3D Printed Models in Mohs Micrographic Surgery

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Mohs Micrographic Surgery

Treatments: Behavioral: 3D printed model; Behavioral: Verbal Counselling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03461965

CASE6617

T32AR007569 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Education with 3D printed model

Experimental group

Description:

The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model

Treatment:

Behavioral: Verbal Counselling

Behavioral: 3D printed model

Verbal Counselling

Active Comparator group

Description:

Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script

Treatment:

Behavioral: Verbal Counselling