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Purpose

To evaluate the effect of wearing masks that hide a surgeon's facial features versus one that shows them. New patients with no prior relationship with the surgeon will be asked questions regarding communication and trust with the surgeon.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Surgeon: - Faculty within Department of Surgery at the University of North Carolina at Chapel Hill - Must be English speaking - Plans to see new in person visits in clinic

Exclusion Criteria

Surgeon: - None Inclusion Criteria Patient: - At least 18 years old - Can understand and speak English without the use of an interpreter - Has capacity to make independent medical decisions Exclusion Criteria Surgeon: - Has a prior relationship with the surgeon - Has symptoms of a respiratory infection (cough, shortness of breath, fever)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Patients will be randomized into typical covered mask versus transparent mask worn by the surgeon.
Primary Purpose
Health Services Research
Masking
Single (Participant)
Masking Description
Patients will not know that their surgeon is participating in a research study. Visits will be completed as they typically would with the surgeon wearing a mask.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Transparent Mask 		Surgeons will be provided a transparent mask for use during in-person clinic visits with a new patient. Otherwise, visits will be conducted as per usual and the patient will be surveyed immediately after the visit.
  • Behavioral: Transparent mask
    A transparent mask worn by the surgeons in customary fashion will be used.
    Other names:
    • ClearMask
Active Comparator
Covered Mask 		Surgeons will be instructed to wear a typical, covered mask for the in-person clinic visit with a new patient. The visit will be conducted as it typically would, and the patient will be surveyed immediately after the visit.
  • Behavioral: Typical surgical covered mask
    A standard covered surgical mask worn by the surgeons in in customary fashion will be used.
    Other names:
    • Halyard

Recruiting Locations

More Details

NCT ID
NCT04595695
Status
Completed
Sponsor
University of North Carolina, Chapel Hill

Detailed Description

Surgeons within the University of North Carolina Department of Surgery will be recruited via an email list-serve. This recruitment email will describe the study and have the consent attached. If the surgeons are interested in participating they will respond to the email and sign the consent form. The project personnel will arrange to attend their clinic that has new patients scheduled. A random group generator will be used to randomize the patients. The surgeons will be provided either a transparent mask that demonstrates their full facial features or their typical mask that covers their mouth, for each new patient visit. Following each visit, the surgeon will tell the project personnel that they are complete and the project personnel will enter the room, introduce the project, obtain verbal consent (enroll the patient) and if agreeable, provide a brief verbal survey to the patient. The survey will entail confidential questions regarding basic demographics, surgeon communication and trust, as well as an impression of the masks. Survey answers will be Likert scale and open ended. Patients will also be given a debriefing form at the completion of their participation. Surgeons will be asked their impression of the mask at the completion of their participation. All data will be kept confidential on password protected devices. If patients do not agree to the study they will not be included. If surgeons feel uncomfortable at any point they may withdraw from the study. Any patient demonstrating concerning symptoms of an infection will not be included in the study. The investigators expect to recruit 10 surgeons, with 10 patients each, totally 100 patients (50 in each arm, clear vs. covered mask). Using Mann-Whitney U test, data will be analyzed for differences in responses between the two groups. Demographic data for both the patient and surgeon will also be analyzed. Patient comments will be qualitatively analyzed for themes by trained researchers.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.