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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-30

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized clinical trial design (randomized clinical trial) with qualitative analysis, which is a mixed-methods research. Research objects were randomly assigned to the experimental and control groups in a 1:1 manner. The experimental group received the mindfulness-based intervention designed and routine care, and the control group received usual care. A total of four questionnaires were filled in the pretest (T0), the first month of discharge (T1), the 3rd month of discharge(T2), and the 6th month of discharge (T3), including anxiety, depression, mental toughness, and stress perception. Qualitative interviews were conducted at T2 and T3 to understand the improvement of psychological problems.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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mindfulness-based intervention and routine care

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.

Group Type EXPERIMENTAL

mindfulness-based intervention

Intervention Type BEHAVIORAL

Diet meditation breath awareness body scan mindfulness yoga Compassionate blessing

CIED procedure routine care

Intervention Type OTHER

CIED procedure home care guidance

The control group received the 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.

Group Type OTHER

CIED procedure routine care

Intervention Type OTHER

CIED procedure home care guidance

Interventions

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mindfulness-based intervention

Diet meditation breath awareness body scan mindfulness yoga Compassionate blessing

Intervention Type BEHAVIORAL

CIED procedure routine care

CIED procedure home care guidance

Intervention Type OTHER

Other Intervention Names

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mindfulness-based intervention with CIED procedure routine care

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No