Clinical trial NCT04045977: Virtual Therapy as a Method Supporting the Cardiac Rehabilitation
Official title: Evaluation of the Effectiveness of Immersive Virtual Reality Therapy as a Method Supporting the Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Artery Disease
Depressive Symptoms
Mood Disorders
Anxiety State
Stress
Keywords: virtual reality
cardiac rehabilitation
psychotherapy
cardiac surgery
depression
anxiety
stress
elderly
Coronary Artery Disease
Ischemic Heart Disease
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: Foundation for Senior Citizen Activation SIWY DYM
First posted: 2019-08-06
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 15 minutes
Secondary outcomes:
measure: Perception of Stress Questionnaire (PSQ)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: University School of Physical Education
state: Dolnośląskie
city: Wrocław
country: Poland
facility: Centrum Kardiologiczne Pro Corde Sp. z o.o.
state: Dolnośląskie
Study officials:
affiliation: University School of Physical Education, Poland
name: Joanna Szczepańska-Gieracha, Prof
role: STUDY_DIRECTOR
affiliation: University School of Physical Education, Poland
name: Joanna Szczepańska-Gieracha, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University School of Physical Education, Poland
name: Sandra Jóźwik
role: STUDY_CHAIR
References:
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citation: Maples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138.
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citation: Szczepanska-Gieracha J, Morka J, Kowalska J, Kustrzycki W, Rymaszewska J. The role of depressive and anxiety symptoms in the evaluation of cardiac rehabilitation efficacy after coronary artery bypass grafting surgery. Eur J Cardiothorac Surg. 2012 Nov;42(5):e108-14. doi: 10.1093/ejcts/ezs463. Epub 2012 Aug 19.
citation: Thompson T, Steffert T, Steed A, Gruzelier J. A randomized controlled trial of the effects of hypnosis with 3-D virtual reality animation on tiredness, mood, and salivary cortisol. Int J Clin Exp Hypn. 2011 Jan;59(1):122-42. doi: 10.1080/00207144.2011.522917.
citation: Szczepanska-Gieracha J, Jozwik S, Cieslik B, Mazurek J, Gajda R. Immersive Virtual Reality Therapy as a Support for Cardiac Rehabilitation: A Pilot Randomized-Controlled Trial. Cyberpsychol Behav Soc Netw. 2021 Aug;24(8):543-549. doi: 10.1089/cyber.2020.0297. Epub 2021 Feb 11.