Evaluating the Feasibility of Virtual Reality for Procedural Sedation in Pediatric Renal Biopsy Patients
Phase: NA
Conditions: Pain, Procedural, Procedural Anxiety, Sedation Complication
Sponsor: University of California, San Francisco

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Cover Page for ClinicalTrials.gov 
 
Document:  
Study protocol with statistical analysis plan 
 
Official Study Title: 
Evaluating the Feasibility of VR for Pediatric Renal Biopsies 
 
NCT Number: 
NCT05267704 
 
Original Document Date:  
October 9, 2021 

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UCSF Department of Anesthesiology 
Virtual Reality (VR) for Pediatric Renal Biopsy 
Clinical Research Protocol 
 
Protocol Number: 
IRB#21-35095 
Version Date: 
10/9/2021 
Sponsor: 
UCSF Department of Anesthesiology 
Funding Organization: 
UCSF Department of Anesthesiology 
Principal Investigator: 
Name: Justin Libaw, MD, MPH 
Telephone: 415- 443-1366 
 
E-mail: justin.libaw@ucsf.edu 
Co-Principal 
Investigator/Study 
Contact: 
Name: Omar Salman, MD 
Telephone: 415-514-1815 
E-mail: omar.salman@ucsf.edu 
 
Approval: 
 
 
 
PI or Sponsor Signature (Name and Title)  
 
Date 
This confidential information about an investigational product is provided for the exclusive use of 
investigators of this product and is subject to recall at any time.  The information in this document 
may not be disclosed unless federal or state law or regulations require such disclosure.  Subject to the 
foregoing, this information may be disclosed only to those persons involved in the study who have a 
need to know, with the obligation not to further disseminate this information.   

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PROTOCOL AGREEMENT 
 
I have read the protocol specified below. In my formal capacity as Investigator, my duties 
include ensuring the safety of the study subjects enrolled under my supervision and 
providing the UCSF Department of Anesthesiology with complete and timely information, 
as outlined in the protocol.  It is understood that all information pertaining to the study 
will be held strictly confidential and that this confidentiality requirement applies to all 
study staff at this site. Furthermore, on behalf of the study staff and myself, I agree to 
maintain the procedures required to carry out the study in accordance with accepted GCP 
principles and to abide by the terms of this protocol. 
 
Protocol Number:  21-35095 
 
Protocol Title: Evaluating the feasibility of virtual reality for procedural sedation in 
pediatric renal biopsy patients 
 
Protocol Date:  October 7, 2021 
 
 
 
 
Investigator Signature  
 
Date 
 
Print Name and Title 
Site # 
 
 
Site Name 
 
Address 
 
 
 
 
 
 
 
