Psychometric and Physiological Assessment of the Effects of Vir-tual Reality in Cardiovascular Rehabilitation

NCT07195279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-26

No results posted yet for this study

Summary

Virtual reality (VR) is a high-end user-computer interface involving real-time stimulation and interaction of an embedded subject through visual and auditory sensorial channels, based on a synthetic environment in which the subject feels to be present. Over the past few decades, VR has been extensively used in psychological and neuroscientific research, as well as clinical applications, yielding promising results for diverse clinical conditions. Furthermore, VR has also been employed in the cardiovascular field across various settings, including cardiac rehabilitation, interventional cardiology, and cardiac surgery, to assess both physiological and psychological outcomes.

The benefits of using VR may stem from its ability to be customized, potentially enhancing the rehabilitation experience by offering cognitive, emotional, and physical advantages. It can improve patients' motivation and engagement, reduce anxiety. In general, in the context of cardiac rehabilitation, the impact of VR appears to be more closely linked to improvements in mental health, particularly in relation to psychological aspects such as mood enhancement, stress reduction, and increased emotional well-being. These benefits may be due to the immersive and engaging nature of VR, which can provide a sense of novelty, distraction from discomfort, and a greater feeling of control over the rehabilitation process. However, current evidence does not clearly demonstrate its superiority over conventional approaches in other important outcomes, including treatment adherence, patient satisfaction, and overall quality of life. The aim of this study was to test the efficacy of integrating the use of a VR system based on driving simulation in cardiac rehabilitation through a randomized controlled trial.

Conditions

  • Cardiac Rehabilitation

Interventions

OTHER

Experimental Group

The VR intervention consisted of a simulated driving experience delivered over nine sessions, three times per week, each lasting 20 minutes, over a three-week period. The virtual reality (VR) therapy employed a full immersion approach, delivering intense multisensory visual-auditory stimulation. Patients were exposed to diverse driving scenarios, specifically: urban streets (featuring intersections, traffic lights, and pedestrians to simulate complex urban environments), ring roads (designed for practicing smooth and confident high-speed driving in dense traffic), and tunnels (sections aimed at gradually desensitizing users to claustrophobic responses during driving).

OTHER

Control Group

Conventional cardiac rehabilitation protocol consisted of 1.5-hour group calisthenics sessions with a 10-minute break, held six times per week. This was accompanied by aerobic reconditioning exercises on a stationary bike or treadmill, depending on medical prescription and the patient's health status.

Sponsors & Collaborators

  • University of Roma La Sapienza

    collaborator OTHER
  • I.R.C.C.S. Fondazione Santa Lucia

    lead OTHER

Principal Investigators

  • Marco Iosa, PhD, Associate Professor · IRRCS Santa Lucia foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-07
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07195279 on ClinicalTrials.gov