Clinical trial NCT05610969
Conditions: Peripheral Nerve Block Anxiety Preoperative Anxiety
Keywords: Midazolam Adjuvants, Anesthesia Anti-Anxiety Agents Hypnotics and Sedatives Tranquilizing Agents Anesthetics GABA Modulators GABA Agents Central Nervous System Depressants Physiological Effects of Drugs Neurotransmitter Agents
Sponsor: University of Pennsylvania
Start date: 2021-09-01; Completion date: 2023-05-08
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is evaluating music vs midazolam as a means of anxiolysis for preoperative single-shot nerve block placement.

Detailed description:
Preoperative anxiety is common and can adversely affect a patient's perioperative course by elevating stress markers, promoting fluctuations in hemodynamics and negatively impacting on postoperative recovery. Preoperative anxiety is routinely treated with pharmacologic agents such as midazolam, a benzodiazepine, which has known, undesirable side effects including respiratory depression, hemodynamic perturbations, and paradoxical effects such as hostility, aggression, and psychomotor agitation. The use of sedative medications requires continuous vital sign monitoring of patients by either anesthesia or nursing personnel and there is a question of whether midazolam helps reduce pre-procedural anxiety compared with placebo. Music is a non-pharmacologic intervention that has been shown to significantly decrease preoperative anxiety. This intervention can be used as an adjunct or even replace pharmacologic agents to help with preoperative anxiety. Music is a modality that is virtually harm-free and relatively cheap in cost. Patients who are unable to tolerate pharmacologic agents to treat preoperative anxiety can greatly benefit from non-pharmacologic options such as music.

Regional anesthesia procedures such as an ultrasound guided, peripheral nerve block is a common bedside procedure done preoperatively. Patients may have some anxiety prior to the administration of this nerve block procedure and may receive sedation for it. However, it is imperative not to over sedate them as constant feedback from the patient is necessary during the procedure. Commonly, midazolam is used to reduce this anxiety, but non-pharmacologic therapies can also reduce anxiety. In our recent published study, we evaluated the use of research-selected, relaxing music, to reduce anxiety before the nerve block is administered. In this study, we used noise-canceling headphones and played research-selected music as our anxiolytic music modality and compared this with midazolam. The findings showed no difference between both groups in the change in anxiety scores from after to before the nerve block, however patients had better satisfaction in the midazolam group and increased difficulty in communication in the music group. We attributed this to not allowing patients to choose their own selection of music and the use of noise-canceling headphones.

Therefore, in this follow-up study, we aim to evaluate the use of patient-selected music via non-noise canceling headphones as a preoperative anxiolytic prior to the administration of a bedside, peripheral nerve block procedure. This study will be conducted at an ambulatory surgical center in a university setting.

Arms: arm 1: self-selected music arm 2: IV midazolam (1mg to 2mg max)
Interventions: intervention 1: Music intervention 2: Midazolam
Intervention descriptions: intervention 1: patients in this group will receive self-selected music after the golden moment has been completed between the patient, provider, and nursing staff intervention 2: patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed

Protocol documents:
Prot_SAP_000.pdf: 
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TO SERENADE OR TO SEDATE? THAT IS STILL THE QUESTION – A FOLLOWUP 
TRIAL ON ANXIOLYTIC OPTIONS BEFORE PERIPHERAL NERVE BLOCKS 
 
 
Principal Investigator  
Veena Graff MD 
Department of Anesthesiology & Critical Care 
51 North 39th Street, 223 Wright-Saunders 
Philadelphia, PA 19104 
Tel: (215) 662-8244 | Fax: (215) 243-3234 | Cell: (570) 730-1350 
Sub Investigator 
Nabil M Elkassabany MD, MSCE 
Lu Cai MD 
Ignacio Badiola MD 
Department of Anesthesiology & Critical Care 
Study Product 
Patient choice of music 
 
IRB Number 
 
 
 
Initial version 
1.0 
Date 
31 January 2020 


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Table of Contents 
BACKGROUND AND STUDY RATIONALE ................................................................................................ 6 
1 
INTRODUCTION .................................................................................................................................. 6 
1.1 
BACKGROUND AND RELEVANT LITERATURE ..................................................................................... 6 
2 
STUDY OBJECTIVES ......................................................................................................................... 7 
2.1 
PRIMARY OBJECTIVE ...................................................................................................................... 7 
2.2 
SECONDARY OBJECTIVES (IF APPLICABLE) ...................................................................................... 7 
3 
INVESTIGATIONAL PLAN .................................................................................................................. 7 
3.1 
GENERAL DESIGN .......................................................................................................................... 7 
3.2 
ALLOCATION TO INTERVENTIONAL GROUP [IF APPLICABLE] ............................................................... 7 
3.3 
STUDY MEASURES ......................................................................................................................... 7 
3.4 
STUDY ENDPOINTS......................................................................................................................... 9 
3.4.1 
Primary Study Endpoints ......................................................................................................... 9 
3.4.2 
Secondary Study Endpoints .................................................................................................... 9 
4 
STUDY POPULATION AND DURATION OF PARTICIPATION ........................................................ 9 
4.1 
DURATION OF STUDY PARTICIPATION .............................................................................................. 9 
4.2 
TOTAL NUMBER OF SUBJECTS AND SITES........................................................................................ 9 
4.3 
INCLUSION CRITERIA ...................................................................................................................... 9 
4.4 
EXCLUSION CRITERIA ................................................................................................................... 10 
4.5 
SUBJECT RECRUITMENT ............................................................................................................... 10 
4.6 
VULNERABLE POPULATIONS: ........................................................................................................ 10 
5 
STUDY PROCEDURES ..................................................................................................................... 10 
5.1 
SCREENING ................................................................................................................................. 10 
5.2 
STUDY INTERVENTION OR OBSERVATIONAL PHASE (GIVE THIS SECTION A NAME THAT IS RELEVANT TO 
THE DESIGN OF YOUR STUDY)..................................................................... ERROR! BOOKMARK NOT DEFINED. 
5.2.1 
Visit 1 (sometimes referred to as the baseline visit).............................................................. 10 
5.2.2 
Visit 2 ....................................................................................... Error! Bookmark not defined. 
5.2.3 
Visit 3 ....................................................................................... Error! Bookmark not defined. 
5.2.4 
Visit X (If applicable for your study) ......................................... Error! Bookmark not defined. 
5.2.5 
End of Study Visit .................................................................... Error! Bookmark not defined. 
5.3 
UNSCHEDULED VISITS .................................................................. ERROR! BOOKMARK NOT DEFINED. 
5.4 
SUBJECT WITHDRAWAL ................................................................................................................ 11 
5.4.1 
Data Collection and Follow-up for Withdrawn Subjects ........................................................ 11 
5.5 
EARLY TERMINATION VISITS ......................................................... ERROR! BOOKMARK NOT DEFINED. 
5.6 
EFFICACY EVALUATIONS (ONLY IF APPLICABLE) .............................. ERROR! BOOKMARK NOT DEFINED. 
5.7 
PHARMACOKINETIC EVALUATION (ONLY IF APPLICABLE) .................. ERROR! BOOKMARK NOT DEFINED. 
5.8 
GENETIC TESTING (ONLY IF APPLICABLE) ....................................... ERROR! BOOKMARK NOT DEFINED. 
5.9 
SAFETY EVALUATION (ONLY IF APPLICABLE) ................................................................................... 11 
6 
STATISTICAL PLAN ......................................................................................................................... 11 
6.1 
SAMPLE SIZE AND POWER DETERMINATION ................................................................................... 11 
6.2 
STATISTICAL METHODS ................................................................................................................ 11 
6.3 
CONTROL OF BIAS AND CONFOUNDING (IF APPLICABLE, TYPICALLY OBSERVATIONAL STUDY OR IF 
RANDOMIZATION IS NOT TAKING PLACE) ...................................................... ERROR! BOOKMARK NOT DEFINED. 
6.3.1 
Baseline Data ........................................................................................................................ 11 
6.3.2 
Analysis of Primary Outcome of Interest ............................................................................... 11 
6.3.3 
Pharmacokinetic Analysis (only if applicable) ......................... Error! Bookmark not defined. 
6.3.4 
Interim Analysis ....................................................................... Error! Bookmark not defined. 
7 
SAFETY AND ADVERSE EVENTS ................................................................................................... 12 
7.1 
DEFINITIONS ................................................................................................................................ 12 
7.1.1 
Adverse Event ....................................................................................................................... 12 


