Efficacy of a Mindfulness-Based Intervention in Patients With Cardiovascular Implantable Electronic Device (MBI-CIED)

Chien Chih-Yin

Status: Invitation-only

Conditions: Cardiac Resynchronization Therapy Devices; Resilience, Psychological; Depression; Mindfulness Training; Anxiety; Perceived Stress

Treatments: Other: CIED procedure routine care; Behavioral: mindfulness-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06021236

MKC-23MMHIS220e

23MMHIS220e (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients receiving implanted cardiac devices for the first time (including cardiac defibrillator ICD and Pacemaker).
2. Adults over 20 years old.
3. Those who have clear consciousness and can communicate in Chinese and Taiwanese.
4. Score of 8 or above on the Hospital Anxiety or Depression Scale.
5. Barthel Index above 70 points.

Exclusion criteria

1. Diagnosed with dementia by a physician.
2. Diagnosed with mental disorders, including cognitive disorders, organic psychosis and affective psychosis.
3. Patients who have been diagnosed with cancer.
4. Long-term bed ridden.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

mindfulness-based intervention and routine care

Experimental group

Description:

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.

Treatment:

Behavioral: mindfulness-based intervention

Other: CIED procedure routine care

The control group received the CIED procedure routine care

Other group

Description:

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.

Treatment:

Other: CIED procedure routine care