Phone Number 
 

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TABLE OF CONTENTS 
1 
BACKGROUND AND STUDY RATIONALE ............................................................................. 9 
1.1 
RISK / BENEFIT ASSESSMENT ......................................................................................................... 9 
2 
STUDY OBJECTIVES ............................................................................................................... 10 
2.1 
PRIMARY OBJECTIVE ................................................................................................................... 10 
2.2 
SECONDARY OBJECTIVES ............................................................................................................ 10 
3 
STUDY DESIGN ......................................................................................................................... 10 
3.1 
STUDY OVERVIEW ....................................................................................................................... 10 
4 
CRITERIA FOR EVALUATION ............................................................................................... 10 
4.1 
PRIMARY ENDPOINT .................................................................................................................... 10 
4.2 
SECONDARY ENDPOINTS ............................................................................................................. 11 
5 
SUBJECT SELECTION ............................................................................................................. 11 
5.1 
STUDY POPULATION .................................................................................................................... 11 
5.2 
INCLUSION CRITERIA ................................................................................................................... 11 
5.3 
EXCLUSION CRITERIA ................................................................................................................. 11 
6 
CONCURRENT MEDICATIONS .............................................................................................. 11 
6.1 
ALLOWED MEDICATIONS AND TREATMENTS .............................................................................. 11 
6.2 
PROHIBITED MEDICATIONS AND TREATMENTS ........................................................................... 12 
7 
STUDY TREATMENTS ............................................................................................................. 12 
7.1 
METHOD OF ASSIGNING SUBJECTS TO TREATMENT GROUPS ....................................................... 12 
7.2 
SUPPLY AND STORAGE OF VR HEADSET ..................................................................................... 12 
8 
STUDY PROCEDURES AND GUIDELINES ............................................................................ 12 
8.1 
CLINICAL ASSESSMENTS ............................................................................................................. 12 
8.1.1 
Medical History ..................................................................................................................... 12 
8.1.2 
Demographics ........................................................................................................................ 12 
8.1.3 
Vital Signs .............................................................................................................................. 12 
9 
ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION ..................................... 13 
9.1 
ADVERSE EVENTS ....................................................................................................................... 13 
9.2 
MEDICAL MONITORING ............................................................................................................... 13 
10 
DISCONTINUATION AND REPLACEMENT OF SUBJECTS ................................................ 13 
10.1 
EARLY DISCONTINUATION OF VR EXPERIENCE .......................................................................... 13 
10.2 
WITHDRAWAL OF SUBJECTS FROM THE STUDY ........................................................................... 13 
11 
PROTOCOL VIOLATIONS ....................................................................................................... 14 
12 
STATISTICAL METHODS AND CONSIDERATIONS ........................................................... 14 
12.1 
DEMOGRAPHIC AND BASELINE CHARACTERISTICS ...................................................................... 14 
12.2 
ANALYSIS OF PRIMARY ENDPOINT .............................................................................................. 14 
12.3 
ANALYSIS OF SECONDARY ENDPOINTS ....................................................................................... 14 
12.4 
SAMPLE SIZE AND RANDOMIZATION ........................................................................................... 14 
13 
DATA COLLECTION, RETENTION AND MONITORING .................................................... 15 
13.1 
DATA MANAGEMENT PROCEDURES ............................................................................................ 15 

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13.2 
AVAILABILITY AND RETENTION OF INVESTIGATIONAL RECORDS ............................................... 15 
13.3 
MONITORING ............................................................................................................................... 15 
13.4 
SUBJECT CONFIDENTIALITY ........................................................................................................ 15 
14 
ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS ................................ 15 
14.1 
PROTOCOL AMENDMENTS ........................................................................................................... 16 
14.2 
INSTITUTIONAL REVIEW BOARDS AND INDEPENDENT ETHICS COMMITTEES ............................... 16 
14.3 
INFORMED CONSENT FORM ......................................................................................................... 16 
14.4 
PUBLICATIONS ............................................................................................................................. 17 
14.5 
INVESTIGATOR RESPONSIBILITIES ............................................................................................... 17 
 
 

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PROTOCOL SYNOPSIS 
TITLE 
Evaluating the feasibility of virtual reality for procedural sedation in 
pediatric renal biopsy patients 
SPONSOR 
UCSF Department of Anesthesiology 
FUNDING 
ORGANIZATION 
UCSF Department of Anesthesiology 
NUMBER OF SITES 
1 
RATIONALE 
Pediatric renal biopsies at UCSF are currently performed with 
pharmacologic sedation or under general anesthesia (GA) to maximize 
patient comfort and anxiolysis. Although this has become standard 
practice, there are both short-term and long-term consequences for 
using sedation and GA, including aspiration, laryngospasm, and 
neurocognitive effects. Prior studies have evaluated alternatives to 
pharmacologic sedation for minor medical procedures in pediatric 
patients, including acupressure, aromatherapy, hypnosis, and music 
therapy. Virtual reality (VR) is a low-cost and commercially available 
distraction tool that engages the user in an immersive and interactive 
experience. Prior studies have evaluated the potential role of VR in 
reducing pain and anxiety associated with IV placement, port access, 
induction of GA, and IUD placement. Renal biopsies are a relatively 
non-invasive and common pediatric procedure performed among 
patients admitted for transplant surveillance or evaluation. To our 
knowledge, there have been no studies to assess the use of VR as an 
alternative to pharmacologic sedation for pediatric renal biopsies.  
 
