3D Printed Models in Mohs Micrographic Surgery

Not Applicable

Completed

Conditions: Mohs Micrographic Surgery

Interventions: Behavioral: 3D printed model
Behavioral: Verbal Counselling

Registration Number: NCT03461965

Lead Sponsor: Case Comprehensive Cancer Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 82

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education with 3D printed model	3D printed model	The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model
Education with 3D printed model	Verbal Counselling	The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model
Verbal Counselling	Verbal Counselling	Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script

Primary Outcome Measures

Name	Time	Method
Percent of Correct and Incorrect Mohs Quiz Responses	Post surgery (1 day)	This is an in-house-designed, short questionnaire with 6 multiple choice objective questions related to the participant's understanding of Mohs. A higher percentage of correct answers indicate a better understanding of Mohs. Reported data are percent of responses answered correctly and incorrectly totaled across all participants in each arm

Secondary Outcome Measures

Name	Time	Method
Change in State-Trait Anxiety Inventory (STAI) Y-1 (State Anxiety) Score	From baseline to post surgery (1 day)	The STAI is a well-known, frequently used measure of patient anxiety within the clinical setting. This form consists of two forms to assess state anxiety (Y-1) and a participant's baseline trait anxiety (Y-2). The Y-1 form consists of 20 Likert-type questions with scores ranging from 20 to 80, with higher scores indicating higher anxiety. Reported values are change in "state anxiety' (post-stage minus baseline)
Change in Visual Analog Scale (VAS) Anxiety Score	From baseline to post surgery (1 day)	The VAS is a frequently employed Likert-type scale that is used to measure anxiety. This 0-10 scale documents the patients current state of anxiety, with higher scores indicating worse anxietey, and can be answered by patients with an average reading level. Estimated time of completion is under 30 seconds. This form has been used in 2 studies to date and previously by experimental team to assess intraoperative anxiety in Mohs.
Change in Visual Analog Scale (VAS) Understanding Score	From baseline to post surgery (1 day)	The VAS is a frequently employed Likert-type scale that because of the ease of use this tool has been converted to assess other objective measures including understanding. This 0-10 scale documents the participant's current state of understanding, with higher scores indicating better understanding, and can be answered by patients with an average reading level. Estimated time of completion is under 30 seconds. This form has been used by experimental team to assess intraoperative understanding in Mohs.
Satisfaction Survey Score	Post surgery (1 day)	Participants were provided 3 subjective questions related to their satisfaction with the explanation of MMS that they received. This scale included questions regarding satisfaction with their explanation of the MMS procedure, if the explanation used could be improved, and if they recommended other patients be provided a similar explanation of MMS, with each question scored from 1 to 5, with higher scores indicating greater satisfaction. Total score range is 0 to 15, with higher scores indicating greater satisfaction.