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The Effect of Clear Masks in Improving Patient Relationships

The Effect of Clear Masks in Improving Patient Relationships

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04595695
Enrollment
200
Registered
2020-10-20
Start date
2020-09-03
Completion date
2020-12-14
Last updated
2021-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication, Covid19, Surgery, Trust

Keywords

Masks

Brief summary

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.

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.

Interventions

BEHAVIORALTransparent mask

A transparent mask worn by the surgeons in customary fashion will be used.

BEHAVIORALTypical surgical covered mask

A standard covered surgical mask worn by the surgeons in in customary fashion will be used.

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

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.

Intervention model description

Patients will be randomized into typical covered mask versus transparent mask worn by the surgeon.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Patient Mask Preference QuantitativeDuring 1-minute survey assessed immediately after clinic visit completionUsing a Likert scale question evaluating patient preference for the type of mask (What was your impression of the surgeon's mask? Did not like the mask, somewhat did not like the mask, somewhat liked the mask, completely liked the mask, scored as 1 to 4 with higher score indicating greater preference).
Patient Mask Preference QualitativeDuring 1-minute survey assessed immediately after clinic visit completionPatients will be asked for their comments about the surgeon's mask and these will be immediately transcribed.
Patient Survey Scores Evaluating Surgeon Communication SkillsDuring 1-minute survey assessed immediately after clinic visit completionUsing Likert scale questions evaluating patient perception of surgeon communication, taken from the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) healthcare survey, each scored 1-4 with higher number indicating greater communication skills, from not at all, somewhat, mostly to completely. This will include 6 questions evaluating communication skills with identical answer choices. Each participants total score will range from 6 to 24 with higher indicating better communication skills.
Patient Survey Scores Describing Trust in the SurgeonDuring 1-minute survey assessed immediately after clinic visit completionUsing Likert scale questions evaluating patient trust of the surgeon, asked, How comfortable do you feel trusting this surgeon's decisions. Answer choices are score 1 - 4 with 4 indicating great trust, from Completing uncomfortable, somewhat uncomfortable, somewhat comfortable, completely comfortable

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026