The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

Conditions: Mitral Valve Disease; Aortic Valve Disease; Tricuspid Valve Disease; Cardiac Valve Disease

Treatments: Diagnostic Test: Amsterdam Preoperative Anxiety and Information Scale; Diagnostic Test: State Trait Anxiety Inventory; Behavioral: 360-degree Virtual Reality Patient Tour

Study type: Interventional

Funder types: Other

Identifiers

NCT06001489

NL2023.22.265

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients awaiting elective cardiac surgery involving a sternotomy
• 18 years or older

Exclusion criteria

• Under the age of 18
• History of previous cardiac surgery
• (concomitant) aortic surgery
• Cardiac surgery for congenital heart defects
• Hearing or visual impairments
• Language barriers (inability to understand, speak or read Dutch)
• History of severe mental or psychiatric disorders

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Control group

Active Comparator group

Description:

This patient group received A standard form of patient education, consisting of oral information and an informative flyer during their outpatient clinic visit. After this visit, patients were asked to fill out 2 validated questionnaires: Spielberger's State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). 1 day prior to surgery, during admission to the hospital, patients were asked to fill out the STAI and APAIS again.

Treatment:

Diagnostic Test: State Trait Anxiety Inventory

Diagnostic Test: Amsterdam Preoperative Anxiety and Information Scale

Intervention group - VR

Experimental group

Description:

This patient group first received a standard form of patient education, consisting of oral information and an informative flyer. Additionally, patients watched a 360-degree VR Tour using a Pico G2 4K VR headset, describing their entire clinical pathway in more detail. After this visit, patients were asked to fill out 2 validated questionnaires: Spielberger's State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). 1 day prior to surgery, during admission to the hospital, patients were asked to fill out the STAI and APAIS again.

Treatment:

Behavioral: 360-degree Virtual Reality Patient Tour

Diagnostic Test: State Trait Anxiety Inventory

Diagnostic Test: Amsterdam Preoperative Anxiety and Information Scale