Virtual Reality Therapy in Cardiology

NCT04313777 | Completed

• 1 other identifier: 59/0203/S/03
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

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

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Depressive Symptoms; Mood Disorders; Anxiety; Stress

Keywords

virtual reality; cardiac rehabilitation; psychotherapy; cardiac surgery; depression; anxiety; stress

Outcome Measures

Primary Outcomes (1)

• Change in depressed mood and anxiety from baseline

  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 Outcomes (1)

• Change in perception of stress from baseline

  At baseline and after 8 sessions of VR therapy (week 3)

Study Arms (2)

VR therapy group

EXPERIMENTAL

Cardiac rehabilitation supplemented by VR therapy

Behavioral: Cardiac rehabilitation; Device: Virtual therapeutic support

Control Group

ACTIVE COMPARATOR

Cardiac rehabilitation supplemented by Schultz Autogenic Training

Behavioral: Cardiac rehabilitation; Behavioral: Schultz Autogenic Training

Interventions

Cardiac rehabilitation BEHAVIORAL

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.

Control Group; VR therapy group

Virtual therapeutic support DEVICE

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.

VR therapy group

Schultz Autogenic Training BEHAVIORAL

8 sessions of Schultz Autogenic Training (each of them 20 minutes long).

Control Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary Artery Disease;
• the second stage of cardiac rehabilitation conducted in outpatient settings;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Foundation for Senior Citizen Activation SIWY DYM: collaborator

Study Sites (2)

University School of Physical Education

Wroclaw, Lower Silesian Voivodeship, 51-612, Poland

Location

Centrum Kardiologiczne Pro Corde Sp. z o.o.

Wroclaw, Lower Silesian Voivodeship, 52-244, Poland

Location

Related Publications (8)

• 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.

  PMID: 24810933 BACKGROUND

• 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.

  PMID: 25093964 BACKGROUND

• 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.

  PMID: 28475502 BACKGROUND

• 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.

  PMID: 28325167 BACKGROUND

• 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.

  PMID: 26795129 BACKGROUND

• 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.

  PMID: 22906598 BACKGROUND

• 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.

  PMID: 21104488 BACKGROUND

• 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.

  PMID: 34741536 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Depression; Mood Disorders; Anxiety Disorders

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Joanna Szczepańska-Gieracha, Prof.

  University School of Physical Education in Wroclaw, Poland

  PRINCIPAL INVESTIGATOR

• Sandra Jóźwik, MSc.

  University School of Physical Education in Wroclaw, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 18, 2020
• Study Start: January 6, 2020
• Primary Completion: March 13, 2020
• Study Completion: April 3, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)