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临床试验/NCT05688540
NCT05688540已完成不适用

Efficiency of Electronic Multimedia Intervention on Quality of Life, Psychological Adjustment and Depression in Patients With the Cardiac Implantable Electronic Device

National Taipei University of Nursing and Health Sciences1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年2月19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
36
试验地点
1
主要终点
Chinese 14-item PSS

研究概览

简要总结

In this study, we aim to design a multi-media model through e-book for preoperative care of CIED intervention, which can enhance the knowledges of patients, reducing the stresses and uncertainties before the intervention. Therefore, patient may reduce the psychological internalization after CIED intervention, also needs to track the impact of emotional depression, psychological adaption and life quality status.

详细描述

Arrhythmia is defined an abnormality in the heart transmission system related to heartbeat or heart rhythm problem (Li et al., 2017). Most of arrhythmia could diagnosed and treated effectively, including medication, cardiac implantable electronic device (CIED) and operation. Many patients have uncertainty about the implantation process, the results and possible complications after CIED, the lack of understanding about further progress of their disease, the change of lifestyle and the accident of electronic shock. Those causes are the physical and mental negative impacts on patient which makes anxiety or depressed and turn affects the quality of life.

At present, there are few clinical models for CIED utilizing electronic multi-media in Taiwan. The use of multi-media models may integrate clinical care and health education for helping patients to learn disease and care, also through vivid video and multi-media, we may make a clear education of disease causes, treatment and relevant care knowledges which are alleviate the uncertainty factors from patients (Hsueh et al., 2016). Therefore, the more overall understanding before CIED intervention, the more helpful to quality of living and psychological adjustment of the patient.

In this study, we aim to design a multi-media model through e-book for preoperative care of CIED intervention, which can enhance the knowledges of patients, reducing the stresses and uncertainties before the intervention. Therefore, patient may reduce the psychological internalization after CIED intervention, also needs to track the impact of emotional depression, psychological adaption and life quality status.

keywords:Cardiac Implantable Electronic Device、arrhythmia、electronic multimedia、quality of life、psychological adjustment、depression

研究设计

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

入排标准

年龄范围
20 Years 至 93 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Actual age > 20 years-old adults.
  • •Patients are willing to participate in this research.
  • •Conscious clear, sanity, and be able to communicate with others in Mandarin or Taiwanese languages.
  • •Be able to operate mobile electronic device, such as mobile phone, iPAD or laptop; Families and healthcare provider allows to assist.

排除标准

  • •TDS > score 19 (Severely depressed patient)
  • •Patient of terminal stage cancer.
  • •Patient with delirium during hospitalization.

研究组 & 干预措施

e book

Experimental

a multi-media model through e-book for preoperative care of CIED intervention.

干预措施: e book (Other)

traditional education booklet

Experimental

traditional education booklet of CIED intervention.

干预措施: traditional education booklet (Other)

结局指标

主要结局

Chinese 14-item PSS

时间窗: 10mins

14 questions totally for measuring the stress of patient in a month.

Taiwan Depression Scale

时间窗: 10mins

18 questions totally for testing how level of anxiety and depress of patient. The element of this scale are mental aspect, self-thought aspect and physical aspect.

WHOQOL-BREF(TW)

时间窗: 20mins

28 questions totally with four parts, including physical, mental, social-behavior related and environment aspects. The more score they get, means more quality of life they obtained.

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

Miao Yen Chen

RN PhD Professor

National Taipei University of Nursing and Health Sciences

研究点 (1)

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