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7.1.2 
Serious Adverse Event .......................................................................................................... 12 
7.2 
RECORDING OF ADVERSE EVENTS ................................................................................................ 12 
7.3 
RELATIONSHIP OF SAE TO STUDY ................................................................................................ 12 
7.4 
REPORTING OF SERIOUS ADVERSE EVENTS AND UNANTICIPATED PROBLEMS ................................. 12 
7.4.1 
Follow-up Report ................................................................................................................... 13 
7.4.2 
Investigator reporting: notifying the study sponsor (if applicable)Error! 
Bookmark 
not 
defined. 
7.4.3 
Data and Safety Monitoring Plan........................................................................................... 13 
8 
STUDY ADMINISTRATION, DATA HANDLING AND RECORD KEEPING .................................... 13 
8.1 
CONFIDENTIALITY ......................................................................................................................... 13 
8.2 
DATA COLLECTION AND MANAGEMENT .......................................................................................... 13 
8.3 
RECORDS RETENTION .................................................................................................................. 13 
9 
STUDY MONITORING, AUDITING, AND INSPECTING .................................................................. 13 
9.1 
STUDY MONITORING PLAN ............................................................................................................ 13 
9.2 
AUDITING AND INSPECTING ........................................................................................................... 14 
10 
ETHICAL CONSIDERATIONS .......................................................................................................... 14 
10.1 
RISKS .......................................................................................................................................... 14 
10.2 
BENEFITS .................................................................................................................................... 14 
10.3 
RISK BENEFIT ASSESSMENT ......................................................................................................... 14 
10.4 
INFORMED CONSENT PROCESS / HIPAA AUTHORIZATION .............................................................. 14 
10.4.1 
Alterations to Typical Consent Process (only include if applicable)Error! Bookmark not 
defined. 
11 
STUDY FINANCES ............................................................................................................................ 14 
11.1 
FUNDING SOURCE ........................................................................................................................ 14 
11.2 
CONFLICT OF INTEREST ................................................................................................................ 14 
11.3 
SUBJECT STIPENDS OR PAYMENTS ............................................................................................... 14 
12 
PUBLICATION PLAN ............................................................. ERROR! BOOKMARK NOT DEFINED. 
13 
REFERENCES ................................................................................................................................... 15 
14 
ATTACHMENTS ..................................................................... ERROR! BOOKMARK NOT DEFINED. 
15 
APPENDICES ......................................................................... ERROR! BOOKMARK NOT DEFINED. 
15.1 
EXAMPLE: TABLE 1: SCHEDULE OF STUDY PROCEDURES ............ ERROR! BOOKMARK NOT DEFINED. 
15.2 
STUDIES INVOLVING RESEARCH MRIS .......................................... ERROR! BOOKMARK NOT DEFINED. 
15.3 
STUDIES INVOLVING RESEARCH RADIATION ................................... ERROR! BOOKMARK NOT DEFINED. 
15.4 
STUDIES INVOLVING RESEARCH CT SCANS ................................... ERROR! BOOKMARK NOT DEFINED. 
15.5 
STUDIES INVOLVING NUCLEAR MEDICINE REGULATED RESEARCH PROCEDURESERROR! 
BOOKMARK 
NOT DEFINED. 
15.6     RESEARCH STUDIES INVOLVING PATHOLOGY AND LAB MEDICINE…………………………………….. 20 
15.7      REFERENCE FOR SAFETY REPORTING SECTION- COMMON DEFINITIONS FOR DEVELOPING ADVERSE 
EVENT TRACKING AND SERIOUS ADVERSE EVENT REPORTING PROTOCOL  
15.8 
SOURCE DOCUMENTS .................................................................. ERROR! BOOKMARK NOT DEFINED. 
15.9 
CASE REPORT FORMS (CRFS) ..................................................... ERROR! BOOKMARK NOT DEFINED. 
 


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Study Summary 
 
Title 
TO SERENADE OR TO SEDATE? THAT IS STILL THE 
QUESTION – A FOLLOWUP TRIAL ON ANXIOLYTIC 
OPTIONS BEFORE PERIPHERAL NERVE BLOCKS 
Short Title 
TO SERENADE OR TO SEDATE? 
IRB Number 
 
Methodology 
A prospective, randomized controlled study 
Study Duration 
One year 
Study Center(s) 
Single-center, ambulatory surgical center, at a university hospital 
Objectives 
Primary: 
• 
To compare the change in preoperative anxiety scores between study 
groups from after to before placement of a peripheral nerve block. 
Secondary: 
• 
To evaluate differences in hemodynamics, block times, patient 
satisfaction scores, provider satisfaction scores, evaluation difficulty in 
communication between provider and patient, and adverse effects 
between both study groups  
Number of Subjects 
160 


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Main Inclusion and 
Exclusion Criteria 
Inclusion:  patients who are >18 years of age who are able to give informed 
consent who are scheduled to receive any type of peripheral nerve block either 
for their primary anesthetic or for postoperative pain control in the preoperative 
bay at the ambulatory surgical center. 
Exclusion:  patients who have an associated significant psychiatric disorder 
such as generalized anxiety disorder, panic disorder, depression, psychosis, 
bipolar disorder; individuals who were incompetent to give informed consent; 
pregnant and/or breast feeding patients; any underlying coagulopathy, 
infection or other factors which would be a contraindication to receiving a 
peripheral nerve block; hypersensitivity to midazolam; and history of renal 
impairment. Patients who were extremely anxious (scores 50 and greater on 
the State Trait Anxiety Inventory-6 (STAI-6) tool) as these patients typically 
require pharmacologic therapy to help reduce their anxiety and may confound 
the results of the study. 
Intervention  
There will be two study groups who will be randomized. 1. Music group: Music 
group – patients will select music of their choice to be played via non-noise 
canceling headphones. 2. Midazolam group:  patients in this group will receive 
IV midazolam (1mg to 2mg max) after the golden moment has been 
completed. 
 
