The Effect of Clear Masks on Patient Satisfaction With Physician Communication During Awake Brain Surgery
Phase: NA
Conditions: Communication, Patient Satisfaction
Sponsor: Wake Forest University Health Sciences

Protocol version: 3 
Date updated: 6/8/2023 
1 
Study Title: The effect of clear masks on patient satisfaction with 
physician communication during awake brain surgery 
 
NCT05088603 
 
 
IRB-Approved Date:  08JUN2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Title: The effect of clear masks on patient satisfaction with physician communication during 
awake brain surgery 
 

Protocol version: 3 
Date updated: 6/8/2023 
2 
Principal Investigator, Co-investigator(s):  
Dr. Wesley Hsu, Wake Forest Department of Neurosurgery 
Dr. Chesney S. Oravec, Wake Forest Department of Neurosurgery 
Dr. Kyle Townsend, Wake Forest Department of Neurology 
 
Sponsor or funding source: Masks will be provided by Safe’N’Clear, Inc as a grant for the completion 
of this study. 
 
Background, Rationale and Context 
 
When the coronavirus became a pandemic in early 2020, wearing masks became mandatory in all 
public places. This lead to certain challenges such as difficulty communicating among hearing-impaired 
individuals who may rely lip reading, and the use of clear masks has been shown to alleviate this 
challenge.(Atcherson et al) In the operating room, masks have been worn to reduce the risk of surgical 
site infections. Surgical masks are currently being worn in the operating room during placement of deep 
brain stimulators (DBS) in awake patients for the treatment of medically refractory movement disorders, 
including Parkinson’s disease and Essential Tremor. During DBS surgery, a series of questions and 
assessments are carried out by a neurologist in the operating room to confirm location and appropriate 
placement of the stimulator, requiring patients to be awake and participatory. As the neurologist 
traditionally wears a surgical mask that prevents patients from lip reading, a surgical mask without a clear 
window has the potential to hinder the communication between the neurologist and the patient. It is of 
vital importance that the patient understands and accurately answers the neurologist’s questions to 
facilitate optimal placement of the DBS electrode while maximizing operative efficiency.  
Since the availability of clear masks has increased in the wake of the COVID-19 pandemic, surgeons 
have found improved satisfaction among patients whose surgeons use clear masks when discussing or 
explaining surgery in the outpatient setting. (Kratzke et al) One example of a clear mask is The 
Communicator (Safe’N’Clear, Inc., Davidson, NC, USA), which is the only FDA-approved, ASTM Level 
1 surgical mask. It has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth. 
Clear masks have not been evaluated in the intraoperative setting. Our hypothesis is that the 
utilization of clear surgical masks in the operating room will lead to improved satisfaction and enhance 
communication for patients undergoing DBS surgery.  
 
 
Objective 
 
To evaluate patients’ experience during awake brain surgery when the communicating neurologist 
wears a clear face mask compared with a standard surgical mask. 
 
 
Methods and Measures 
 
Design 
Single-center prospective randomized controlled study  
 
Setting 
Wake Forest Baptist Medical Center 
 
 
Subject selection criteria 
 

Protocol version: 3 
Date updated: 6/8/2023 
3 
 
Study participants who meet the below criteria will be approached for potential participation prior to 
surgery.  
 
• 
Inclusion Criteria 
- 
Age >18 years  
- 
Patients electing to undergo deep brain stimulator placement  
- 
Patient in whom general anesthesia is not planned for stimulator target localization 
 
• 
Exclusion Criteria 
- 
Patients who do not give consent 
- 
Patients who do not undergo DBS placement 
- 
Patients who are blind or have a severe visual impairment 
- 
Non-English speaking patients (i.e., patients for whom an interpreter would be needed to 
conduct the intra-operative assessment) 
 
• 
Sample Size 
- 
Based on statistical calculations and projections, the target sample size will be 60 
patients.  
 
