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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 360-degree Virtual Reality Patient Tour

    Behavioral

    A 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 test

    Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.

  • Amsterdam Preoperative Anxiety and Information Scale

    Diagnostic test

    This validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 2 interventions
Group B: Intervention group - VRExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
During outpatient clinic visit, prior to surgery
2

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.

Time frame
During outpatient clinic visit, prior to surgery
3

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.

Time frame
1 day prior to surgery
4

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.

Time frame
1 day prior to surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.