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NCT Number: NCT04313777

Virtual Reality Therapy in Cardiology

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

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Key information

Conditions

Cardiovascular Diseases Anxiety Anxiety Disorders Arterial Occlusive Diseases Arteriosclerosis Behavior Behavioral Symptoms Coronary Artery Disease Coronary Disease Depression Depressive Symptoms Heart Diseases Mental Disorders Mood Disorders Myocardial Ischemia Stress Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centrum Kardiologiczne Pro Corde Sp. z o.o., Wroclaw, Lower Silesian Voivodeship, Poland

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About this study

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 cardiovascular diseases, allowing restoration of independence in daily functioning. Psychological support is required in order to reduce the negative psychological symptoms related to the heart disease. 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 (VR goggles) 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 aims of the project:

  • The evaluation of the influence of VR therapy on the depressive symptoms and the anxiety level of the patients undergoing second stage of cardiac rehabilitation.
  • The evaluation of the influence of VR therapy on the stress level of the patients undergoing second stage of cardiac rehabilitation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Coronary Artery Disease;
  • the second stage of cardiac rehabilitation conducted in outpatient settings;

Exclusion criteria

  • cognitive impairment (MMSE<24);
  • inability to self-complete the research questionnaires;
  • presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
  • initiation of psychiatric treatment during the research project;
  • contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
  • the patient's refusal at any stage of the research project.

Treatment and study plan

Cardiac rehabilitation

Behavioral

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.

Virtual therapeutic support

Device

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.

Schultz Autogenic Training

Behavioral

8 sessions of Schultz Autogenic Training (each of them 20 minutes long).

Primary outcomes

  1. Change in depressed mood and anxiety from baseline

    Time frame: At baseline and after 8 sessions of VR therapy (week 3)

    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.

Secondary outcomes

  1. Change in perception of stress from baseline

    Time frame: At baseline and after 8 sessions of VR therapy (week 3)

    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.

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Collaborators

  • Foundation for Senior Citizen Activation SIWY DYM

Registry information

Official study title

The Evaluation of Virtual Reality Therapy Efficacy in the Treatment of Depressive and Anxiety Symptoms in Patients With Coronary Artery Disease

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 18, 2020
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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