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Virtual Therapy as a Method Supporting the Cardiac Rehabilitation

Primary Purpose

Cardiovascular Diseases, Coronary Artery Disease, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Cardiac rehabilitation
Virtual therapeutic support
Standard therapeutic support
Sponsored by
Wroclaw University of Health and Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring virtual reality, cardiac rehabilitation, psychotherapy, cardiac surgery, depression, anxiety, stress, elderly, Coronary Artery Disease, Ischemic Heart Disease

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University School of Physical Education
  • Centrum Kardiologiczne Pro Corde Sp. z o.o.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VR therapy group

Control Group

Arm Description

Cardiac rehabilitation supplemented by VR therapy

Cardiac rehabilitation supplemented by Schultz Autogenic Training

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 31, 2019
Last Updated
November 27, 2019
Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
Foundation for Senior Citizen Activation SIWY DYM
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1. Study Identification

Unique Protocol Identification Number
NCT04045977
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
Foundation for Senior Citizen Activation SIWY DYM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR therapy group
Arm Type
Experimental
Arm Description
Cardiac rehabilitation supplemented by VR therapy
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Cardiac rehabilitation supplemented by Schultz Autogenic Training
Intervention Type
Behavioral
Intervention Name(s)
Cardiac rehabilitation
Intervention Description
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
Device
Intervention Name(s)
Virtual therapeutic support
Intervention Description
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
Behavioral
Intervention Name(s)
Standard therapeutic support
Intervention Description
8 sessions of Schultz Autogenic Training (each of them 20 minutes long).
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Perception of Stress Questionnaire (PSQ)
Description
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.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Szczepańska-Gieracha, Prof
Organizational Affiliation
University School of Physical Education, Poland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joanna Szczepańska-Gieracha, Prof
Organizational Affiliation
University School of Physical Education, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Jóźwik
Organizational Affiliation
University School of Physical Education, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
University School of Physical Education
City
Wroclaw
State/Province
Dolnośląskie
ZIP/Postal Code
51-612
Country
Poland
Facility Name
Centrum Kardiologiczne Pro Corde Sp. z o.o.
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
52-244
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24810933
Citation
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Results Reference
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PubMed Identifier
25093964
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.
Results Reference
background
PubMed Identifier
28475502
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.
Results Reference
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PubMed Identifier
28325167
Citation
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.
Results Reference
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PubMed Identifier
26795129
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.
Results Reference
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PubMed Identifier
22906598
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.
Results Reference
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PubMed Identifier
21104488
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.
Results Reference
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PubMed Identifier
33577375
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.
Results Reference
derived

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Virtual Therapy as a Method Supporting the Cardiac Rehabilitation

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