Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT04595695
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2020-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Clear Masks in Improving Patient Relationships
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
The Effect of Clear Masks in Improving Patient Relationships
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: