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

Cardiac Implantable Electronic Device Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05688540
• Other study ID #: 18MMHIS006e
• Status: Completed
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: March 18, 2022

Study information

• Verified date: November 2023
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 18, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 93 Years

Eligibility

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.

Exclusion Criteria:

1. TDS > score 19 (Severely depressed patient)

2. Patient of terminal stage cancer.

3. Patient with delirium during hospitalization.

Related Conditions & MeSH terms

• Cardiac Implantable Electronic Device

Intervention

Other:
• e book
e book
• traditional education booklet
traditional education booklet

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences	Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Abbasi M, Negarandeh R, Norouzadeh R, Shojae Mogadam AR. The Challenges of Living With an Implantable Cardioverter Defibrillator: A Qualitative Study. Iran Red Crescent Med J. 2016 Jun 22;18(10):e25158. doi: 10.5812/ircmj.25158. eCollection 2016 Oct. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Chinese 14-item PSS	14 questions totally for measuring the stress of patient in a month.	10mins
Primary	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