In our daily practice, it is the provider’s preference to give patients medication 
for sedation while conducting the preoperative nerve block. Patients do not 
routinely get sedation medication during the preoperative nerve block 
placement. 
Statistical 
Methodology 
1:1 Randomized controlled study 
Data and Safety 
Monitoring Plan  
The PI, Dr. Graff and her MD collaborator Dr. Nabil Elkassabany will be 
responsible for data safety and monitoring. All data will be kept in a locked 
cabinet in the MD collaborator’s office. The PI and collaborators will perform 
safety reviews after 25 subjects are enrolled. Any protocol-related problem or 
deviation will be reported to Dr. Graff and/or Dr. Nabil Elkassabany as soon as 
possible.  
 


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Background and Study Rationale 
1 
Introduction 
This document is a research protocol and the described study will be conducted in compliance with the 
provisions set forth in the protocol as well as, Good Clinical Practice standards, associated federal 
regulations, and all applicable University research requirements.  
 
Preoperative anxiety is common and can adversely affect a patient’s perioperative course by elevating 
stress markers, promoting fluctuations in hemodynamics and negatively impacting on postoperative 
recovery.1 Preoperative anxiety is routinely treated with pharmacologic agents such as midazolam, a 
benzodiazepine, which has known, undesirable side effects including respiratory depression, 
hemodynamic perturbations, and paradoxical effects such as hostility, aggression, and psychomotor 
agitation.2,3 The use of sedative medications requires continuous vital sign monitoring of patients by either 
anesthesia or nursing personnel and there is a question of whether midazolam helps reduce pre-
procedural anxiety compared with placebo. Music is a non-pharmacologic intervention that has been 
shown to significantly decrease preoperative anxiety.1,4–6 This intervention can be used as an adjunct or 
even replace pharmacologic agents to help with preoperative anxiety. Music is a modality that is virtually 
harm-free and relatively cheap in cost. Patients who are unable to tolerate pharmacologic agents to treat 
preoperative anxiety can greatly benefit from non-pharmacologic options such as music. 
 
Regional anesthesia procedures such as an ultrasound guided, peripheral nerve block is a common 
bedside procedure done preoperatively. Patients may have some anxiety prior to the administration of 
this nerve block procedure and may receive sedation for it. However, it is imperative not to over sedate 
them as constant feedback from the patient is necessary during the procedure. Commonly, midazolam is 
used to reduce this anxiety, but non-pharmacologic therapies can also reduce anxiety.1,5 In our recent 
published study, we evaluated the use of research-selected, relaxing music, to reduce anxiety before the 
nerve block is administered.7 In this study, we used noise-canceling headphones and played research-
selected music as our anxiolytic music modality and compared this with midazolam.7 The findings showed 
no difference between both groups in the change in anxiety scores from after to before the nerve block, 
however patients had better satisfaction in the midazolam group and increased difficulty in 
communication in the music group. We attributed this to not allowing patients to choose their own 
selection of music and the use of noise-canceling headphones.    
 
Therefore, in this follow-up study, we aim to evaluate the use of patient-selected music via non-noise 
canceling headphones as a preoperative anxiolytic prior to the administration of a bedside, peripheral 
nerve block procedure. This study will be conducted at an ambulatory surgical center in a university 
setting. 
1.1 
Background and Relevant Literature  
 
Patients often feel a tremendous amount of anxiety prior to their planned surgical procedure and 
anesthetic. As a result, this can affect their perioperative period by elevating their stress markers, causing 
various fluctuations in their hemodynamics, and poorly impacting their postoperative recovery.1 A 
significant number of patients have anxiety about the anticipation in their overall outcome and 
postoperative pain control.2,3 To treat preoperative anxiety, pharmacologic agents such as short-acting 
benzodiazepines and opioids are used as needed depending on an individual basis; however, there are 
known significant side effects from these medications such as respiratory depression, vital sign 
abnormalities, and possible apnea which limit the use of these medications and in some instances, 
prevent the use for preoperative anxiety. In addition to this, utilization of these medications for conscious 
sedation also require continuous monitoring of a patient by either anesthesia personnel or nursing staff. 
 
Music is a non-pharmacologic intervention that has been shown to significantly decrease preoperative 
anxiety.1,4,6 This intervention can be used as an adjunct or even replace pharmacologic agents to help 
with preoperative anxiety1. Music is a modality that is virtually harm-free and relatively cheap in cost. 
Patients who are unable to tolerate pharmacologic agents to treat preoperative anxiety can greatly benefit 
from non-pharmacologic options such as music. 


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The Speilberger’s validated tool, the State Trait Anxiety Inventory (STAI), is one of the best measured 
tools to evaluate preoperative anxiety. The STAI has been referred to as the “gold standard” in properly 
evaluating preoperative anxiety.8 There are two components to this tool; a state portion which evaluates 
the current state of anxiety a patient has in a clinical setting, and a trait portion which evaluates how the 
patient generally feels unrelated to the clinical setting. Each of these sections have 20 items to answer 
and approximately takes 10-15 minutes to complete. In preoperative anxiety testing, the STAI-S is 
commonly used in research to properly evaluate the level of preoperative anxiety in the current clinical 
setting. Marteau and her colleagues have developed a shortened STAI version, the STAI-6, that has also 
been validated.8 The shortened STAI-6 tool has six questions and may be more beneficial to use in a high 
turnover, ambulatory surgical center setting as it only takes a few minutes to complete. 
 
We will be using the STAI-6 short form questionnaire to score the preoperative anxiety levels in our 
patient population.  
 
2 
Study Objectives 
2.1 
Primary Objective 
To determine preoperative anxiety score differences between patients who receive music vs IV 
midazolam during their preoperative nerve block placement. 
2.2 
Secondary Objectives (if applicable) 
To evaluate differences in hemodynamics, block times, patient satisfaction scores, provider satisfaction 
scores, evaluation difficulty in communication between provider and patient, and adverse effects between 
both study groups  
3 
Investigational Plan  
3.1 
General Design 
This will be a prospective, randomized controlled study. Participants will be randomized to receiving 
research-selected music versus IV midazolam (1mg to 2mg max) during their preoperative peripheral 
nerve block placement.  
3.2 
Allocation to Interventional Group [if applicable] 
Subjects will be randomized to either music or IV midazolam. Subjects will be randomized in a one to one 
fashion and the randomization will take place using a computer-generated algorithm.  
3.3 
Study Measures 
There will be two study groups who will be randomized. 1. Music group – patients will select their choice 
of music via non-noise canceling headphones. 2. Midazolam group:  patients in this group will receive IV 
midazolam (1mg to 2mg max) after the golden moment has been completed.  
 
A pre-anxiety score will be obtained using the STAI-6 validated tool after the patient has signed the 
informed consent. After the golden moment is completed, the intervention will start. Once the nerve block 
is completed, a post anxiety score will be obtained using STAI-6 validated tool.  
 