The aim of this study is to assess the feasibility of using VR to 
successfully complete renal biopsies in renal transplant patients as an 
adjunct to reduce or eliminate the need for pharmacologic sedation. In 
addition, secondary aims include assessing patient pain and anxiety, 
safety of the procedure, and patient/parent/provider satisfaction. 
STUDY DESIGN 
The proposed study is a feasibility study / non-randomized 
prospective study. 
PRIMARY 
OBJECTIVE 
The primary aim of the study is to assess if use of VR eliminates or 
reduces the need for intravenous pharmacologic sedation for children 
undergoing renal biopsy. 
SECONDARY 
OBJECTIVES 
Secondary aims include assessing patient pain and anxiety, safety of 
the procedure, and patient/parent/provider satisfaction. 
NUMBER OF 
SUBJECTS 
32 
SUBJECT 
SELECTION 
CRITERIA 
Inclusion Criteria: 
For pediatric renal biopsy patients: 
- Patients age 5-17 receiving a renal biopsy at UCSF Benioff 
Children's Hospital 

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For providers: 
- The pediatric hospitalist and sedation nurse participating in the renal 
biopsy 
 
Exclusion Criteria: 
For pediatric renal biopsy patients: 
- Patients who cannot lie supine for their renal biopsy 
- Patients with injuries to the head/face that would prohibit wearing a 
headset 
- Patients with loss of consciousness, altered mental status, life-
threatening injuries/illness or multi-trauma 
- Patients with open skin, lice, scabies, or other infectious skin 
conditions on the head/face 
- Patients with a history of or current symptoms of vertigo 
- Patients who are blind 
- Patients with significant developmental or cognitive delays who may 
not be able to engage with or tolerate the virtual reality environment, 
as determined by their parent/caregiver 
- Patients on whom the VR headset does not fit appropriately 
 
For providers: 
- Providers who cannot use the pain and anxiety scales provide 
- Providers with a personal relationship to the patient/caregivers 
TEST PRODUCT 
The study will use the Samsung Gear VR headset. The headset 
displays a preselected, interactive game that features an animated 
animal character moving through a landscape. 
CONTROL PRODUCT 
None 
DURATION OF 
SUBJECT 
PARTICIPATION 
AND DURATION OF 
STUDY 
Each renal biopsy takes approximately 30 minutes to complete, which 
should not be significantly different with the VR headset. Subject 
participation is limited to the periprocedural times; there are no other 
requirements to participate in the study.  
 
Subjects will be recruited throughout the year from the pool of 
patients being admitted for their renal biopsies at UCSF Benioff 
Children’s Hospital. Approximately 75 to 100 pediatric renal biopsies 
are performed annually at UCSF, so the study is anticipated to be 
completed in less than one year to meet the recruitment goal of 32 
subjects. 
CONCOMITANT 
MEDICATIONS 
Allowed: Standard of care local and intravenous sedation medications 
(e.g., fentanyl, midazolam)  
 
Prohibited: General anesthesia 
PRIMARY ENDPOINT 
Total sedation requirement in pediatric patients undergoing renal 
biopsy using VR 

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SECONDARY 
ENDPOINTS 
- Patient pre- and post-procedural pain [assessed by Observation Scale 
of Behavioral Distress (OSBD) 11-point behavioral scale] 
- Patient pre- and post-procedural anxiety [assessed by Children's Fear 
Scale (CFS 0-4 scale), Childhood Anxiety Meter (CAM 0-10 scale)] 
SAFETY 
EVALUATIONS 
Will monitor continuously for incidence of adverse events 
(hypoxemia, hemodynamic instability, severe pain) 
STATISTICS 
Primary Analysis Plan 
Continuous and categorical variables will be analyzed using the 
student’s t test and Chi-squared test. 
Rationale for Number 
of Subjects 
The investigators are primarily interested in precise estimates of 
feasibility and acceptability, as well as outcome variability that will 
aid in the planning of a larger, sufficiently powered efficacy trial. A 
sample size of 32 per group will allow the team to be relatively 
precise in our conclusions regarding feasibility outcomes. For 
example, if there is a 15% attrition rate out of the 32 enrolled in the 
intervention group, the 95% CI for that rate would be (2.6%, 27.4%). 
 

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1 
BACKGROUND AND STUDY RATIONALE 
Pediatric renal biopsies at UCSF are currently performed with pharmacologic sedation or 
under general anesthesia (GA) to maximize patient comfort and anxiolysis. Although this 
has become standard practice, there are both short-term and long-term consequences for 
using sedation and GA, including aspiration, laryngospasm, and neurocognitive effects. 
Prior studies have evaluated alternatives to pharmacologic sedation for minor medical 
procedures in pediatric patients, including acupressure, aromatherapy, hypnosis, and 
music therapy.  
 
