for serious risk to health.
18.5  Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
19.0
 
Research Registration Requirements
19.1  ClinicalTrials.gov Registration:
Registration is not required 
Registration pending 
Registration complete 
19.2  Defense Technical Information Center Registration (Optional):
Registration is not required 
Registration pending 
Registration complete 
20.0
 
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20.2  Abbreviations and Acronyms:
VR - Virtual Reality
HMD - Head Mounted Display
IV - Intravenous
CRDAMC - Carl R. Darnall Army Medical Center
ED - Emergency Department
VAS - Visual Analogue Scale
I&D - Incision and Drainage