Clinical Trials Logo

Clinical Trial Summary

Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time. Adequate patient education can help diminish pre-procedural anxiety and minimize postoperative complications. Recent studies have demonstrated that Virtual Reality (VR) can function as a useful tool to diminish pre-procedural anxiety in several medical fields. Especially 360 degree VR could familiarize patients with their clinical pathway. Nevertheless, limited to no research on the application of 360 degree VR has been conducted in the context of cardiothoracic surgery yet. Objective: The aim of this study is to explore the effects and possible benefits of 360 degree VR on pre-procedural anxiety in patients awaiting elective cardiac surgery involving a sternotomy, compared to standard forms of patient education. Study design: Single-center, randomized controlled trial Study population: Patients aged 18 or older awaiting elective cardiac surgery involving a sternotomy.


Clinical Trial Description

Patients undergoing cardiothoracic surgery are inclined to experience a form of pre-procedural anxiety. Not only can these feelings of concern cause huge psychological discomfort for patients awaiting surgery, but this can also translate into somatic complications, especially for patients with coronary artery disease. These adverse events include a prolonged recovery time, increased risk of re-hospitalization and death amongst other implications and underline the necessity of addressing pre-procedural anxiety. Several approaches have been introduced in an attempt to contain these feelings of concern. Examples that have been applied in the field of surgery include pharmacological interventions as well as extensive patient education. Especially the latter has recently been proven to be effective in diminishing pre-procedural anxiety. A recent study by Oudkerk Pool et al. (2022) highlighted the significance of 360-degree Virtual Reality patient education in limiting pre-procedural anxiety levels in patients undergoing percutaneous atrial septal closure. Their research demonstrated that thorough patient education using VR could prevent elevated scores of anxiety, possibly contributing to a diminished number of adverse events in this patient group. Alongside this study, several other researches have hinted at success or are investigating the benefit of VR in managing anxiety levels. Considering these promising results, the aim of the VR Patient Journey Trial is to evaluate the additional value of 360-degree Virtual Reality as a new modality in reducing pre-procedural anxiety in comparison with regular forms of patient education in patients undergoing coronary artery bypass grafting (CABG) procedures. This procedure remains the most performed type of cardiac surgery and accounts for a large homogenous patient group; an estimated 85% of procedures concern isolated CABG. Managing anxiety levels in this patient group can therefore greatly impact the overall level of patient well-being in cardiac surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06001489
Study type Interventional
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Sulayman el Mathari, MD
Phone +31628156982
Email s.elmathari@amsterdamumc.nl
Status Recruiting
Phase N/A
Start date September 2023
Completion date December 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04149600 - Identification of Genetic Causes of Calcific Aortic Valve Disease
Not yet recruiting NCT04430972 - Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
Completed NCT02467062 - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease. N/A
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
Terminated NCT02128841 - Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve. Phase 2
Active, not recruiting NCT01194362 - A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease
Not yet recruiting NCT05975567 - Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
Recruiting NCT06025149 - The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Completed NCT05082337 - The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures N/A
Completed NCT05193760 - Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Not yet recruiting NCT05941455 - A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve N/A
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Active, not recruiting NCT03924661 - SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
Completed NCT04073875 - 18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis
Recruiting NCT03121053 - Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement Phase 4
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Completed NCT02981004 - PAR I - Patient-to-Annulus Relation I
Completed NCT02688153 - EDWARDS INTUITY Valve System CADENCE Study N/A
Recruiting NCT06126367 - Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease
Active, not recruiting NCT05082454 - Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)