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

March 21, 2024 updated by: Chien Chih-Yin

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chih Yin Chien, PhD Candidates
  • Phone Number: 2234 +886-2-28584180
  • Email: s157@mail.mkc.edu.tw

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11260
        • MacKay Junior College of Medicine, Nursing and Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: mindfulness-based intervention
Diet meditation breath awareness body scan mindfulness yoga Compassionate blessing
Other Names:
  • mindfulness-based intervention with CIED procedure routine care
Other: CIED procedure routine care
CIED procedure home care guidance
Other: 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.
Other: CIED procedure routine care
CIED procedure home care guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 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.
From enrollment to the end of treatment at 6 months
Resilience
Time Frame: 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.
From enrollment to the end of treatment at 6 months
Perceived Stress
Time Frame: 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.
From enrollment to the end of treatment at 6 months
Depression
Time Frame: 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.
From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Information
Time Frame: 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.
From enrollment to the end of treatment at 6 months
body mass index
Time Frame: From enrollment to the end of treatment at 6 months
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
Time Frame: 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.
From enrollment to the end of treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chien Chih-Yin

Collaborators

National Taipei University of Nursing and Health Sciences

Investigators

  • Study Chair: CY Chien, PI, MKC/MMH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

June 29, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKC-23MMHIS220e
  • 23MMHIS220e (Registry Identifier: CYChien)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The research data belongs to the researcher and is expected to be destroyed after 2 years

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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