- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04313777
Virtual Reality Therapy in Cardiology
The Evaluation of Virtual Reality Therapy Efficacy in the Treatment of Depressive and Anxiety Symptoms in Patients With Coronary Artery Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lower Silesia
-
Wroclaw, Lower Silesia, Poland, 51-612
- University School of Physical Education
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Wrocław, Lower Silesia, Poland, 52-244
- Centrum Kardiologiczne Pro Corde Sp. z o.o.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: VR therapy group
Cardiac rehabilitation supplemented by VR therapy
|
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.
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.
|
ACTIVE_COMPARATOR: Control Group
Cardiac rehabilitation supplemented by Schultz Autogenic Training
|
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.
8 sessions of Schultz Autogenic Training (each of them 20 minutes long).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline and after 8 sessions of VR therapy (week 3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline and after 8 sessions of VR therapy (week 3)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Joanna Szczepańska-Gieracha, Prof., University School of Physical Education in Wroclaw, Poland
- Study Chair: Sandra Jóźwik, MSc., University School of Physical Education in Wroclaw, Poland
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 59/0203/S/03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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