Effect of Clear Masks on Patient Satisfaction With Communication

Wake Forest University (WFU)

Status: Completed

Conditions: Patient Satisfaction; Communication

Treatments: Device: Clear Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT05088603

IRB00077199

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Clear Mask

Experimental group

Description:

Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.

Treatment:

Device: Clear Mask

Standard Mask

No Intervention group

Description:

Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.