For our primary outcome measure, we will use the short form of the state scale of the Spielberger State-
Trait Anxiety Inventory (STAI-6) to measure pre procedure and post procedure anxiety levels (see below). 
The shortened STAI-6 tool has six questions and may be more beneficial to use in a high turnover, 
ambulatory surgical center setting as it only takes a few minutes to complete. In the original 20-item STAI-
State tool, the scores range from 20 to 80. A score greater than 50 on the original 20-item scale is 
associated with a high level of anxiety. The population normal score is approximately 35 (Speilberger 
1983). In the STAI-6 tool, there are six questions with a Likert scale from 1 to 4. This gives a score range 


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from 6 to 24. To create scores compatible with the original STAI-S scores, the STAI-6 scores will be 
divided by 6 and multiplied by 20 to give a range from 20 to 80. 
 
 
 
For our secondary outcome measure, we will obtain the following information: 
 
1.  Patient satisfaction scores using a 10-point visual analogue scale (VAS) as follows: 
 
“Using any number from 0 to 10, where 0 is the WORST experience possible and 10 is the BEST 
experience possible, what number would you use to rate your overall preoperative experience while 
getting a peripheral nerve block placed?” 
 
 
 
 
 
 
 
 
 
2. Provider satisfaction scores using a 10-point visual analogue scale (VAS) as follows: 
 
 “Using any number from 0 to 10, where 0 is the WORST experience possible and 10 is the BEST 
experience possible, what number would you use to rate your overall preoperative experience while 
placing a peripheral nerve block for your patient?” 
 
 
 
 
 
 
 
 
 
3. Evaluation of communication difficulties between provider and patient by asking one question on 
a 5-point Likert scale: 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
WORST 
BEST 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
WORST 
BEST 


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From provider to patient: 
“I found it difficult to communicate with the patient while doing the preoperative nerve block.” 
A. Strongly Disagree 
B. Disagree 
C. Neutral 
D. Agree 
E. Strongly Agree 
 
From patient to provider: 
“I found it difficult to communicate with the physician while the preoperative nerve block was being 
done on me.” 
A. Strongly Disagree 
B. Disagree 
C. Neutral 
D. Agree 
E. Strongly Agree 
 
 
3.4 
Study Endpoints  
3.4.1 Primary Study Endpoint 
The primary end point will be to determine change in the anxiety scores using the STAI-6 tool between 
the music group and the IV midazolam group. 
3.4.2 Secondary Study Endpoints 
The secondary end points will be to determine any differences in patient satisfaction scores, provider 
satisfaction scores, evaluation of difficulties in communication between provider and patient, 
hemodynamics, block times, and adverse effects including paresthesia’s, patchy block, failed block, and 
serious adverse effects including bleeding, infection, paralysis, local anesthetic systemic toxicity between 
both groups. 
 
4 
Study Population and Duration of Participation  
The study population will include patients who are >18 years of age, who will give informed consent in 
receiving a peripheral nerve block in the preoperative bay for their primary anesthetic and/or for their 
postoperative pain control. 
 
We will exclude the following: patients who have an associated significant psychiatric disorder such as 
anxiety, panic disorder, depression, psychosis, or bipolar disorder; patients who are unable to give 
informed consent; patients who are pregnant; patients who have an underlying coagulopathy and 
infection. 
4.1 
Duration of Study Participation  
The study duration will be from the time informed consent occurs to after the perioperative block has been 
completed. Once the post-anxiety STAI-6 score has been obtained, the study is complete. 
4.2 
Total Number of Subjects and Sites  
Total number of subjects will be 160; 80 in the music group and 80 in the IV midazolam group. Study will 
take place at Penn Medicine University City, PMUC. 
4.3 
Inclusion Criteria 
Patients who are >18 years of age, who will give informed consent in receiving a peripheral nerve block in 
the preoperative bay for their primary anesthetic and/or for their postoperative pain control. 


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4.4 
Exclusion Criteria 
We will exclude the following: patients who have an associated significant psychiatric disorder such as 
generalized anxiety disorder, panic disorder, depression, psychosis, bipolar disorder; individuals who 
were incompetent to give informed consent; pregnant and/or breast feeding patients; any underlying 
coagulopathy, infection or other factors which would be a contraindication to receiving a peripheral nerve 
block; hypersensitivity to midazolam; and history of renal impairment. Patients who were extremely 
anxious (scores 50 and greater on the State Trait Anxiety Inventory-6 (STAI-6) tool) 
4.5 
Subject Recruitment  
All patients will be screened initially at the preoperative surgical clinic visit. Any patient that cannot be 
reached will be approached in the preoperative bay during the preoperative period of their planned 
surgery. Subjects will be given the details about the study and given adequate time to read the consent 
form and talk the study over with family that accompanies them. 
4.6 
Vulnerable Populations:  
Children, pregnant women, fetuses, neonates, or prisoners are not included in this research study. 
5 
Study Procedures  
5.1 
Screening  
The general flow of the study will be conducted as follows: 
1. Research coordinator will call or approach patients who are scheduled for a surgical 
procedure that is planning for a peripheral nerve block either for the primary anesthetic or for 
postoperative pain control to be placed in the preoperative bay in the ambulatory surgical 
center. 
2. Research coordinator will discuss the purpose of our study and explain the study in detail for 
the patient. If a patient agrees to participate, then we will have the patient sign the informed 
consent for the study.  
5.1.1 Visit 
3. Once the patient signs the informed consent for the peripheral nerve block by anesthesia 
team. The patient randomized will be revealed to either music or IV midazolam. The pre-
procedure anxiety score will then be obtained using the STAI-6 validated tool. 
4. The golden moment will be conducted between the patient, provider, and nursing staff. Once 
this golden moment is completed, the anxiolytic intervention will start (music or IV 
midazolam)* 
5. The preoperative nerve block will be conducted by the regional anesthesia block team. 
6. Once the nerve block is completed, the post-procedure anxiety score will be obtained, and 
we will also obtain the patient satisfaction score, the provider satisfaction score, and the 
evaluation of any difficulties in communication between the provider and patient. After these 
questions have been obtained, the study is complete. 
 
A minimum of 1mg and a maximum of 2mg of IV midazolam will be given in the IV midazolam group. 
 
Peripheral nerve blocks are conducted under ultrasound guidance according to standard practice at 
PMUC. 
 
Vital signs such as heart rate, blood pressure, respiratory rate, and oxygen saturation are routinely 
obtained as a part of standard of care if sedation medication is used and when peripheral nerve blocks 
are placed. 
 


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Starting block time and ending block time are routinely obtained as a part of the patient record.  
 
 
During this entire process, patient demographics, hemodynamics (heart rate, blood pressure, oxygen 
saturation, and respiratory rate), block times (start and end time), and any adverse effects including 
paresthesia’s, patchy block, failed block, and serious adverse effects including bleeding, infection, 
paralysis, local anesthetic systemic toxicity will be recorded as the routine part of practice. 
5.2 
Subject Withdrawal  
Subjects may withdraw from the study at any time without impact to their care. They may also be 
discontinued from the study at the discretion of the Investigator for lack of adherence to intervention or 
study procedures or AEs. It will be documented whether or not each subject completes the study. 
5.2.1 Data Collection and Follow-up for Withdrawn Subjects 
Data will still be collected for subjects who withdrawal from the study. In cases where subjects wish to 
withdrawn PHI consent they will be able to do so by telling a study team member in person or through 
information provided on the ICF. 
5.3 
Safety Evaluation 
When evaluating safety, the doctors will look at any reported AE’s as well as patients who are unwilling or 
unable to adhere to the randomized allocation. If patients in either group have more than 25% deviation 
rate the inclusion and exclusion as well as block method will be reevaluated to better limit deviations. 
 
6 
Statistical Plan 
6.1 
Sample Size and Power Determination 
Based on a previous study by Bringman et.al.  the mean (SD) of STAI anxiety score is  34(8). 5A clinically 
meaningful decrease, as determined by the Cochrane review group was 0.5 of SD.1,5 Our sample size 
calculation to detect a 4-point change in pain score (p less than 0.05 significance level) was 64 patients 
(α=0.05, power=80%). We will inflate out sample size by 25% to account for any missing data or any 
withdrawal from the study; therefore, our estimated sample size will be 80 patients per group. 
6.2 
Statistical Methods 
Statistical analyses will be performed using STATA 13 statistical software (Dallas, TX). Demographic or 
other categorical data will be analyzed using T test or Fishers exact test as appropriate. Repeated 
measurements (STAI-6 scores) will be analyzed by using the t-test or Mann-Whitney U-test as 
appropriate. Normally distributed data will be presented as means ± SE of the mean (SEM), non-normally 
distributed data are presented as medians ± quartiles (interquartile range) and categorical data will be 
presented as raw data and as frequencies. The alpha level for all analyses was set as P less than 0.05. 
6.2.1 Baseline Data 
Demographic or other categorical data will be analyzed using T test or Fishers exact test as appropriate. 
6.2.2 Analysis of Primary Outcome of Interest 
Repeated measurements (STAI-6 scores) will be analyzed by using the t-test or Mann-Whitney U-test as 
appropriate. 
 


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7 
Safety and Adverse Events 
This section provides the safety management plans for the study. This section should be consistent with 
the Penn IRB guidelines tailored to the requirements specific for each study. It should describe how 
safety reporting will be monitored and take place over the course of the trial.  
7.1 
Definitions 
7.1.1 Adverse Event 
Study definition of an adverse event (AE). Can include the Penn IRB definition of an adverse event unless 
there are some differences in the adverse event definitions for this particular study. Standard definition of 
an adverse event as follows: 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study.  Intercurrent illnesses or injuries should be regarded as adverse events.  
Abnormal results of diagnostic procedures are considered to be adverse events if the abnormality: 
• 
results in study withdrawal 
• 
is associated with a serious adverse event 
• 
is associated with clinical signs or symptoms 
• 
leads to additional treatment or to further diagnostic tests 
• 
is considered by the investigator to be of clinical significance 
7.1.2 Serious Adverse Event 
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE that is:  
• 
fatal 
• 
life-threatening 
• 
requires or prolongs hospital stay 
• 
results in persistent or significant disability or incapacity 
• 
required intervention to prevent permanent impairment or damage 
• 
a congenital anomaly or birth defect 
• 
an important medical event 
7.2 
Recording of Adverse Events 
Information on all adverse events will be recorded immediately in the source document, and also in the 
appropriate adverse event module of the case report form (CRF).  All clearly related signs, symptoms, 
procedures results will be recorded in the source document. 
 
All adverse events occurring during the study period will be recorded.  The clinical course of each event 
will be followed until resolution, stabilization, or until it has been determined that the study intervention or 
participation is not the cause.  Serious adverse events that are still ongoing at the end of the study period 
will be followed up to determine the final outcome.  Any serious adverse event that occurs after the study 
period and is considered to be possibly related to the study intervention or study participation will be 
recorded and reported. 
7.3 
Relationship of AE to Study  
The PI will supervise the assessment of relationship of each adverse even to the study procedures. The 
adverse events, if such occurs, will be classified as definitely related, probably related, possibly related, 
unlikely or unrelated. 
7.4 
Reporting of Adverse Events and Unanticipated Problems 
The Investigator will promptly notify the Penn IRB of all on-site unanticipated, Adverse Events that are 
related to the research activity. Other unanticipated problems related to the research involving risk to 


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subjects or others will also be reported promptly. Written reports will be filed using the HS-ERA and in 
accordance with the Penn IRB timeline of 10 working days. 
7.4.1 Follow-up Report 
If an AE has not resolved at the time of the initial report and new information arises that changes the 
investigator’s assessment of the event, a follow-up report including all relevant new or reassessed 
information (e.g., concomitant medication, medical history) should be submitted to the IRB. The 
investigator is responsible for ensuring that all SAEs are followed until either resolved or stable. 
7.4.2 Data and Safety Monitoring Plan 
The PI, Dr. Graff and her collaborator Dr. Nabil Elkassabany will be responsible for data safety and 
monitoring. All paper data will be kept in a locked cabinet in the MD collaborator’s office. The PI and 
collaborators will perform safety reviews after 25 patients are enrolled. Any protocol-related problem or 
deviation will be reported to Dr. Graff and/or Dr. Nabil Elkassabany as soon as possible. 
 
8 
Study Administration, Data Handling and Record Keeping 
8.1 
Confidentiality 
Information about study subjects will be kept confidential and managed according to the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those regulations require a 
signed subject authorization informing the subject of the following:  
• 
What protected health information (PHI) will be collected from subjects in this study 
• 
Who will have access to that information and why 
• 
Who will use or disclose that information 
• 
The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject  
Study date will be stored on a Penn institutionally secured and managed server specific to the 
Anesthesiology Department in a locked folder only for this protocol.  
8.2 
Data Collection and Management  
Demographic information will be collected from patient charts. Information about sedation onset, block 
start and stop as well as survey information will be captured on paper that will be stored on Penn campus 
in secured building in locked office in locked filing cabinets. Subjects will be given a study number at time 
of enrollment. De-identified data will be inputted into a department and folder password secured excel 
sheet. 
Once study analysis is complete identifiable information linking subject to study number will be destroyed/ 
deleted. 
8.3 
Records Retention 
Records will be retained up to 3 years after the completion of research. Electronic records of directly 
collected data will subsequently be destroyed from electronic server. 
 
9 
Study Monitoring, Auditing, and Inspecting 
9.1 
Study Monitoring Plan 
The study will be monitored by Dr. Graff and Dr. Elkassabany. 


