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Clinical Trials/NCT05688540
NCT05688540CompletedNot Applicable

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 site in 1 country36 target enrollmentStarted: February 19, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
Chinese 14-item PSS

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 93 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

e book

Experimental

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

Intervention: e book (Other)

traditional education booklet

Experimental

traditional education booklet of CIED intervention.

Intervention: traditional education booklet (Other)

Outcomes

Primary Outcomes

Chinese 14-item PSS

Time Frame: 10mins

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

Taiwan Depression Scale

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Miao Yen Chen

RN PhD Professor

National Taipei University of Nursing and Health Sciences

Study Sites (1)

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