NCT05088603

Effect of Clear Masks on Patient Satisfaction With Communication

The Effect of Clear Masks on Patient Satisfaction With Physician Communication During Awake Brain Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate participants' experience and satisfaction during the awake deep brain stimulation (DBS) procedure. Normally, the neurologist will ask the participant questions and also ask the participant to perform tasks during surgery. During this time, the neurologist will be talking to the participant and the participant will be responding by answering questions or participating with the tasks. For some study participants, there will be one small change made to the typical way the neurologist conducts this evaluation. The study staff will then ask the study participants about their experience with the neurologist's evaluation. The subject will not be told what part of the evaluation is changed for the study, until after they have responded to the questionnaire.

Detailed description

All participants 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 participant time to consider study participation in order to avoid delays the morning of surgery. The morning of surgery the participant 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 participant that minor changes are being made in an attempt to improve the participant experience, but limited information will be shared to reduce potential bias that might result from the participant knowing what is being studied.

Conditions

• Communication
• Patient Satisfaction

Interventions

Type	Name	Description
DEVICE	Clear Mask	The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.

Timeline

• Start date: 2021-11-16
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2021-10-22
• Last updated: 2024-07-29
• Results posted: 2024-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study