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

Study Overview
=================
Brief 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.

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

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

Intervention / Treatment
-----------------
* Behavioral: mindfulness-based intervention
* Other: CIED procedure routine care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving implanted cardiac devices for the first time (including cardiac defibrillator ICD and Pacemaker). Adults over 20 years old. Those who have clear consciousness and can communicate in Chinese and Taiwanese. Score of 8 or above on the Hospital Anxiety or Depression Scale. Barthel Index above 70 points. Exclusion Criteria: Diagnosed with dementia by a physician. Diagnosed with mental disorders, including cognitive disorders, organic psychosis and affective psychosis. Patients who have been diagnosed with cancer. Long-term bed ridden.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mindfulness-based intervention and routine care<br>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<br>* Diet meditation breath awareness body scan mindfulness yoga Compassionate blessing<br>* Other names: mindfulness-based intervention with CIED procedure routine care;Other: CIED procedure routine care<br>* CIED procedure home care guidance<br>|
| Other: The control group received the CIED procedure routine care<br>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<br>* CIED procedure home care guidance<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | This study used the Hospital Anxiety and Depression Scale (HADS) to assess anxiety in patients. This scale provides anxiety (HADS-A) scores. | 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. | 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. | 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. | From enrollment to the end of treatment at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index | weight and height will be combined to report BMI in kg/m^2 | 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. | 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. | From enrollment to the end of treatment at 6 months |