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临床试验/NCT04413383
NCT04413383已完成不适用

Do Patients Undergoing Dermatologic Surgery Prefer the Use of Traditional Curved Iris Scissors or the Wuennenberg Modified Curved Iris Scissors?

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2020年12月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
147
试验地点
1
主要终点
Extent that patient notices curved Iris scissors

研究概览

简要总结

Every year thousands of dermatologic surgery procedures are performed at the University of Missouri Department of Dermatology, including Mohs Micrographic Surgery (MMS), Excisions, and biopsies. Surgery is known to cause anxiety for patients and with these procedures performed under local anesthetic on awake patients', the sights, sounds, and smells experienced during the procedure can lead to an increase in their anxiety or affect their overall perception of the experience. From performing and assisting with dermatologic surgery the noise associated with the use of the traditional curved Iris scissors provokes an increase in patient awareness to the procedure resulting in increased anxiety, triggering of the vasovagal response, and expressions of annoyance by the patient. However, the modified curved Iris scissors make almost no noise. The Investigators hypothesize that if patients were given the comparative experience of both types of curved Iris scissors during dermatologic surgery, then they will choose the modified curved Iris scissors because the lack of noise will be perceived as more pleasant experience. Our objective is to perform a prospective, single blinded, randomized controlled trial to determine how the noise of traditional curved Iris scissors vs the silent Wuennenberg modified curved Iris scissors affects patients during dermatologic surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adult (18 years or older)
  • •non-pregnant
  • •patients being treated with Mohs micrographic surgery or excision on the head and neck

排除标准

  • •Patients not meeting above inclusion criteria will be excluded.

研究组 & 干预措施

Traditional Curved Iris Scissors

Active Comparator

The traditional curved Iris scissors are used to during the dermatologic surgery. Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.

干预措施: Traditional Curved Iris Scissors (Other)

Modified Curved Iris Scissors

Experimental

The Wuennenberg modified curved Iris scissors are used during the dermatologic surgery.

Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.

干预措施: Wuennenberg Modified Curved Iris Scissors (Other)

Comparative Experience

Other

Both the traditional and modified curved Iris scissors are used and patients are asked which they prefer. Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.

干预措施: Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors (Other)

结局指标

主要结局

Extent that patient notices curved Iris scissors

时间窗: 3 to 8 hours (length of the patients Mohs Surgery)

Questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient notices the use of the curved iris scissors.

Extent that patient is bothered by the curved Iris scissors

时间窗: 3 to 8 hours (length of the patients Mohs Surgery)

Questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient is bothered by the curved iris scissors.

Patients Preference of curved Iris scissor

时间窗: 3 to 8 hours (length of the patients Mohs Surgery)

Patient is asked during the procedure if they prefer "1," surgeon uses the traditional curved Iris scissors, or "2" and the surgeon uses the Wuennenberg modified curved Iris scissors. The patient indicates their preference by responding "1 or 2." After the procedure the patient completes a questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient notices and is bothered by the curved iris scissors.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Wuennenberg

Resident Physician

University of Missouri-Columbia

研究点 (1)

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