Efficiency of Electronic Multimedia Intervention With the Cardiac Implantable Electronic Device.

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Cardiac Implantable Electronic Device

Intervention / Treatment
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* Other: e book
* Other: traditional education booklet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: TDS > score 19 (Severely depressed patient) Patient of terminal stage cancer. Patient with delirium during hospitalization.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 93 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: e book<br>a multi-media model through e-book for preoperative care of CIED intervention. | Other: e book<br>* e book<br>|
| Experimental: traditional education booklet<br>traditional education booklet of CIED intervention. | Other: traditional education booklet<br>* traditional education booklet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHOQOL-BREF(TW) | 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. | 20mins | 
| Chinese 14-item PSS | 14 questions totally for measuring the stress of patient in a month. | 10mins | 
| Taiwan Depression Scale | 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. | 10mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac implantable electronic device, quality of life, electronic multimedia, psychological adjustment