跳至主要内容
临床试验/NCT03485937
NCT03485937撤回不适用

Impact of Pre-Operative Videos on Mohs Surgery Patient Anxiety and Satisfaction

Case Comprehensive Cancer Center0 个研究点开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Difference in mean Likert scale rating of subject satisfaction score

研究概览

简要总结

The purpose of this research is to look at how educational videos might affect patient satisfaction and anxiety before Mohs surgery day. Patients will be randomized to either: 1) a group that receives educational videos before the visit in addition to standard-of-care written and verbal instructions OR 2) a group that receives only standard-of-care written and verbal instructions.

详细描述

The primary objective of this study is to determine if pre-operative videos describing the patient's forthcoming day in the Mohs clinic decrease pre-operative patient anxiety and increase postoperative patient satisfaction, when added to standard of care written and verbal instruction.

Design/Study Type This study will be a randomized control trial in which patients will be randomized to either the intervention (pre-operative Mohs Surgery video viewing) or control (standard of care) group in order to understand the impact of the video on patient anxiety and satisfaction. Patients will be randomized using an Accelerated Biased Coin Design in the statistical program R.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who are at the University Hospitals Cleveland Medical Center Mohs Clinic to undergo a linear closure on the face.
  • •Fluent English speakers

排除标准

  • •Non-fluent English speakers

研究组 & 干预措施

Pre-Operative Videos + verbal/written instructions

Experimental

This video contains the same instructions that the patient receives when they arrive at the clinic, as well as a video walk through of the clinic/patient room. Videos will be created by the study team to ensure that the content coincides with what is delivered in the standard-of-care verbal and written instructions.

干预措施: Pre-Operative Videos (Behavioral)

Pre-Operative Videos + verbal/written instructions

Experimental

This video contains the same instructions that the patient receives when they arrive at the clinic, as well as a video walk through of the clinic/patient room. Videos will be created by the study team to ensure that the content coincides with what is delivered in the standard-of-care verbal and written instructions.

干预措施: verbal instructions (Behavioral)

Pre-Operative Videos + verbal/written instructions

Experimental

This video contains the same instructions that the patient receives when they arrive at the clinic, as well as a video walk through of the clinic/patient room. Videos will be created by the study team to ensure that the content coincides with what is delivered in the standard-of-care verbal and written instructions.

干预措施: written instructions (Behavioral)

verbal/written instructions

Active Comparator

This arm will receive the standard-of-care verbal/written instructions and the pre-operative video explanation. These instructions contain the same content as in the pre-operative videos

干预措施: verbal instructions (Behavioral)

verbal/written instructions

Active Comparator

This arm will receive the standard-of-care verbal/written instructions and the pre-operative video explanation. These instructions contain the same content as in the pre-operative videos

干预措施: written instructions (Behavioral)

结局指标

主要结局

Difference in mean Likert scale rating of subject satisfaction score

时间窗: Up to 8 weeks after visit

For subject satisfaction score, the mean Likert scale rating for the control and intervention groups will be compared. The scale being used is a six item instrument with individual scores ranging from 1-5 (total score 6-30). Higher scores indicate greater satisfaction.

Difference in mean Likert scale rating of subject anxiety score

时间窗: Up to 8 weeks after visit

For subject anxiety score, the mean Likert scale rating for the control and intervention groups will be compared. The scale being used is a seven item instrument with individual scores ranging from 1-5 with positive worded items scored in reverse (total score 7-35). Higher scores indicate greater anxiety

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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