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9.2 
Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the IRB, government 
regulatory bodies, and University compliance and quality assurance groups of all study related 
documents (e.g. source documents, regulatory documents, data collection instruments, study data etc.).  
The investigator will ensure the capability for inspections of applicable study-related facilities. 
10 Ethical Considerations 
Study will be submitted to the Penn IRB for approval before study enrollment begins. Any changes to the 
protocol will we preapproved by the IRB before any changes to study practice is made. 
10.1 
Risks 
The risks of the study are related to the administration of midazolam which include tenderness and pain 
during injection at IV site. This risk is addressed in the local block consent form and thus is not putting 
subjects at a greater risk. 
10.2 
Benefits 
The individual subjects may not receive any benefit from participating in this study. Potential benefit could 
be increased relaxation and lower anxiety from music sedation or midazolam. For the study population 
this study hopes to prove that non medicinal sedation is adequate for subject comfort and a decrease in 
anesthetics can be achieved. 
10.3 
Risk Benefit Assessment 
The potential benefits are greater to the limited risks for patients thus this study should be conducted. 
10.4 
Informed Consent Process / HIPAA Authorization  
All subjects for this study will be provided a consent form describing this study providing sufficient 
information for subjects to make an informed decision about their participation in this study.  This consent 
form will be submitted with the protocol for review and approval by the IRB for the study.  The formal 
consent of a subject, using the IRB-approved consent form, must be obtained before that subject 
undergoes any study procedure.  The subject, must sign the consent form, and the investigator-
designated research professional obtaining the consent. Subjects will be consented by the study Principal 
Investigator, or appropriate designee, in perioperative holding room assigned at check in. Potential 
subjects will review the consent form in detail with the person designated to consent (either PI or CRC) 
and have the ability to review consent with family or friends that accompanied them to PMUC.  
 
11 Study Finances 
11.1 
Funding Source 
This study is not funded. 
11.2 
Conflict of Interest 
No conflicts of interest have been noted by initial study team if conflict arises the IRB will be notified 
according to regulations. All University of Pennsylvania Investigators will follow the University of 
Pennsylvania Policy on Conflicts of Interest Related to Research.  
11.3 
Subject Stipends or Payments 
Subjects will not be paid for study. 
 


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12 References 
1.  Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Anaesthesia, 
Critical and Emergency Care Group, ed. Cochrane Database of Systematic Reviews. June 2013. 
doi:10.1002/14651858.CD006908.pub2 
2.  Maranets I, Kain ZN. Preoperative Anxiety and Intraoperative Anesthetic Requirements: Anesthesia 
& Analgesia. 1999;89(6):1346. doi:10.1097/00000539-199912000-00003 
3.  Kain ZN, Sevarino F, Alexander GM, Pincus S, Mayes LC. Preoperative anxiety and postoperative 
pain in women undergoing hysterectomy. Journal of Psychosomatic Research. 2000;49(6):417-422. 
doi:10.1016/S0022-3999(00)00189-6 
4.  Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: A systematic 
review 
and 
meta-analysis. 
The 
Lancet. 
2015;386(10004):1659-1671. 
doi:10.1016/S0140-
6736(15)60169-6 
5.  Bringman H, Giesecke K, Thörne A, Bringman S. Relaxing music as pre-medication before surgery: 
A randomised controlled trial. Acta Anaesthesiologica Scandinavica. 2009;53(6):759-764. 
doi:10.1111/j.1399-6576.2009.01969.x 
6.  Gooding L, Swezey S, Zwischenberger JB. Using Music Interventions in Perioperative Care: 
Southern Medical Journal. 2012;105(9):486-490. doi:10.1097/SMJ.0b013e318264450c 
7.  Graff V, Cai L, Badiola I, Elkassabany NM. Music versus midazolam during preoperative nerve block 
placements: A prospective randomized controlled study. Reg Anesth Pain Med. 2019;44(8):796-799. 
doi:10.1136/rapm-2018-100251 
8.  Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger 
State-Trait Anxiety Inventory (STAI). British Journal of Clinical Psychology. 1992;31(3):301-306. 
doi:10.1111/j.2044-8260.1992.tb00997.x 
 

ICF_001.pdf: 
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UNIVERSITY OF PENNSYLVANIA 
RESEARCH SUBJECT 
INFORMED CONSENT AND HIPAA AUTHORIZATION FORM 
 
Protocol Title:   
To Serenade or To Sedate? That is still the 
question – a follow-up trial on anxiolytic options 
before peripheral nerve blocks 
Principal 
Investigator: 
Veena Graff MD, MS 
Department of Anesthesiology & Critical Care 
Penn Pain Medicine Center 
51 North 39th Street, 223 Wright-Saunders 
Philadelphia, PA 19104 
Emergency 
Contact: 
***Ask for the Anesthesia Resident On Call  
Be sure to tell the resident you are participating in 
this study.  
215 908-0400 
 
 
  
Research Study Summary for Potential Subjects 
 
You are being invited to participate in a research study.  Your participation is voluntary, 
and you should only participate if you completely understand what the study requires 
and what the risks of participation are.  You should ask the study team any questions 
you have related to participating before agreeing to join the study.  If you have any 
questions about your rights as a human research participant at any time before, during 
or after participation, please contact the Institutional Review Board (IRB) at (215) 898-
2614 for assistance. 
 
You are scheduled to receive peripheral nerve block procedure as your primary type of 
anesthesia for the surgery you have been scheduled for and/or for the purposes of pain 
control after the surgery is complete. When you get this peripheral nerve block, it is 
done before you enter the operating room, in the preoperative area. This procedure 
typically takes approximately 10 minutes. In several cases, you may not need any form 
of anxiety relieving methods while receiving this peripheral nerve block, as it is not all 
that different than getting your IV placed. However, in times of needing anxiety relieving 
techniques, we routinely offer a variety of methods – either medication assisted 
methods by giving small dose, intravenous anxiety relieving sedation medications such 
as midazolam (also known as Versed) or non-medication methods such as listening to 
music to help relax you. Both methods (music of your choice or small dose sedation 
medication) have been shown in numerous studies to reduce anxiety and relax you 


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when this procedure is done for you. This research study that is being conducted is to 
simply evaluate any differences in anxiety scores, heart rate, blood pressure, and 
oxygen status when using sedation medication versus your choice of listening to music 
while undergoing this peripheral nerve block before your surgery. 
 
If you agree to join the study, you will be asked to complete the following research 
procedures:  
• Before undergoing the peripheral nerve block, you will either receive the sedative 
medication midazolam by intravenous injection or you will receive a pair of 
disposable, non-noise canceling headphones and select your choice of music to 
help ease any anxiety during the procedure. 
• You will be asked to complete questionnaires that will assess your anxiety level 
before the procedure and after the procedure and how satisfied you were with 
your experience while receiving the nerve block. 
 
Your participation will last for approximately 30-60 minutes from the time you agree in 
taking part of the study to after the procedure is done. Before and after the surgery, we 
will conduct an anxiety scoring test which includes six questions to answer and takes 
only a few minutes. 
 
 
You are not expected to benefit directly from the study. Risks of using sedative 
medications include slowing your breathing, stopping breathing, variations in your blood 
pressure and/or heart rate, or reactions opposite of relaxing you such as making you 
potentially agitated or paranoid. There are virtually no side effects of listening to music. 
 
Please note that there are other factors to consider before agreeing to participate such 
as additional procedures, use of your personal information, costs, and other possible 
risks not discussed here. If you are interested in participating, a member of the study 
team will review the full information with you. You are free to decline or stop 
participation at any time during or after the initial consenting process. 
 