To the investigators’ knowledge, there have been no studies to assess the use of VR as an 
alternative to pharmacologic sedation for pediatric renal biopsies. Virtual reality (VR) is a 
low-cost and commercially available distraction tool that engages the user in an 
immersive and interactive experience. Prior studies have evaluated the potential role of 
VR in reducing pain and anxiety associated with IV placement, port access, induction of 
GA, and IUD placement. Renal biopsies are a relatively non-invasive and common 
pediatric procedure performed among patients admitted for transplant surveillance or 
evaluation. 
1.1 
Risk / Benefit Assessment 
With regards to the VR experience itself, there are no common side effects of using the 
VR headset and experiencing the VR environment. Rare side effects include headache, 
nausea, and dizziness. Risk and discomfort will be minimized as the intervention utilizes a 
non-invasive, non-pharmacological VR headset application. The study is conducted by 
trained personnel and designed to use a method that may reduce periprocedural pain and 
anxiety by providing audiovisual distraction. 
There is some risk that those subjects who elect to use the VR headset without any 
additional pharmacologic sedation may experience more pain than those who use the VR 
headset in addition to pharmacologic sedation. The risk of additional pain will be 
minimized through a number of interventions. First, standard of care local anesthesia will 
be used at the biopsy site regardless of the amount of intravenous sedation. In addition, all 
standard of care intravenous sedation medications will be available throughout the biopsy, 
and the same experienced sedation nurse will perform the sedation for all the biopsies and 
continuously monitor pain through a validated pain scale. Subjects or their parents may 
request these sedation medications at any time, and they may also be administered by the 
providers at their discretion.  
 
While the risks of pain and discomfort are somewhat unique to the VR intervention, they 
also still exist in all children undergoing renal biopsies even with standard of care 
intravenous sedation. That is, there always exists the possibility that sedation medications 
may be under-dosed or rescue doses will need to be provided to achieve adequate 
analgesia and anxiolysis. With the administration of local anesthesia as well as availability 
and rapid onset of action of available intravenous sedation medications, there is no 
significant added risk to those patients using the VR headset compared to the standard of 
care.  

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2 
STUDY OBJECTIVES 
2.1 
Primary Objective 
The primary objective of this study is to assess the feasibility of using VR to successfully 
complete renal biopsies in renal transplant patients as an adjunct to reduce or eliminate the 
need for pharmacologic sedation.  
2.2 
Secondary Objectives 
The secondary objectives of this study include assessing patient pain and anxiety, safety 
of the procedure, and patient/parent/provider satisfaction. 
3 
STUDY DESIGN 
3.1 
Study Overview 
In this nonrandomized feasibility study, children aged 5-17 scheduled for routine renal 
biopsy at UCSF Benioff Children’s Hospital will be offered the option to use a virtual 
reality (VR) headset as part of their renal biopsy experience. They will be oriented to the 
VR environment and headset when they arrive at the hospital prior to going to the 
procedure room for the biopsy. The VR experience will be the same for all patients 
participating in the study. The study will utilize a Samsung Gear VR headset that 
displays a preselected, interactive game that features an animated animal character 
moving through a landscape. The standard of care of sedation medications will still be 
available to patients who are unable to complete the procedure with only the VR headset 
without pharmacologic sedation. Pain and anxiety will be monitored continuously using 
validated scales by a pediatric hospitalist and sedation nurse who routinely perform these 
procedures. These providers, as well as patients and parents, may ask for additional 
medications for adequate analgesia and anxiolysis. All renal biopsies conducted during 
this study will be performed as medically indicated by the patients' routine care, and no 
additional biopsies will be performed for the purpose of assessing the utility of VR. 
 
Pre- and post-procedural anxiety and pain, as well as satisfaction with the VR 
experience, will be assessed from the patient, parent(s)/caregiver(s), and providers. In 
addition, all study subjects will be continuously monitored as per standard of care 
throughout the procedure (including heart rate, respiratory rate and oxygen saturation), as 
well as total exposure to pharmacologic sedation medications and recovery time. The 
Children's Fear Scale (CFS 0-4 scale), Childhood Anxiety Meter (CAM 0-10 scale), and 
Observation Scale of Behavioral Distress (OSBD 11-point behavioral scale) are validated 
tools to assess pediatric anxiety and pain. As far as parent and provider experience, the 
additional survey questions are included in the attached study documents. 
4 
CRITERIA FOR EVALUATION 
4.1 
Primary Endpoint 
The primary endpoint of the study is the reduction in the required dose of pharmacologic 
sedation for each subject. The cumulative sedation required for each patient (in mg/kg) 
will be compared to the standard of care, and patients receiving repeat biopsies will have 

