About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients awaiting elective cardiac surgery involving a sternotomy
18 years or older
Disqualifiers
Under the age of 18
History of previous cardiac surgery
(concomitant) aortic surgery
Cardiac surgery for congenital heart defects
Trial design
Parallel
Treatments tested in this trial
360-degree Virtual Reality Patient Tour
BehavioralA 360-degree video that encompasses the entire clinical pathway. Patients are able to familiarize themselves with the hospital settings (nursery ward, operating room, intensive care unit).
State Trait Anxiety Inventory
Diagnostic testSpielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.
Amsterdam Preoperative Anxiety and Information Scale
Diagnostic testThis validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.
Treatment groups
Trial outcomes
Primary outcomes
State-Anxiety at baseline
State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during outpatient clinic visit prior to surgery. Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Trait-Anxiety at baseline
Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during outpatient clinic visit prior to surgery. Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Trait-Anxiety at follow-up
Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during admission to hospital (1 day prior to surgery). Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
State-Anxiety at follow-up
State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during admission to hospital (1 day prior to surgery). Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Sponsors and contacts
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