Why am I being asked to volunteer? 
You are being invited to participate in a research study because you will be having 
surgery to repair a portion of your upper extremity or lower extremity, and you will receive 
a nerve block containing numbing medication for your pain control protocol after surgery. 
Your participation is voluntary which means you can choose whether or not you want to 
participate. If you choose not to participate, there will be no loss of benefits to which you 
are otherwise entitled. Before you can make your decision, you will need to know what 
the study is about, the possible risks and benefits of being in this study, and what you 
will have to do in this study. The research team is going to talk to you about the research 
study, and they will give you this consent form to read. You may also decide to discuss 
it with your family, friends, or family doctor. You may find some of the medical language 
difficult to understand. Please ask the study doctor and/or the research team about this 
form. If you decide to participate, you will be asked to sign this form. 


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What is the purpose of this research study? 
You are scheduled to undergo surgery that involves your upper extremity or lower 
extremity. To help you with your pain control after surgery, you will receive a nerve 
block containing numbing medication that will numb the specific region your surgeon will 
be working on for pain control after your surgery. This method of pain control is known 
as a peripheral nerve block which is categorized under regional anesthesia as it numbs 
a region of your body. This nerve block involves injecting numbing medication around 
the nerve that provides feeling to the extremity your surgeon will be performing surgeon 
on. 
The nerve block begins to work about 20 minutes after the needle injection. The 
extremity remains numb anywhere from 12 to 24 hours after the surgery. 
 
When conducting this nerve block, your anesthesia team will use ultrasound image 
guidance to visualize the nerve to be numbed. They will numb up your skin with 
numbing medication prior to inserting a needle to inject the numbing medication around 
the nerve. Your heart rate, blood pressure, and oxygen status are routinely recorded 
while this procedure is being done. 
 
During this procedure, patients may or may not get sedative medication. Sedation 
medication is not absolutely required as your skin is numb before injecting the 
medication. Sedation medication is used usually if a patient may experience some 
anxiety before the procedure. Listening to music of your choice has also been used in 
place of sedation medication to help reduce anxiety before surgery and while a 
procedure is being done. 
 
The purpose of this study is to determine if there are differences in anxiety scores, heart 
rate, blood pressure, and oxygen status when using sedation medication versus your 
choice of listening to music while undergoing a peripheral nerve block before your 
surgery. 
 
How long will I be in the study? How many other people will be in the 
study? 
Your expected length of participation in this study is approximately 30-60 minutes from 
the time you agree in taking part of the study to after the procedure is done. Before and 
after the surgery, we will conduct an anxiety scoring test which includes six questions to 
answer and takes only a few minutes. 
 
We plan to enroll 160 subjects who are scheduled to undergo surgery that involves their 
upper or lower extremity in which a peripheral nerve block is done. 


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What am I being asked to do? 
If you sign the consent and agree to participate in this study, you will either receive a 
pair of disposable, non-noise canceling headphones and select your choice of music or 
medication to help ease any anxiety during the procedure. 
 
All medications used are approved by the Food and Drug Administration (FDA).  
If you agree to participate: 
You will be randomized to receive either midazolam, which is a sedation medication, or 
music of your choice. This is a process of chance, similar to being assigned by the flip 
of a coin. The doses of midazolam will be administered according to the standard 
dosing regimen for an adult. The “dosage” or minimum time of listening to music is 
approximately 10-20 minutes. 
By chance you will be assigned to receive one of the following: 
• Midazolam 
• Music of your own choice 
 
You will be asked to complete questionnaires that will assess your anxiety level before 
the procedure and after the procedure and how satisfied you were with your experience 
while receiving the nerve block. 
The research assistant will assist you with completing the questionnaires described 
here: 
State Trait Anxiety Inventory – 6 (STAI-6) Anxiety Scale: 
You will be asked to complete this survey a total of two times before and after your 
procedure. These time points will be before the start of your nerve block procedure and 
after the nerve block has been completed which will be a minimum of 20 minutes 
afterwards. This questionnaire will ask you questions about how you are feeling 
currently. This will take about 5 minutes to complete. 
 
Visual Analogue Scale of your experience 
You will be asked to complete this survey a total of one time at the end of the nerve block 
procedure after you do the anxiety inventory. This survey asks one question about how 
your overall experience was and will take less than 1 minute to complete. 
 
What are the possible risks or discomforts?  
A risk which is common to all studies which include randomization of patients to 
different treatment groups is the removal of the physician’s choice of anxiety preventing 
options. Since both anxiety control options are safe for the patients enrolled in this 
study, we do not foresee this to be a major risk to patients enrolling in this study. There 
is a possibility that outcome measures (like anxiety levels and patient satisfaction) might 
differ between the two nerve types. 


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Most patients receive sedation medication like midazolam to control for anxiety before 
surgery and before doing nerve blocks. However, some patients may not need it and 
some patients may have significant side effects to this medication. Music is a non-
medication type of intervention that has been shown to reduce anxiety before surgery 
and during procedures. Any medications used in this study are FDA-approved. 
You will have been screened by both your surgical and anesthesia team for allergies to 
any medications including those commonly used for anesthesia and post-surgery pain 
control. If you have any previous history of allergies to any of the medications used for 
the block or the standard of care post-surgery and discharge medications, you will not 
be able to participate in this study. 
Common risks of sedation with midazolam include a decrease in your respiratory rate 
(slowing down your breathing). There is virtually no risk to listening to music of your 
choice. 
You will receive care and be monitored throughout and following your nerve block per 
hospital standards as would any other non-study subject. (Standard protocol is the rules 
and regulations that must be followed for patient safety and quality of care). 
Risks of breaches of confidentiality are small but nonetheless possible. However, we 
have taken several measures to protect your identity.  All study data will be stored in 
confidential research files of the research investigator. Records will not contain your 
name or any other personal identifiers. 
 
 
What if new information becomes available about the study? 
During the course of this study, we may find more information that could be important to 
you.  This includes information that, once learned, might cause you to change your mind 
about being in the study.  We will notify you as soon as possible if such information 
becomes available. 
 
What are the possible benefits of the study? 
Benefits can include minimizing or avoiding medications to reduce anxiety. 
What other choices do I have if I do not participate? 
If you do not participate in this study, your sedation regimen during your nerve block 
procedure will be determined by your anesthesia provider. You may ask the study team 
for more information about clinical options available if you do not participate in the 
study. 
 
Will I be paid for being in this study?  
You will not be paid for participating in this study. 
 


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Will I have to pay for anything? 
There is no fee for participating in this study. You and/or your health insurance will be 
billed for the costs of medical care during this study given these expenses would have 
happened even if you were not in the study, or if your insurance agrees in advance to 
pay. 
 
What happens if I am injured from being in the study?  
We will offer you the care needed to treat injuries directly resulting from taking part in 
this research. We may bill your insurance company or other third parties, if appropriate, 
for the costs of the care you get for the injury, but you may also be responsible for some 
of them. 
There are no plans for the University of Pennsylvania to pay you or give you other 
compensation for the injury. You do not give up your legal rights by signing this form. 
If you think you have been injured as a result of taking part in this research study, tell 
the person in charge of the research study as soon as possible. The researcher’s name 
and phone number are listed in the consent form. 
 