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their cumulative sedation requirement for the biopsy with VR compared to their most 
recent prior biopsy without VR. 
4.2 
Secondary Endpoints 
The secondary endpoints of the study are pain and anxiety, as well as subject, caregiver, 
and provider satisfaction. Pain and anxiety will be assessed using the following validated 
tools: the Children's Fear Scale (CFS 0-4 scale), Childhood Anxiety Meter (CAM 0-10 
scale), and Observation Scale of Behavioral Distress (OSBD 11-point behavioral scale). 
Subjects, caregivers, and providers will also receive a post-procedural survey to assess the 
impact and feasibility of the VR intervention. 
5 
SUBJECT SELECTION 
5.1 
Study Population 
Subjects undergoing a renal biopsy at UCSF Benioff Children’s Hospital who meet the 
inclusion and exclusion criteria will be eligible for participation in this study.   
5.2 
Inclusion Criteria 
1. Children ages 5-17 undergoing a renal biopsy at UCSF Benioff Children’s Hospital 
5.3 
Exclusion Criteria 
For pediatric renal biopsy patients: 
1. Patients who cannot lie supine for their renal biopsy 
2. Patients with injuries to the head/face that would prohibit wearing a headset 
3. Patients with loss of consciousness, altered mental status, life-threatening 
injuries/illness or multi-trauma 
4. Patients with open skin, lice, scabies, or other infectious skin conditions on the 
head/face 
5. Patients with a history of or current symptoms of vertigo 
6. Patients who are blind 
7. Patients with significant developmental or cognitive delays who may not be able to 
engage with or tolerate the virtual reality environment, as determined by their 
parent/caregiver 
8. Patients on whom the VR headset does not fit appropriately 
 
For providers: 
1. Providers who cannot use the pain and anxiety scales provide 
2. Providers with a personal relationship to the patient and/or caregivers 
6 
CONCURRENT MEDICATIONS 
6.1 
Allowed Medications and Treatments 
Local anesthesia will be administered at the biopsy site for all patients regardless of the 
additional sedation they may require in addition to the VR headset. Standard of care 
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and may be requested by the patient or caregiver or administered at the discretion of the 
sedation/biopsy providers. 
6.2 
Prohibited Medications and Treatments 
General anesthesia induction medications are prohibited, and any concurrent biopsies or 
treatments other than a renal biopsy are also prohibited. 
7 
STUDY TREATMENTS 
7.1 
Method of Assigning Subjects to Treatment Groups 
Due to the objectives of this feasibility study and the nature of the VR intervention, the 
study subjects will be non-randomized and the subjects and providers will be non-blinded. 
A larger randomized (though also non-blinded) trial is a potential future goal of the 
research team. 
7.2 
Supply and Storage of VR Headset 
The UCSF Department of Anesthesiology has access to two Samsung Gear VR Headsets 
that are stored at UCSF Benioff Children’s Hospital. The devices will remain stored there 
and will be accessed as needed for the study. The headsets will be re-configured to ensure 
they are still functional and sanitized prior to re-use with each biopsy. There should not be 
issues with supply of the headsets since no more than 4 renal biopsies are conducted per 
week at UCSF Benioff Children’s Hospital and none occur simultaneously. 
8 
STUDY PROCEDURES AND GUIDELINES 
The study procedures are diagrammed in Appendix 1. 
Prior to conducting any study-related activities, written informed consent and the Health 
Insurance Portability and Accountability Act (HIPAA) authorization will be signed and 
dated by the subject or their caregiver.  If appropriate, assent will also be obtained prior to 
conducting any study-related activities. 
8.1 
Clinical Assessments 
8.1.1 
Medical History 
All pertinent medical history, including prior sedation requirements, comorbid 
depression/anxiety, and  
8.1.2 Demographics  
Demographic information (date of birth, gender, race) will be confirmed from the patient 
medical record. 
8.1.3 
Vital Signs 
Vital signs (heart rate, respiratory rate, blood pressure, pulse oximetry) will be monitored 
continuously throughout the renal biopsy as per the standard of care. 