Interventions and Interactions 
 
Patients who both elect to undergo DBS surgery and agree to participate in this study will have a 
record created in the study database. All patients scheduled for a DBS phase I surgery will be contacted 
via telephone in the days prior to their scheduled surgery to discuss the possibility of study participation. 
This will be done to give the patient time to consider study participation in order to avoid delays the 
morning of surgery. The morning of surgery the patient will be approached in pre-operative holding room 
to discuss participation in the study and if amenable sign consent for participation. This discussion will 
inform the patient that minor changes are being made in an attempt to improve the patient experience, but 
limited information regarding what steps exactly will be provided so as to reduce potential bias that might 
result from the patient knowing we are studying a new mask type. If the patient agrees to participation, a 
consent form will be signed and as a baseline will undergo the Hearing Handicap Inventory for the 
Elderly (HHIE-S) questionnaire before the operation (Appendix 1). The patient’s record in the electronic 
study database will then be created and randomized to one of two groups. Group A will experience the 
neurologist wearing a clear mask, and group B will experience the neurologist wearing a standard covered 
mask. The patient and all other intra-operative personnel will wear a covered surgical mask. 
Following standard surgical protocol, the DBS surgery will proceed with the patient awake. First, a 
stereotactic frame is securely attached to the patient’s head and the patient is positioned appropriately. 
Local anesthetic is used for the neurosurgeon to obtain access through the scalp and skull. A 
microelectrode is then stereotactically placed using headframe coordinates. The neurosurgeon sets up the 
motor apparatus to allow the neurologist to advance the microelectrode to the appropriate deep brain 
target, operating the motor from a non-sterile station arranged next to the patient. The microelectrode will 
stimulate and record neuronal activity, during which time the neurologist will ask the patient questions to 
assess for changes in symptoms. These questions typically are of the following nature: 
- Do you notice any tingling or pulling of the mouth or face? 
- Do you see any flashes of light in your vision? 
- Do you feel any tingling or heaviness of an arm or leg? 
- Do you notice any metallic or strange taste? 
- Can you draw a spiral on this piece of paper? 
- Can you hold your arm out in front of you and keep it still? 
During a routine DBS surgery, the neurologist is positioned in view of the patient while operating the 
electrode motor and asking the above questions. Microelectrode stimulation and recording will conclude 

Protocol version: 3 
Date updated: 6/8/2023 
4 
when the appropriate target has been reached; that is, when simulation achieves both symptom 
improvement without new neurologic symptoms. At that point, the microelectrode is withdrawn and the 
macroelectrode is placed. The macroelectrode is stimulated in the determined position to again confirm 
symptom improvement without new neurologic symptom or deficit, and when confirmed the 
neurosurgeon will secure the macroelectrode in place. At this point, the neurologist’s testing portion is 
complete, and the neurologist exits the operating room while the neurosurgeon completes the 
implantation.  
For patients who agree to study participation, the neurologist will wear the mask type assigned by the 
randomization group for the duration of involvement in the surgery. At the conclusion of the neurologist’s 
interaction with the patient, the patient will be asked a series of questions (presented in Appendix 2, Data 
collection form) to evaluate the communication experience. This step will be performed by another 
member of the study team (not the participating neurologist) who will read from the questionnaire and 
record the patient’s responses using the Likert scale (defined in Appendix 2). During questioning, the 
neurologist will step out of the operating room to reduce potential bias from the patients answering 
subjective questions in front of the neurologist.  
At the conclusion of the questionnaire, the patient will undergo a short debriefing regarding the aims 
of the study, specifically the revelation that the purpose of the study is to evaluate the use of a clear 
surgical mask on the patient’s experience, as assessed by the questionnaire.   
At the conclusion of the neurologist’s assessment, as is typical, the patient will be placed under 
sedation for the completion of the DBS implantation. In the event a patient is having bilateral DBS 
implantation in one operation, only the first DBS implantation will be included in the study. For these 
patients, the procedure will be carried out as stated above, but following the first DBS implantation the 
neurologist will continue to interact with the patient for the second DBS implantation. The second 
implantation will not be included in the study data collection.  
A retrospective chart review will be conducted for the 30 day post-operative period to evaluate for 
surgery-related infection. Evaluating for rates of infection between mask groups will help to ensure there 
is no harm associated with use of a non-covered mask during the operation. The patients will not need to 
be contacted or otherwise actively participate in the study during this period; information will be obtained 
via medical record review only. For such a chart review, a waiver of consent will be completed in the IRB 
application. Such a waiver is necessary in order to answer the study question regarding mask safety and 
surgery-related infection, as it would be difficult to retrospectively re-consent every patient already 
enrolled in this nearly-complete study. 
 
Outcomes and Statistical Plan 
 
 
Data will be gathered based on the attached Data Collection Form (Appendix 2). Answers to the 
questionnaire will be deidentified.  
Power calculations will be performed considering the primary endpoint of a dichotomous response to 
question #1 of the CG-CAHPS. Thirty subjects per group will be needed to achieve 80% power to detect 
a difference of 26% or more between proportions (hypothesized standard of care mask positive response 
rate of 73% versus clear mask positive response rate of 99%) with alpha of 5% using conservative two-
sided Fisher’s Exact Test. Therefore the enrollment goal will be 60 subjects total. 
Secondary outcomes will include differences in response to the remaining quantitative questions of 
the CG-CAHPS and free text responses to the final question. As the quantitative question responses are 
on a Likert scale, responses 1-3 will be considered negative and 4 will be considered positive thereby 
converting the outcome to binary according to the top box method. Fisher’s Exact Test will be used to 
investigate a difference between the standard of care mask and the clear mask for all dichotomous 
outcomes. P-values < 0.05 will be considered statistically significant. A content analysis will be 
performed on the free responses to investigate distinct themes. 
 
 

Protocol version: 3 
Date updated: 6/8/2023 
5 
Human Subjects Protection 
 
Subject Recruitment Methods 
 
 
 
Selection of potential study participants will be based upon screening all patients who elect to 
undergo DBS placement during the enrollment period. The decision to undergo DBS placement will be 
made on an individual patient basis between patient/family and treating neurologist and neurosurgeon, 
without regard to consideration or participation in this study. These potential study participants will then 
be screened using inclusion and exclusion criteria above and approached for interest. If amenable, the 
purpose and steps of the study will be further explained, but without divulging the clear mask as the topic 
of study to avoid introducing bias with regard to mask type. If the participant gives consent, the consent 
form will be signed prior to any data collection or randomization. At the conclusion of the patient’s study 
participation (i.e., the completion of the questionnaires intra-operatively) the purpose of the study will be 
fully explained to the patient.  
 
Informed Consent 
 
 
Written informed consent will be obtained prior to data collection or randomization. The risk of harm 
or discomfort is expected to be negligible, as the intraoperative questionnaire is short and not expected to 
extend the length of surgery more than 15 minutes. In addition, the clear mask has been approved for use 
in the operating room by the Food and Drug Administration and is not expected to increase the risk of 
infection compared to the standard covered mask. The rights and welfare of study participants will be 
protected by using measures to maintain the confidentiality of study information. Study results will be 
presented or published in lieu of providing individual subjects additional information regarding the study. 
 
Confidentiality and Privacy 
 
 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing the collection of any information that could directly identify subjects, and maintaining all 
study information in a secure manner. To help ensure subject privacy and confidentiality, only a unique 
study identifier will appear on the data collection form. Any collected patient identifying information 
corresponding to the unique study identifier will be maintained on a linkage file, stored separately from 
the data. The linkage file will be kept secure, with access limited to designated study personnel. 
Following data collection, subject identifying information will be destroyed in three years (consistent 
with data validation and study design), producing an anonymous analytical data set.  Data access will be 
limited to study staff. Data and records will be kept locked and secured, and any computer data will be 
password protected. No reference to any individual participant will appear in reports, presentations, or 
publications that may arise from the study. 
 
Data and Safety Monitoring 
 
 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants. The principal investigator will be assisted by other members of the study staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
 
 
Any unanticipated problems, serious and unexpected adverse events, deviations, or protocol changes 
will be promptly reported by the principal investigator or designated member of the research team to the 
IRB and sponsor or appropriate government agency if appropriate. 
 

Protocol version: 3 
Date updated: 6/8/2023 
6 
References 
1. Atcherson SR, Mendel LL, Baltimore WJ, et al. The effect of conventional and transparent 
surgical masks on speech understanding in individuals with and without hearing loss. J Am Acad 
Audiol. 2017;28 (1):58-67. doi:10.3766/jaaa.15151  
2. Kratzke IM, Rosenbaum ME, Cox C, Ollila DW, Kapadia MR. Effect of Clear vs Standard 
Covered Masks on Communication with Patients During Surgical Clinic Encounters. JAMA Surg. 
2021;156(4):372-378. 
 
Appendix 
1. Hearing Screening Questionnaire 
2. Data collection form 

Protocol version: 3 
Date updated: 6/8/2023 
7 
Appendix 1. Hearing Screening 
 
 
 
Patient ID:  
 
 
 
Date:   
 
 
Rater:   
 
 
 
 
Hearing Handicap Inventory in the Elderly – Screening Questionnaire 
 
Instructions: Answer Yes, No, or Sometimes for each question. Do not skip a question if you avoid a situation because of a 
hearing problem. If you use a hearing aid, please answer according to the way you hear with the aid.  
 