When is the study over? Can I leave the study before it ends? 
This study is expected to end after all information has been collected. If you enroll in this 
study and later decide to withdraw your consent, whether before or after your 
procedure, you will be asked to notify a member of the study team. Their information 
can be found on page 1 of this consent form. 
If you are unable to complete the procedure with music or midazolam, the 
anesthesiologist will withdraw you from the study and make sure you are able to 
complete your procedure.  
If the primary investigator feels it is necessary for your health or safety, such an action 
would not require your consent, but you will be informed if such a decision is made and 
the reason for this decision. 
 
Who can see or use my information? How will my personal 
information be protected? 
We will do our best to make sure that the personal information in your medical record 
will be kept private. However, we cannot guarantee total privacy. Your personal 
information may be given out if required by law. If information from this study is 
published or presented at scientific meetings, your name and other personal information 
will not be used. 
 
 
Electronic Medical Records and Research Results  
 


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What is an Electronic Medical Record and/or a Clinical Trial Management  
System?  
An Electronic Medical Record (EMR) is an electronic version of the record of your care 
within a health system. An EMR is simply a computerized version of a paper medical 
record.  
 
A clinical trial management system (CTMS) is used to register your information as a 
participant in a study and to allow for your research data to be entered/stored for the 
purposes of data analysis and any other required activity for the purpose of the conduct 
of the research.  
 
If you are receiving care or have received care within the University of Pennsylvania 
Health System (UPHS) (outpatient or inpatient) and are participating in a University of 
Pennsylvania research study,  information related to your participation in the research 
(i.e. laboratory tests, imaging studies and clinical procedures) may be placed in your 
existing EMR maintained by UPHS. Information related to your participation in clinical 
research will also be contained in the CTMS. 
 
If you have never received care within UPHS and are participating in a University of 
Pennsylvania research study that uses UPHS services, an EMR will be created for you 
for the purpose of maintaining any information produced from your participation in this 
research study.  The creation of this EMR is required for your participation in this study. 
In order to create your EMR, the study team will need to obtain basic information about 
you that would be similar to the information you would provide the first time you visit a 
hospital or medical facility (i.e. your name, the name of your primary doctor, the type of 
insurance you have). Information related to your participation in the study (i.e. laboratory 
tests, imaging studies and clinical procedures) may be placed in this EMR.  
 
Once placed in your EMR or in the CTMS, your information may be accessible to 
appropriate UPHS workforce members that are not part of the research team.  
Information within your EMR may also be shared with others who are determined by 
UPHS to be appropriate to have access to your EMR (e.g. Health Insurance Company, 
disability provider, etc.). 
 
What information about me may be collected, used or shared with 
others?   
The following personal health information will be collected, used for research, and may 
be disclosed during your involvement with this research study: 
• Name, gender, ethnic 
background, date of birth 
• Current and past medications 
or therapies 
 
• Medical record number 
• All information in the Medical Record 
 


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Why is my information being used? 
Your personal contact information is important for the research team to contact you 
during the study. Your personal health information and results of tests and procedures 
are being collected as part of this research study. In some situations, your personal 
health information might be used to help guide your medical treatment. 
 
Who may use and share information about me?   
The following individuals may use or share your information for this research study: 
• The investigator for the study and the study team  
• Other authorized personnel at Penn, including offices that support research 
operations 
• Other research personnel with access to the databases for research and/or study 
coordination and as otherwise approved by the IRB 
 
Which of our personnel may use or disclose your personal health 
information? 
The following individuals may use or disclose your personal health information for this 
research study: 
• The Principal Investigator and the Investigator’s study team 
• Authorized members of the workforce of the UPHS and the School of Medicine, 
and University of Pennsylvania support offices, who may need to access your 
information in the performance of their duties (for example: for research 
oversight and monitoring, to provide treatment, to manage accounting or billing 
matters, etc.). 
 
Who, outside of UPHS and the School of Medicine, might receive your 
personal health information? 
As part of the study, the Principal Investigator, the study team and others listed above, 
may disclose your personal health information, including the results of the research 
study tests and procedures. This information may be disclosed to those listed below: 
Regulatory and safety oversight organizations 
• The Office of Human Research Protections 
• The University of Pennsylvania Institutional Review Board 
If your personal health information is disclosed to others outside of UPHS or the School 
of Medicine, it may no longer be covered by federal privacy protection regulations. The 
Principal Investigator or study staff will inform you if there are any additions to the list 
above during your active participation in the trial. Any additions will be subject to 
University of Pennsylvania procedures developed to protect your privacy. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site 
at any time. 


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How long may the School of Medicine use or disclose my personal 
health information?   
Your authorization for use of your personal health information for this specific study 
does not expire. Your information may be held in a research repository (database). 
However, UPHS and the School of Medicine may not re-use or re-disclose information 
collected in this study for a purpose other than this study unless: 
• You have given written authorization to do so  
• The University of Pennsylvania’s Institutional Review Board grants permission 
after ensuring that appropriate privacy safeguards are in place  
• As permitted by law 
 
Can I change my mind about giving permission for use of my 
information? 
Participation in this study is voluntary.  You may withdraw your approval to allow the use 
and disclosure of your personal health information as described here. You must do so in 
writing to the Principal Investigator at the address on the first page. Even if you 
withdraw your permission, your personal health information that was collected before 
we received your written request may still be used and disclosed, as necessary for the 
study. If you withdraw your permission to use your personal health information, you will 
also be withdrawn from the research study. 
 
What if I decide not to give permission to use and give out my health 
information? 
Then you will not be able to be in this research study. 
 
You will be given a copy of this Research Subject HIPAA Authorization describing your 
confidentiality and privacy rights for this study.  
 
By signing this document, you are permitting the School of Medicine to use and disclose 
personal health information collected about you for research purposes as described 
above. 
 
Who can I call with questions, complaints or if I’m concerned about 
my rights as a research subject? 
If you have questions, concerns or complaints regarding your participation in this 
research study or if you have any questions about your rights as a research subject, you 
should speak with the Principal Investigator listed on page one of this form. If a member 
of the research team cannot be reached or you want to talk to someone other than 
those working on the study, you may contact the Office of Regulatory Affairs with any 
question, concerns or complaints at the University of Pennsylvania by calling (215) 898-
2614. 
 
 


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When you sign this form, you are agreeing to take part in this research study. This 
means that you have read the consent form, your questions have been answered, 
and you have decided to volunteer.  Your signature also means that you are 
permitting the University of Pennsylvania to use your personal health information 
collected about you for research purposes within our institution. You are also allowing 
the University of Pennsylvania to disclose that personal health information to outside 
organizations or people involved with the operations of this study. 
 
A copy of this consent form will be given to you.  
 
 
 
 
 
 
________________________       ____________________________________ 
Name of Subject (Please Print)  Signature of Subject  
 
           Date 
 
 
 
________________________ 
_____________________________________ 
Name of Person Obtaining  
Signature                                  
 
Date 
Consent (Please Print)