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9 
ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION 
9.1 
Adverse Events 
Information regarding occurrence of adverse events will be captured throughout the study. 
Duration, outcome, and severity of these events will be reported as appropriate using the 
iRIS Adverse Event Reporting Form per the federal guidelines issues by the Office of 
Human Research Protections (OHRP). 
9.2 
Medical Monitoring 
Omar Salman, MD should be contacted directly at these numbers to report medical 
concerns or questions regarding safety. 
Phone: (415) 514-1815 
Pager: (415) 443-3434 
10 DISCONTINUATION AND REPLACEMENT OF SUBJECTS 
10.1 Early Discontinuation of VR Experience 
A subject may be discontinued from the VR intervention at any time if the subject, their 
caregiver, the investigator, or any of the providers feel that it is not in the subject’s best 
interest to continue. The following is a list of possible reasons for study treatment 
discontinuation: 
• Subject withdrawal of consent 
• Subject is not compliant with study procedures 
• Adverse event that in the opinion of the investigator would be in the best interest 
of the subject to discontinue study treatment 
If a subject is withdrawn from treatment due to an adverse event, the subject will be 
followed and treated by the investigator until the abnormal parameter or symptom has 
resolved or stabilized.   
All subjects are free to withdraw from participation at any time, for any reason, specified 
or unspecified, and without prejudice. 
Reasonable attempts will be made by the investigator to provide a reason for subject 
withdrawals. The reason for the subject’s withdrawal from the study will be specified in 
the subject’s source documents Refer to Section 10 for early termination procedures. 
10.2 Withdrawal of Subjects from the Study 
A subject may be withdrawn from the study at any time if the subject, the investigator, or 
the Sponsor feels that it is not in the subject’s best interest to continue.   
All subjects are free to withdraw from participation at any time, for any reason, specified 
or unspecified, and without prejudice. 

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Reasonable attempts will be made by the investigator to provide a reason for subject 
withdrawals.  The reason for the subject’s withdrawal from the study will be specified in 
the subject’s source documents.  
11 PROTOCOL VIOLATIONS 
A protocol violation occurs when the subject or investigator fails to adhere to significant 
protocol requirements affecting the inclusion, exclusion, subject safety and primary 
endpoint criteria.  Protocol violations for this study include, but are not limited to, the 
following: 
• Failure to meet inclusion/exclusion criteria 
• Use of a prohibited concomitant medication 
When a protocol violation occurs, it will be discussed with the investigator and a Protocol 
Violation Form detailing the violation will be generated. This form will be signed by a 
Sponsor representative and the Investigator. A copy of the form will be filed in the site’s 
regulatory binder and in the Sponsor’s files. 
12 STATISTICAL METHODS AND CONSIDERATIONS 
Prior to the analysis of the final study data, a detailed Statistical Analysis Plan (SAP) will 
be written describing all analyses that will be performed.  The SAP will contain any 
modifications to the analysis plan described below.   
12.1 Demographic and Baseline Characteristics 
The following demographic variables will be obtained: race, gender, age, medical 
comorbidities. 
12.2 Analysis of Primary Endpoint 
Cumulative sedation administered with the use of VR (in mg/kg) will be compared to the 
standard dose administered using the student’s t test. For subjects receiving a repeat 
biopsy, the student’s t test will be used to compare their sedation needs with the VR 
experience compared to their most recent prior biopsy without VR. 
12.3 Analysis of Secondary Endpoints 
Pre- and post-procedure pain and anxiety as measured on the scales mentioned above will 
be analyzed using the student’s t test and Chi-squared test. 
12.4 Sample Size and Randomization 
The investigators are primarily interested in precise estimates of feasibility and 
acceptability, as well as outcome variability that will aid in the planning of a larger, 
sufficiently powered efficacy trial. A sample size of 32 per group will allow the team to be 
relatively precise in our conclusions regarding feasibility outcomes. For example, if there 
is a 15% attrition rate out of the 32 enrolled in the intervention group, the 95% CI for that 
rate would be (2.6%, 27.4%). Given the nature of this feasibility study, subjects will not 
be randomized. 

