The Use of 3D Printed Models in Mohs Micrographic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Percent of Correct and Incorrect Mohs Quiz Responses
研究概览
简要总结
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.
详细描述
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing MMS at University Hospitals Cleveland Medical Center, Chagrin Highlands and Westlake Campus
- •Capable of reading and completing all subjective questionnaires
排除标准
- •Cannot complete the survey measures independently for any reason
研究组 & 干预措施
Education with 3D printed model
The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model
干预措施: 3D printed model (Behavioral)
Education with 3D printed model
The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model
干预措施: Verbal Counselling (Behavioral)
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
干预措施: Verbal Counselling (Behavioral)
结局指标
主要结局
Percent of Correct and Incorrect Mohs Quiz Responses
时间窗: 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
次要结局
- Change in State-Trait Anxiety Inventory (STAI) Y-1 (State Anxiety) Score(From baseline to post surgery (1 day))
- Change in Visual Analog Scale (VAS) Anxiety Score(From baseline to post surgery (1 day))
- Change in Visual Analog Scale (VAS) Understanding Score(From baseline to post surgery (1 day))
- Satisfaction Survey Score(Post surgery (1 day))