Ventricular Tachycardia Clinical Trial
Official title:
Efficacy of Mindfulness Training on the Quality of Life of Patients With Implantable Automatic Defibrillator
Verified date | November 2019 |
Source | Instituto de Investigación Hospital Universitario La Paz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The general objective of the study was to evaluate the impact of two emotional regulation
programs, one standardized and face-to-face (MBSR: Mindfulness Based Stress Reduction) and,
another, implemented through a mobile phone application (REM_Volver a casa; ERBM_Back home:
Emotional Regulation Based on Mindfulness), on the quality of life, the state emotional and
psychological and biological variables associated with stress, in a sample of patients with
ICD (implantable cardioverter defibrillator).
The working hypotheses were that after training in emotional regulation, patients with ICD
would have better quality of life, lower symptoms of anxiety, depression and hostility, and
lower incidence of ventricular arrhythmias than patients in the control group, as well as
that there would be no differences between the two tools used for training.
Status | Completed |
Enrollment | 96 |
Est. completion date | May 30, 2018 |
Est. primary completion date | February 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Age equal to or greater than 18 years. - Be a patient of the University Hospital La Paz and have an ICD implanted whose implant was equal to or greater than three months. - Sufficient knowledge of the Spanish language. - Have a mobile phone and the ability to handle applications on the phone. - Availability and sufficient physical conditions to attend mindfulness training in the face-to-face format. Exclusion Criteria: - Be over 75 years old. - Be waiting for a heart transplant or other operation related to cardiac pathology. - Have previous training in mindfulness, unless it had been done before 5 years and had not been practiced since then. - Being diagnosed with a serious mental disorder and being in an acute symptomatic period of the disease. |
Country | Name | City | State |
---|---|---|---|
Spain | La Paz University Hospital | Madrid |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Hospital Universitario La Paz |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mindfulness attitude | FFMQ: Five Facet Mindfulness Questionnaire. In this questionnaire five factors of mindfulness ability are collected: Observe, from 8 to 40 points; Describe, from 8 to 40 points; Act consciously, from 8 to 40 points; Not judge, from 8 to 40 points; and, Not react, from 7 to 35 points. | The data corresponding to the mindfulness attitude measured just before starting the mindfulness training program and, eight weeks later, after finishing it. | |
Primary | Health Related Quality of Life | The questionnaire (SF-36: Short Form) uses a Likert scale of 3 or 5 points, with a range of scores from 0 to 100, average of 50 and standard deviation 10. | In order to assess the change at the Quality of life variable, was measured just before starting the mindfulness training program and, eight weeks later, after finishing it. | |
Secondary | Anxiety and Depression | HADS: Hospital Anxiety and Depression Scale. This scale assess the presence of anxiety or depression. It consists of two sub-scales, of 7 items each, are scored on a Likert scale of 4 points. The cut-off points used for the two scales were: 0 to 7 = no clinical significance; from 8 to 10 = doubtful; from 11 to 14 = moderate; from 15 to 21 = severe. | In order to assess the change at the anxiety and depression variables, were measured just before starting the mindfulness training program and, eight weeks later, after finishing it. | |
Secondary | Anger | STAXI: State-Trait Anger Expression Inventory. Questionnaire used to evaluate the expression of hostility, in terms of personality trait and regarding the circumstantial state at the time of measurement. The scores are represented in standardized T scores: mean of 50 points and a standard deviation of 10 points. | In order to assess the change at the Anger variable, was measured just before starting the mindfulness training program and, eight weeks later, after finishing it. | |
Secondary | AHR | Average Heart Rate (AHR).These parameters were obtained from the data record of the defibrillator implanted in each patient, and is quantified by beats per minute. | To assess the change in the AHR variable, the data collected corresponded to the two months before the intervention and the two months after the intervention. | |
Secondary | NSVT | Number of Non-Sustained Ventricular Tachycardia (NSVT). These parameters were obtained from the data record of the defibrillator implanted in each patient, and is quantified by whole numbers. | To assess the change in the NSVT variable, the data collected corresponded to the two months before the intervention and the two months after the intervention. | |
Secondary | LVEF | Left Ventricular Ejection Fraction (LVEF). The ejection fraction is the force with which the left ventricle contracts and is related to the patient's prognosis and its symptomatology. This parameter is classified into four levels, according to the percentage. Less than 40%: heart failure. From 40 to 55%: below normal heart function. From 55 to 70%: normal heart function. Higher than 75%: can indicate a heart condition. |
The value of this parameter is recorded at the beginning of the study. | |
Secondary | FC | Functional Class (FC). The functional class for dyspnea is a classification according to the degree to which patients have the feeling of shortness of breath. The functional classification is determined according to the following four levels: Without any limitation of physical activity. Slight limitation of physical activity. Marked limitation of physical activity. Inability to carry out any physical activity without symptoms. |
The value of this parameter is recorded at the beginning of the study. | |
Secondary | Number of Shocks | Number of shocks produced by the implantable automatic defibrillator, in each patient. Events (shocks) are determined by their registration in the device (implantable automatic defibrillator). The device has a record in which it stores parameters related to the functioning of the heart and the regulation and control processes performed by the device, among them, the shocks it gives in order to restore a situation of ventricular fibrillation or ventricular arrhythmia. This parameter is quantified by whole numbers. | The estimated period of evaluation is up to 8 years. The events (shocks) accounted are for the period between the date of implantation of the device and the date of the last data collection, approximately 33 months after the start of the study. | |
Secondary | Daily Activity | Number of daily hours of activity, recorded by the implantable automatic defibrillator device. This parameter is quantified in hours. | To assess the change in the Daily Activity variable, the data collected corresponded to the two months before the intervention and the two months after the intervention. |
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