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13 DATA COLLECTION, RETENTION AND MONITORING 
The investigators will prepare and maintain adequate and accurate source documents 
designed to record all observations and other pertinent data for each subject who 
participates in the study. All other information shall remain in the electronic health record 
(EHR), which is secured by the University of California, San Francisco. Subjects will not 
be identified by name in any study documents to be collected by the UCSF Department of 
Anesthesiology (or designee), but will be identified by subject number. 
13.1 Data Management Procedures 
The data will be entered into a validated database. Database lock will occur once quality 
assurance procedures have been completed. 
All procedures for the handling and analysis of data will be conducted using good 
computing practices meeting FDA guidelines for the handling and analysis of data for 
clinical trials. 
13.2 Availability and Retention of Investigational Records 
The Investigators will make study data accessible to the monitor, other authorized 
representatives of the Sponsor (or designee), IRB/IEC, and Regulatory Agency (e.g., 
FDA) inspectors upon request.  A file for each subject will be maintained that includes the 
signed Informed Consent, HIPAA Authorization and Assent Form and copies of all source 
documentation related to that subject. The Investigators will ensure the reliability and 
availability of source documents. All study documents will be kept secured in a locked file 
cabinet within the UCSF Department of Anesthesiology for 3 years per federal guidelines. 
13.3 Monitoring 
Monitoring visits will be conducted by representatives of the Sponsor according to the 
U.S. CFR Title 21 Parts 50, 56, and 312 and ICH Guidelines for GCP (E6).  By signing 
this protocol, the Investigators grant permission to the Sponsor (or designee), and 
appropriate regulatory authorities to conduct on-site monitoring and/or auditing of all 
appropriate study documentation. 
13.4 Subject Confidentiality 
In order to maintain subject confidentiality, only a subject number and subject initials will 
identify all study subjects on all documentation submitted.  Additional subject 
confidentiality issues (if applicable) are covered in the Clinical Study Agreement. 
14 ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS 
The study will be conducted according to the Declaration of Helsinki, Protection of 
Human Volunteers (21 CFR 50), Institutional Review Boards (21 CFR 56), and 
Obligations of Clinical Investigators (21 CFR 312). 
To maintain confidentiality, all laboratory specimens, evaluation forms, reports and other 
records will be identified by a coded number and initials only.  All study records will be 
kept in a locked file cabinet and code sheets linking a patient’s name to a patient 
identification number will be stored separately in another locked file cabinet.  Clinical 

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information will not be released without written permission of the subject, except as 
necessary for monitoring by the FDA.  The Investigators will also comply with all 
applicable privacy regulations (e.g., Health Insurance Portability and Accountability Act 
of 1996, EU Data Protection Directive 95/46/EC). 
14.1 Protocol Amendments 
Any amendment to the protocol will be written by the UCSF Department of 
Anesthesiology.  Protocol amendments cannot be implemented without prior written 
IRB/IEC approval except as necessary to eliminate immediate safety hazards to patients.  
A protocol amendment intended to eliminate an apparent immediate hazard to patients 
may be implemented immediately, provided the IRBs are notified within five working 
days. 
14.2 Institutional Review Boards and Independent Ethics Committees 
The protocol and consent form will be reviewed and approved by the IRB/IEC of each 
participating center prior to study initiation. Serious adverse experiences regardless of 
causality will be reported to the IRB/IEC in accordance with the standard operating 
procedures and policies of the IRB/IEC, and the Investigators will keep the IRB/IEC 
informed as to the progress of the study. The Investigators will obtain assurance of 
IRB/IEC compliance with regulations. 
Any documents that the IRB/IEC may need to fulfill its responsibilities (such as protocol, 
protocol amendments, Investigators’ Brochure, consent forms, information concerning 
patient recruitment, payment or compensation procedures, or other pertinent information) 
will be submitted to the IRB/IEC.  The IRB/IECs written unconditional approval of the 
study protocol and the informed consent form will be in the possession of the 
Investigators before the study is initiated.  The IRB/IECs unconditional approval 
statement will be transmitted by the Investigators to the UCSF Department of 
Anesthesiology prior to the shipment of study supplies to the site.  This approval will refer 
to the study by exact protocol title and number and will identify the documents reviewed 
and the date of review. 
Protocol and/or informed consent modifications or changes may not be initiated without 
prior written IRB/IEC approval except when necessary to eliminate immediate hazards to 
the patients or when the change(s) involves only logistical or administrative aspects of the 
study.  Such modifications will be submitted to the IRB/IEC and written verification that 
the modification was submitted and subsequently approved will be obtained.   
The IRB/IEC will be informed of revisions to other documents originally submitted for 
review; serious and/or unexpected adverse experiences occurring during the study in 
accordance with the standard operating procedures and policies of the IRB; new 
information that may affect adversely the safety of the patients of the conduct of the study; 
an annual update and/or request for re-approval; and when the study has been completed. 
14.3 Informed Consent Form  
Informed consent will be obtained in accordance with the Declaration of Helsinki, ICH 
GCP, US Code of Federal Regulations for Protection of Human Subjects (21 CFR 

