Virtual Therapy as a Method Supporting the Cardiac Rehabilitation

NCT ID: NCT04045977

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2019-10-30

Brief Summary

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.

Detailed Description

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:

1. 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.

2. The evaluation of the influence of VR therapy on the stress level of the patients undergoing second stage of cardiac rehabilitation.

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Depressive Symptoms; Mood Disorders; Anxiety State; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR therapy group

Cardiac rehabilitation supplemented by VR therapy

Group Type: EXPERIMENTAL

Cardiac rehabilitation

Intervention Type: 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

Intervention Type: 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. 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.

Control Group

Cardiac rehabilitation supplemented by Schultz Autogenic Training

Group Type: ACTIVE_COMPARATOR

Cardiac rehabilitation

Intervention Type: 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.

Standard therapeutic support

Intervention Type: BEHAVIORAL

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

Interventions

Cardiac rehabilitation

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.

Intervention Type: BEHAVIORAL

Virtual therapeutic support

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.

Intervention Type: DEVICE

Standard therapeutic support

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Coronary Artery Disease;
• the second stage of cardiac rehabilitation conducted in outpatient settings;
• anxiety symptoms scored 8 and more in HADS-A or depressive symptoms scored 8 and more in HADS-D.

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Senior Citizen Activation SIWY DYM

OTHER

Sponsor Role: collaborator

Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role: lead

Responsible Party

Joanna Szczepańska-Gieracha

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joanna Szczepańska-Gieracha, Prof

Role: STUDY_DIRECTOR

University School of Physical Education, Poland

Joanna Szczepańska-Gieracha, Prof

Role: PRINCIPAL_INVESTIGATOR

University School of Physical Education, Poland

Sandra Jóźwik

Role: STUDY_CHAIR

University School of Physical Education, Poland

Locations

University School of Physical Education

Wroclaw, Lower Silesian Voivodeship, Poland

Centrum Kardiologiczne Pro Corde Sp. z o.o.

Wroclaw, Lower Silesian Voivodeship, Poland

Countries

Poland

References

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Reference Type: DERIVED

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Other Identifiers

59/0203/S/01

Identifier Type: -

Identifier Source: org_study_id