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

Not Applicable

Completed

• Conditions: Cardiac Implantable Electronic Device
• Interventions: Other: e book; Other: traditional education booklet

• Registration Number: NCT05688540
• Lead Sponsor: National Taipei University of Nursing and Health Sciences

Brief Summary

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

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

Study Timeline

• Study Start: 2019-02-19
• Primary Completion: 2022-03-18
• Study Completion: 2022-03-18
• Study First Submitted: 2023-01-07
• Study First Submitted QC: 2023-01-07
• Study First Posted: 2023-01-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
e book	e book	a multi-media model through e-book for preoperative care of CIED intervention.
traditional education booklet	traditional education booklet	traditional education booklet of CIED intervention.

Primary Outcome Measures

Name	Time	Method
Chinese 14-item PSS	10mins	14 questions totally for measuring the stress of patient in a month.
Taiwan Depression Scale	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)	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.

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan