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CompletedNCT06241534

Supporting Methods in Cardiovascular Diseases Rehabilitation

Evaluation of the Effectiveness of Modern Technologies in Psychologically-enhanced Rehabilitation in Patients With Cardiovascular Diseases

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Wroclaw University of Health and Sport Sciences · Academic / Other
Sex
All
Age
40 Years – 85 Years
Healthy volunteers
Not accepted

Summary

The study evaluates how various therapeutic approaches perform in addressing depression, anxiety symptoms, and stress levels among patients in the second stage of cardiac rehabilitation. This study aims to evaluate the influence of the used therapeutic approaches on psychological outcomes and to compare the effectiveness of these therapies.

Detailed description

Depression, anxiety, and high levels of perceived stress are increasingly common problems associated with cardiovascular disease (CVD). The relationship between anxiety-depressive disorders and the risk of CVD is confirmed by behavioral and physiological mechanisms. According to the American Heart Association, depression is a negative prognostic factor at all stages of treatment of CVD. The most important risks in people with CVD and anxiety-depressive disorders, as comorbidities, are an increased risk of recurrent cardiovascular events and increased mortality. However, psychological disorders in patients with CVD are still not sufficiently diagnosed and, consequently, are not adequately treated. Therefore, it is necessary to look for effective methods to support cardiac rehabilitation from a psychological perspective. The first group of patients will receive relaxation-therapeutic recordings (referred to as the Recording Group) in addition to monitored cardiac physical training. The second group will receive virtual reality (VR) therapy (referred to as the VR Group) alongside monitored cardiac physical training. The third group (referred to as the Control Group) will receive Schultz Autogenic Training as a standard supplement to cardiological training. The aims of the study: 1. The evaluation of the influence of relaxation-therapeutic recordings on the anxiety-depressive symptoms and the stress level of the patients undergoing second stage of cardiac rehabilitation. 2. The comparison of the effectiveness of therapeutic recordings with the effectiveness of VR therapy and Schultz Autogenic Training.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCardiac rehabilitationFour weeks of cardiac rehabilitation conducted in an outpatient care facility. Three times per week (80 minutes per day) cardiologically monitored aerobic training consisting of: 40 minutes of interval training on a cycloergometer and 40 minutes of general fitness exercises.
BEHAVIORALRelaxation-therapeutic recordings8 sessions of relaxation-therapeutic recordings in the non-sleep deep rest concept. The content of the recording is based on the 'body scanning technique', which constitutes the core of the therapy. This approach aims to quiet the overactive sympathetic part of the autonomic nervous system. During therapy, the patients take a 'journey' through their own body from feet to head. Following the voice of the narrator, the patient focuses on specific body parts, tries to feel this place and then relaxes tense muscles. Relaxation of individual body parts (muscle groups) is combined with breathing exercises. Conscious and mindful breathing deepens the state of relaxation. Additionally, the recording includes therapeutic suggestions related to making a choice between: overload and relief, holding on and letting go, acting and sensing. Furthermore, suggestions focus the patient on inner wisdom that allows them to make the best decisions.
DEVICEVirtual reality therapy8 sessions of VR therapy (each of them 20 minutes long). As a virtual reality source, VR TierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach.The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation.
BEHAVIORALSchultz Autogenic Training8 sessions of Schultz Autogenic Training (each of them 20 minutes long).

Timeline

Start date
2024-02-01
Primary completion
2024-04-15
Completion
2024-05-31
First posted
2024-02-05
Last updated
2024-07-11

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT06241534. Inclusion in this directory is not an endorsement.