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临床试验/NCT04291807
NCT04291807已完成不适用

Determining the Effect of Video Assisted Education on Anxiety Level and Satisfaction Before ERCP Procedure

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Change in anxiety status of the patients after ERCP

研究概览

简要总结

It was aimed to study the effect of video assisted education about endoscopic retrograde cholangiopancreaticography (ERCP) on anxiety levels of patients who planned to undergo ERCP for any reason.Video revealing the ERCP procedure was shown to the patients in one group and not shown to the other. Then anxiety levels and pain scores have been obtained before and after the procedure in both groups

详细描述

The study was conducted to determine the effect of video education on anxiety level before the ERCP procedure and satisfaction degree after the ERCP procedure between September 1st 2017 and December 31st 2018 at Bagcilar Medipol Mega University Hospital. Patients were grouped into two in a randomized manner. In control arm, patients underwent ERCP procedure with the information provided by the gastroenterologist who recommended the procedure. Patients in experimental arm, besides the information provided by the gastroenterologist, watched video of ERCP procedure and answered all the questions about the procedure by an experienced nurse. A total of 70 patients (35 in each arms) was planned to enroll to the study. State-Trait Anxiety Inventory (STAI) form was applied to measure anxiety level and visual analog score (VAS) was applied to measure the satisfaction about the procedure.

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
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

入选标准

  • Over 18 years old
  • Conscious enough to understand the procedure and education
  • Patients who can read
  • Hemodynamically stable patients
  • Mentally stable patients
  • Patients who gave informed consent

排除标准

  • Patients who underwent previous ERCP procedure

结局指标

主要结局

Change in anxiety status of the patients after ERCP

时间窗: an hour before ERCP and an hour after ERCP

This will be measured with Stait Trait Anxiety Inventory. There are 2 subscales within this measure. The State Anxiety Scale (S-Anxiety) evaluates the current state of anxiety, asking how respondents feel "right now," using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. The Trait Anxiety Scale (T-Anxiety) evaluates relatively stable aspects of "anxiety proneness," including general states of calmness, confidence, and security. The STAI has 40 items, 20 items allocated to each of the subscales. Responses for the S-Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the T-Anxiety scale assess frequency of feelings "in general": 1) almost never, 2) sometimes, 3) often, and 4) almost always. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety.

次要结局

  • Satisfaction assessed by visual analogue scale(an hour after ERCP)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

leylacevik

Research Nurse

Istanbul Medipol University Hospital

研究点 (1)

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