An interventional study of mindfulness-based intervention and CIED procedure routine care in Mindfulness Training, Cardiac Resynchronization Therapy Devices and Resilience, Psychological, sponsored by Chien Chih-Yin. Terminated at 1 site in Taiwan. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Chien Chih-Yin · Not applicable, Interventional, and Supportive care
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 34 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
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Exclusion Criteria:
mindfulness-based intervention including: breathing awareness, body scanning, mindful yoga, mindful eating, and loving-kindness meditation. From the time when the patients signed up to be the first to receive the cardiac device surgery schedule, the experimental group that met the including criteria, in addition to following the routine care of the hospital, was involved in teaching the above mindfulness skills, and Osaka continued to follow the regular care.
Behavioral: mindfulness-based intervention · Other: CIED procedure routine care
From the time when the patients signed up to be the first to receive the cardiac device surgery schedule, the control group that met the including criteria take routine care of the hospital.
Other: CIED procedure routine care
Diet meditation breath awareness body scan mindfulness yoga Compassionate blessing
Also known as: mindfulness-based intervention with CIED procedure routine care
CIED procedure home care guidance
Anxiety
This study used the Hospital Anxiety and Depression Scale (HADS) to assess anxiety in patients. This scale provides anxiety (HADS-A) scores.
Time frame: From enrollment to the end of treatment at 6 months
Resilience
This study uses the Connor-Davidson Resilience Scale (Connor-Davidson Resilience Scale), which was developed by Connor and Davidson (2003) in the United States who regarded resilience as a measurable stress response ability.
Time frame: From enrollment to the end of treatment at 6 months
Perceived Stress
This study uses the Perceived Stress Scale, which was compiled by Cohen et al. (1983) and translated from the Chinese version of Chu and Gao (2005). , the degree of stress in life.
Time frame: From enrollment to the end of treatment at 6 months
Depression
This study used the Hospital Anxiety and Depression Scale (HADS) to assess depression in patients. This scale provides anxiety (HADS-D) scores.
Time frame: From enrollment to the end of treatment at 6 months
Demographic Information
Collect age, gender, education level, marital status, occupation, smoking, drinking, disease history, other disease history, and exercise habits with self-made basic data sheets.
Time frame: From enrollment to the end of treatment at 6 months
body mass index
weight and height will be combined to report BMI in kg/m\^2
Time frame: From enrollment to the end of treatment at 6 months
Feelings and experiences by interview of home-based cardiac device patients receiving pre-procedure mindfulness intervention program
Intentional sampling with phenomenological method. Conduct one-on-one interview recordings for the research subjects in the experimental group to collect the feelings and experiences of patients with implanted cardiac devices who received the mindfulness-based preoperative intervention program. It is expected to close the case until the data is saturated.
Time frame: From enrollment to the end of treatment at 6 months
Plan to share: No — The research data belongs to the researcher and is expected to be destroyed after 2 years
This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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