NCT06021236

Efficacy of a Mindfulness-Based Intervention in Patients With Cardiovascular Implantable Electronic Device

Efficacy of a Mindfulness-Based Intervention on Resilience, Perceived Stress, Anxiety, and Depression, in Patients With Cardiovascular Implantable Electronic Device: A Mixed-Methods Research

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Chien Chih-Yin · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

An implantable cardiac defibrillator (implantable cardioverter-defibrillator; ICD) can effectively improve heart rhythm problems and reduce sudden death, and is widely used in the treatment of high-risk patients with fatal arrhythmias or heart rhythm problems that cannot be controlled by drugs . In the whole case of arrhythmia, after receiving home-based cardiac fibrillator treatment, Patients often experience uncertainty, feel the changes in heart, feel the shock of being shocked by the electric shock, and worry about death, These psychological distress, which were characterized by anxiety and depression. for universal. About 25% of patients present with symptoms of anxiety at the time of hospitalization, and 50% suffer from depression which seriously affects quality of life. Therefore, the main purpose of this study to alleviate the occurrence of anxiety and depression, promote disease patients to regain life adaptation, develop accessible care strategies with midfulness-based intervention to help patients overcome psychological distress, reduce stress, anxiety and prevent depression.

Detailed description

This study with randomized clinical trial design (randomized clinical trial) and qualitative research, which is a qualitative mixed-methods research. Patients were randomly assigned to the experimental group and the control group in a 1:1 manner. The experimental group received the mindfulness-based intervention designed and routine care , and the control group received general routine care. Both groups completed a total of four questionnaires at the pretest (T0), discharge (T1), the first month of discharge (T2), and the third month of discharge (T3), including anxiety, depression, resilience, stress perception scale and other basic data such as demographics and disease characteristics were collected in the pretest. This study held an expert meeting to extract the techniques of mindfulness measures suitable for this disease attribute and the elderly group, including: breathing awareness, body scanning, mindful yoga, mindful eating, and loving-kindness meditation. From the time when the patient signed up for the first cardiac device surgery schedule, the experimental group who met the including criteria followed the routine care of the hospital and was involved in teaching the above mindfulness skills, while the control group still followed the routine care.

Conditions

• Mindfulness Training
• Cardiac Resynchronization Therapy Devices
• Resilience, Psychological
• Anxiety
• Depression
• Perceived Stress

Interventions

Type	Name	Description
BEHAVIORAL	mindfulness-based intervention	Diet meditation breath awareness body scan mindfulness yoga Compassionate blessing
OTHER	CIED procedure routine care	CIED procedure home care guidance

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-09-01
• Last updated: 2026-04-14

Locations

1 site across 1 country: Taiwan