跳至主要内容
临床试验/NCT04254445
NCT04254445Unknown不适用

The Effect of Personalized Custom Training Videos on Patient Engagement in Hospitalized Patients Undergoing Thoracocentesis

GistMed Ltd.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Fulfillment of need for information gap

研究概览

简要总结

Patients planned to undergo a pleural tap will get verbal explanation or watch a personalized guidance video in addition to verbal explanation. Questionnaires will be filled to assess the effect of the video training on understanding, cooperation and anxiety.

详细描述

100 patients with pleural effusion, planned to undergo a diagnostic or therapeutic pleural tap, will be randomized to watch a personalized custom video training, explaining the procedure, in addition to the verbal explanation given by the medical staff, or to get the standard verbal explanation alone. Questionnaires regarding their understanding of the procedure, their feelings and the level of anxiety will be filled before and after the video/verbal explanation, and after the procedure. the study aims to check whether the video training provides better understanding of the procedure, increases cooperation and engagement and decreases anxiety.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients hospitalized in Internal medicine C and D, Tel-Aviv Sourasky Medical Centers
  • Patients with pleural effusion, planned to undergo diagnostic or therapeutic pleural tap
  • Patients who can read and understand the questions
  • Patients who were interested in participating in the clinical trial and signed an informed consent form

排除标准

  • Minors < 18 years of age
  • Pregnant women
  • Patients who cannot read and understand, at the discretion of the investigator
  • Patients which their medical condition does not allow them to undergo the study procedure

结局指标

主要结局

Fulfillment of need for information gap

时间窗: 30 minutes

Improvement of subjective self-assessment of the patient's need of information on the tap procedure following the explanation received, based on the short form of the Quality from Patient Perspective (QPP) measurement. The improvement in the intervention arm will be compared to the one of the control arm

Assessment of Anxiety

时间窗: 30 minutes

Delta of subjective self-assessment on his/her anxiety about the procedure, following the explanation received (using visual scale of 1-100, based on the Visual Analog Scale (VAS)). The reduction of anxiety in the intervention arm will be compared to the one of the control arm

次要结局

  • The need of an active role(30 Minutes)
  • Confidence and Knowledge to take actions(30 minutes)

研究者

发起方
GistMed Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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