Anxiety, Cardiac Resynchronization Therapy Devices, Depression, Mindfulness Training, Perceived Stress, Resilience, Psychological
Conditions
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.
Interventions
BEHAVIORALmindfulness-based intervention
Diet meditation breath awareness body scan mindfulness yoga Compassionate blessing
OTHERCIED procedure routine care
CIED procedure home care guidance
Sponsors
Chien Chih-Yin
National Taipei University of Nursing and Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | From enrollment to the end of treatment at 6 months | This study used the Hospital Anxiety and Depression Scale (HADS) to assess anxiety in patients. This scale provides anxiety (HADS-A) scores. |
| Resilience | From enrollment to the end of treatment at 6 months | 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. |
| Perceived Stress | From enrollment to the end of treatment at 6 months | 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. |
| Depression | From enrollment to the end of treatment at 6 months | This study used the Hospital Anxiety and Depression Scale (HADS) to assess depression in patients. This scale provides anxiety (HADS-D) scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographic Information | From enrollment to the end of treatment at 6 months | Collect age, gender, education level, marital status, occupation, smoking, drinking, disease history, other disease history, and exercise habits with self-made basic data sheets. |
| body mass index | From enrollment to the end of treatment at 6 months | weight and height will be combined to report BMI in kg/m\^2 |
| Feelings and experiences by interview of home-based cardiac device patients receiving pre-procedure mindfulness intervention program | From enrollment to the end of treatment at 6 months | 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. |
Countries
Taiwan
Contacts
STUDY_CHAIRCY Chien, PI
MKC/MMH
Outcome results
None listed