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50.25[a,b], CFR 50.27, and CFR Part 56, Subpart A), the Health Insurance Portability and 
Accountability Act (HIPAA, if applicable), and local regulations. 
The Investigators have prepared an informed consent form, assent and HIPAA 
authorization and have submitted these documents to the study sponsor and IRB/IEC. The 
written consent document embodies the elements of informed consent as described in the 
International Conference on Harmonization and also complies with local regulations. The 
Investigator will send an IRB/IEC-approved copy of the Informed Consent Form to the 
Sponsor for the study file. 
A properly executed, written, informed consent will be obtained from each subject prior to 
entering the subject into the trial. Information will be given in both oral and written form 
and subjects (or their legal representatives) will be given ample opportunity to inquire 
about details of the study. If appropriate and required by the local IRB/IEC, assent from 
the subject will also be obtained. If a subject is unable to sign the informed consent form 
(ICF) and the HIPAA authorization, a legal representative may sign for the subject. A 
copy of the signed consent form (and assent) will be given to the subject or legal 
representative of the subject and the original will be maintained with the subject’s records. 
14.4 Publications  
The preparation and submittal for publication of manuscripts containing the study results 
shall be in accordance with a process determined by mutual written agreement among the 
study Sponsor and participating institutions. The publication or presentation of any study 
results shall comply with all applicable privacy laws, including, but not limited to, the 
Health Insurance Portability and Accountability Act of 1996.  
14.5 Investigator Responsibilities 
By signing the Agreement of Investigator form, the Investigator agrees to: 
1. Conduct the study in accordance with the protocol and only make changes after 
notifying the UCSF Department of Anesthesiology (or designee), except when to 
protect the safety, rights or welfare of subjects. 
2. Personally conduct or supervise the study (or investigation). 
3. Ensure that the requirements relating to obtaining informed consent and IRB review 
and approval meet federal guidelines, as stated in § 21 CFR, parts 50 and 56. 
4. Report to the Sponsor or designee any AEs that occur in the course of the study, in 
accordance with §21 CFR 312.64. 
5. Ensure that all associates, colleagues and employees assisting in the conduct of the 
study are informed about their obligations in meeting the above commitments. 
6. Maintain adequate and accurate records in accordance with §21 CFR 312.62 and to 
make those records available for inspection with the Sponsor (or designee). 
7. Ensure that an IRB that complies with the requirements of §21 CFR part 56 will be 
responsible for initial and continuing review and approval of the clinical study. 

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8. Promptly report to the IRB and the Sponsor (or designee) all changes in the research 
activity and all unanticipated problems involving risks to subjects or others (to 
include amendments and IND safety reports). 
9. Seek IRB approval before any changes are made in the research study, except when 
necessary to eliminate hazards to the patients/subjects. 
10. Comply with all other requirements regarding the obligations of clinical investigators 
and all other pertinent requirements listed in § 21 CFR part 312. 
 

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Protocol Template © CFFT TDN   Effective: 12 SEP 2007 
APPENDIX 1.   VR STUDY METHODOLOGY 
Percutaneous renal biopsy performed 
VR headset removed at completion of biopsy 
prior to patient transport out of procedure room 
Vital signs and pain/anxiety continuously 
monitored by providers during procedure  
Subject and caregiver oriented to VR headset, 
headset fitted prior to transport to procedure room 
Informed consent (and/or assent) obtained from 
caregiver and subject  
Additional intravenous sedation medications given 
per subject/caregiver request or at provider  
(pediatric hospitalist, sedation nurse) discretion 
Local anesthesia at standard dose given prior 
to needle insertion at biopsy site