An interventional study of Cardiac rehabilitation and Virtual therapeutic support in Cardiovascular Diseases, Coronary Artery Disease and Depressive Symptoms, sponsored by Wroclaw University of Health and Sport Sciences. Completed at 2 sites in Poland. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-12-03.
Sponsored by Wroclaw University of Health and Sport Sciences · Not applicable, Interventional, and Treatment
This study evaluates the effectiveness of virtual reality (VR) therapy in the treatment of depression and anxiety symptoms in patients undergoing second stage of cardiac rehabilitation. Half of the study group will receive VR therapy (VR group) as an addition to cardiologically monitored physical training. The other half of the group (control group) will receive Schultz Autogenic Training as a standard supplement to cardiological training.
Cardiologically monitored physical training in second stage of cardiac rehabilitation leads to the improvement in the physical capacity and overall fitness of the patients with Coronary Artery Disease, allowing restoration of independence in daily functioning. Psychological support is required in order to reduce the negative psychological symptoms related to both the heart disease itself and the cardiac surgery performed. In this study the investigators want to assess the effectiveness of the virtual reality (VR) therapy compared to standard psychological support (Schultz Autogenic Training).
Thanks to using head mounted display and the phenomenon of total immersion VR therapy allows to completely separate the patient from the hospital environment, provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or, in another part of the therapy, it can motivate the patient to the rehabilitation process. The additional aim of the VR therapy is to help the patients regain their emotional balance, let them recognize their psychological resources and trigger the natural recovery mechanisms.
The goals of the project:
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's enrollment of 34 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Wroclaw University of Health and Sport Sciences is the lead sponsor of 46 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Cardiac rehabilitation supplemented by VR therapy
Behavioral: Cardiac rehabilitation · Device: Virtual therapeutic support
Cardiac rehabilitation supplemented by Schultz Autogenic Training
Behavioral: Cardiac rehabilitation · Behavioral: Standard therapeutic support
Four 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.
8 sessions of VR therapy (each of them 20 minutes long). As a virtual reality source, VR Tier One 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. By performing tasks in the virtual garden, the patient becomes an active participant of the therapeutic process and sees the effects his/her work.
8 sessions of Schultz Autogenic Training (each of them 20 minutes long).
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.
Time frame: 15 minutes
Perception of Stress Questionnaire (PSQ)
The Perception of Stress Questionnaire (PSQ) is a 27-item scale scoring from 1 to 5 for each item. 21 items examine the level of stress in the area of emotional tension, external stress and intrapsychic stress, and 6 items refer to the lie scale. The global scoring for perception of stress ranges from 21 to 105 with a cut-off point of 60 for high level of perceived stress. The higher the score, the greater the sense of stress. PSQ will be performed at the beginning and after four weeks of treatment.
Time frame: 30 minutes
Plan to share: No
Ran from Jun 2019 to primary completion in Sep 2019, 3 months.
Of 1,032 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 3 months is below that.
Counting every sponsor, half of 1,148 studies reached it within 26 months; a quarter within 13 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Wroclaw University of Health and Sport Sciences