Clinical trial NCT03461965: 3D Printed Models in Mohs Micrographic Surgery
Official title: The Use of 3D Printed Models in Mohs Micrographic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mohs Micrographic Surgery
Keywords: 3D printing
Patient education
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2018-03-12
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be recruited from University Hospitals Department of Dermatology MMS Clinics at the Cleveland Medical Center, Chagrin Highlands and Westlake Locations. These patients will be randomly assigned to a control (50%) or experimental group (50%) prior to the onset of the study protocol.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients undergoing Mohs micrographic surgery (MMS) frequently experience anxiety. It has been suggested that enhanced patient education prior to the procedure may decrease patient anxiety. The purpose of the study is to investigate if optimized participant education enhances participant understanding, decreases participant anxiety and increases participant satisfaction.

Detailed description: 1. To investigate if participant education with a 3 dimensional printed (3DP) MMS model and standardized script protocol increases participant understanding of MMS more than current standard of care (control group) at the University Hospitals Cleveland Medical Center MMS Clinics.
2. To investigate if participant education with a 3DP MMS model and standardized script protocol decreases perioperative participant anxiety during MMS more than current standard of care (control group) at the University Hospitals Cleveland Medical Center MMS Clinics.
3. To evaluate if participant satisfaction with a 3DP MMS model and standardized script protocol increases participant satisfaction during MMS more than current standard of care (control group) at the University Hospitals Cleveland Medical Center MMS Clinics.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing MMS at University Hospitals Cleveland Medical Center, Chagrin Highlands and Westlake Campus
* Capable of reading and completing all subjective questionnaires

Exclusion Criteria:

* Cannot complete the survey measures independently for any reason

Primary outcomes:
measure: Percent of Correct and Incorrect Mohs Quiz Responses
timeFrame: Post surgery (1 day)
Secondary outcomes:
measure: Change in State-Trait Anxiety Inventory (STAI) Y-1 (State Anxiety) Score
timeFrame: From baseline to post surgery (1 day)
measure: Change in Visual Analog Scale (VAS) Anxiety Score
timeFrame: From baseline to post surgery (1 day)
measure: Change in Visual Analog Scale (VAS) Understanding Score
timeFrame: From baseline to post surgery (1 day)
measure: Satisfaction Survey Score
timeFrame: Post surgery (1 day)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Margaret Mann, MD
role: PRINCIPAL_INVESTIGATOR
References: