Virtual Therapy as a Method Supporting the Cardiac Rehabilitation

Not Applicable

Completed

• Conditions: Depressive Symptoms; Stress; Cardiovascular Diseases; Anxiety State; Coronary Artery Disease; Mood Disorders
• Interventions: Behavioral: Cardiac rehabilitation; Device: Virtual therapeutic support; Behavioral: Standard therapeutic support

• Registration Number: NCT04045977
• Lead Sponsor: Wroclaw University of Health and Sport Sciences

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.

Study Timeline

• Study Start: 2019-06-06
• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-06
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-27
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR therapy group	Cardiac rehabilitation	Cardiac rehabilitation supplemented by VR therapy
Control Group	Cardiac rehabilitation	Cardiac rehabilitation supplemented by Schultz Autogenic Training
VR therapy group	Virtual therapeutic support	Cardiac rehabilitation supplemented by VR therapy
Control Group	Standard therapeutic support	Cardiac rehabilitation supplemented by Schultz Autogenic Training

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)	15 minutes	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 Outcome Measures

Name	Time	Method
Perception of Stress Questionnaire (PSQ)	30 minutes	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.

Trial Locations

Locations (2)

University School of Physical Education; 🇵🇱 Wroclaw, Dolnośląskie, Poland

Centrum Kardiologiczne Pro Corde Sp. z o.o.; 🇵🇱 Wrocław, Dolnośląskie, Poland