Virtual Therapy as a Method Supporting the Cardiac Rehabilitation

Coronary Artery Disease Clinical Trial

Official title:

Evaluation of the Effectiveness of Immersive Virtual Reality Therapy as a Method Supporting the Cardiac Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04045977
• Other study ID #: 59/0203/S/01
• Status: Completed
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: November 2019
• Source: University School of Physical Education in Wroclaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety State
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Depression
• Depressive Symptoms
• Mood Disorders
• Myocardial Ischemia
• Stress

Intervention

Behavioral:
• 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.

Device:
• 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.

Behavioral:
• Standard therapeutic support
8 sessions of Schultz Autogenic Training (each of them 20 minutes long).

Locations

Country	Name	City	State
Poland	Centrum Kardiologiczne Pro Corde Sp. z o.o.	Wroclaw	Dolnoslaskie
Poland	University School of Physical Education	Wroclaw	Dolnoslaskie

Sponsors (2)

Lead Sponsor	Collaborator
University School of Physical Education in Wroclaw	Foundation for Senior Citizen Activation SIWY DYM

Country where clinical trial is conducted

Poland, 

References & Publications (7)

Freeman D, Reeve S, Robinson A, Ehlers A, Clark D, Spanlang B, Slater M. Virtual reality in the assessment, understanding, and treatment of mental health disorders. Psychol Med. 2017 Oct;47(14):2393-2400. doi: 10.1017/S003329171700040X. Epub 2017 Mar 22. Review. — View Citation

Li J, Theng YL, Foo S. Game-based digital interventions for depression therapy: a systematic review and meta-analysis. Cyberpsychol Behav Soc Netw. 2014 Aug;17(8):519-27. doi: 10.1089/cyber.2013.0481. Epub 2014 May 8. Review. — View 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. Review. — View Citation

McCann RA, Armstrong CM, Skopp NA, Edwards-Stewart A, Smolenski DJ, June JD, Metzger-Abamukong M, Reger GM. Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. J Anxiety Disord. 2014 Aug;28(6):625-31. doi: 10.1016/j.janxdis.2014.05.010. Epub 2014 Jun 7. Review. — View 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. — View 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. — View Citation

Valmaggia LR, Latif L, Kempton MJ, Rus-Calafell M. Virtual reality in the psychological treatment for mental health problems: An systematic review of recent evidence. Psychiatry Res. 2016 Feb 28;236:189-195. doi: 10.1016/j.psychres.2016.01.015. Epub 2016 Jan 12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes
Secondary	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.	30 minutes