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

Not Applicable

• Conditions: Cardiac Resynchronization Therapy Devices; Mindfulness Training; Depression; Perceived Stress; Resilience, Psychological; Anxiety
• Interventions: Behavioral: mindfulness-based intervention; Other: CIED procedure routine care

• Registration Number: NCT06021236
• Lead Sponsor: Chien Chih-Yin

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.

Study Timeline

• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-01
• Study Start: 2024-01-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mindfulness-based intervention and routine care	mindfulness-based intervention	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.
The control group received the CIED procedure routine care	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.
mindfulness-based intervention and routine care	CIED procedure 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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

MacKay Junior College of Medicine, Nursing and Management; 🇨🇳 Taipei, Taiwan