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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Implantable Electronic Device
• Intervention / Treatment: Other: e book; Other: traditional education booklet

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 93 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Collaborators: Mackay Memorial Hospital
• Investigators: Principal Investigator: Yen Chen CHEN, PhD, National Taipei University of Nursing and Health Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Actual): March 18, 2022
• Study Completion (Actual): March 18, 2022

Study Registration Dates

• First Submitted: January 7, 2023
• First Submitted That Met QC Criteria: January 7, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; cardiac implantable electronic device; psychological adjustment; electronic multimedia
• Other Study ID Numbers: 18MMHIS006e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No