1. Does a hearing problem cause you to feel embarrassed when you meet 
new people?  
Yes (4) No (0) Sometimes (2) 
2. Does a hearing problem cause you to feel frustrated when talking to 
members of your family? 
Yes (4) No (0) Sometimes (2) 
3. Do you have difficulty hearing when someone speaks in a whisper?  
Yes (4) No (0) Sometimes (2) 
4. Do you feel handicapped by a hearing problem?  
Yes (4) No (0) Sometimes (2) 
5. Does a hearing problem cause you difficulty when visiting friends, 
relatives, or neighbors?  
Yes (4) No (0) Sometimes (2) 
6. Does a hearing problem cause you to attend religious services less often 
than you would like? 
Yes (4) No (0) Sometimes (2) 
7. Does a hearing problem cause you to have arguments with family 
members?  
Yes (4) No (0) Sometimes (2) 
8. Does a hearing problem cause you difficulty when listening to TV or 
radio?  
Yes (4) No (0) Sometimes (2) 
9. Do you feel that any difficulty with your hearing limits or hampers your 
personal or social life?  
Yes (4) No (0) Sometimes (2) 
10. Does a hearing problem cause you difficulty when in a restaurant with 
relatives or friends? 
Yes (4) No (0) Sometimes (2) 
 
Total Score:________ 
 
Interpretation of Total Score: 0-8 = no handicap; 10-24 = mild to moderate handicap; 26-40 = severe handicap.  
 
Adapted from: Ventry I, Weinstein B. Identification of elderly people with hearing problems. ASHA. 1983; 25:37-42.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Pr ot oc ol versi o n:  3 
Date  u p date d : 6/ 8/ 2 0 2 3  
8 
A p pe n di x 2 . D at a c ollecti o n f or m 
 
 
P atie nt I D:   
  
  
 
   Ne ur ol o gist:    
  
  
 
      
Gr o u p Assi g n me nt :    A – Clear  
 B – C o vere d  
 
M as k t y pe  use d : Clear / C o vere d 
 
C G -C A H P S Q uesti o ns  
1 = N ot at all  
4 = C o m pletely  
* Di d t his pr o vi der e x plai n t hi n gs i n a wa y t hat was eas y t o u n dersta n d?  
1  
2  
3  
4  
* Di d t his pr o vi der liste n caref ull y t o y o u?  
1  
2  
3  
4  
* Di d t his pr o vi der see m t o k n o w t he i m p orta nt i nf or mati o n a b o ut y o ur me dical hist or y ? 1  
2  
3  
4  
* Di d t his pr o vi der s h o w res pect f or w hat y o u ha d t o sa y?  
1  
2  
3  
4  
* Di d t his pr o vi der s pe n d e n o u g h ti me wit h y o u?  
1  
2  
3  
4  
A d diti o n al Q uesti o ns  
 
 
 
 
* Di d t his pr o vi der de m o nstrate e m pat h y ?  
1  
2  
3  
4  
* H o w c o mf orta ble d o y o u feel tr usti n g Dr. ( Ne ur ol o gist)’s decisi o ns?  
1  
2  
3  
4  
* Di d y o u u n dersta n d w hat y o u were bei n g as ke d t o d o?  
1  
2  
3  
4  
* H o w satisfie d are y o u wit h t he pr oce d ure t h us far o verall?  
1  
2  
3  
4  
 
1 = Str o n gly dislike d  
4 = Str o n gly like d  
†  W hat was y o ur i m pressi o n of t he Ne ur ol o gist’s mas k?  
1  
2  
3  
4  
 
§ W hat c o m me nts d o y o u ha ve a b o ut t he Ne ur ol o gist’s  mas k (s)?   
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
* 4 -p oi nt Likert sc ale ( 1 = n ot at all, 4 =c o m pletely ; † 4 -Likert sc ale ( 1 =str o n gly dislike d, 4 =str o n gly like d ; § Free 
res p o nse; A b brevi ati o ns: C H -C A H P S, Cli nici a n a n d Gr o u p C o ns u mer Assess me nt of He alt hc are Pr ovi ders a n d 
Syste ms