Cardiac Valve Disease, Aortic Valve Disease, Mitral Valve Disease, Tricuspid Valve Disease
Conditions
Brief 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.
Detailed 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.
Interventions
BEHAVIORAL360-degree Virtual Reality Patient Tour
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).
DIAGNOSTIC_TESTState Trait Anxiety Inventory
Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.
DIAGNOSTIC_TESTAmsterdam Preoperative Anxiety and Information Scale
This validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
Prior to visiting the outpatient clinic, patients are unaware about their allocation. Only after their outpatient clinic visit, patients are informed about whether they belong to the control or intervention group. The surgeon, nurses OR assistants, however, are not informed about the treatment allocation. This is only known to the investigators and outcomes assessors.
Intervention model description
This prospective, single-center, randomized controlled trial (RCT) includes patients awaiting elective open heart surgery via a sternotomy. Patients who met the inclusion criteria were invited to participate in the study. Patients were allocated randomly to either the control or intervention group. The control group received oral information from the treating cardiothoracic surgeon. The intervention group received additional information through an educational 360-degree semi-immersive Virtual Reality (VR) Tour. The VR Tour provided patients a comprehensive visual experience of the entire clinical pathway of the scheduled surgical procedure, Patients complete two validated questionnaires immediately following their outpatient clinic visit to assess pre-procedural anxiety. This data was considered the 'baseline'. One day prior to the surgery, during the hospital admission, patients are asked to complete the same questionnaires again. This data will be referred to as 'follow-up (FU)'.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic blood pressure in OR | in the OR on the day of surgery | Systolic blood pressure (in mm/Hg) in the operation room on the day of surgery |
| Systolic blood pressure at baseline | During outpatient clinic visit prior to surgery | Systolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery |
| Diastolic blood pressure at follow-up | 1 day prior to surgery | Diastolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery) |
| Systolic blood pressure at follow-up | 1 day prior to surgery | Systolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery) |
| State-Anxiety at baseline | During outpatient clinic visit, prior to surgery | 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 | During outpatient clinic visit, prior to surgery | 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 | 1 day prior to surgery | 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 | 1 day prior to surgery | 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. |
| Need-for-information at baseline | During outpatient clinic visit, prior to surgery | Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety. |
| Need-for-information at follow-up | 1 day prior to surgery | Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety. |
| Pre-procedural anxiety at baseline | During outpatient clinic visit, prior to surgery | Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety. |
| Pre-procedural anxiety at follow-up | 1 day prior to surgery | Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety. |
| HR at baseline | During outpatient clinic visit, prior to surgery | Heartrate in bpm (beats per minute) during outpatient clinic visit prior to surgery |
| HR at follow-up | 1 day prior to surgery | Heartrate in bpm (beats per minute) during admission to hospital (1 day prior to surgery) |
| HR in operation room | in the OR on the day of surgery | Heartrate in bpm (beats per minute) in the operation room on the day of surgery |
| Diastolic blood pressure at baseline | During outpatient clinic visit prior to surgery | Diastolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery |
Countries
Netherlands
Contacts
Primary ContactSulayman el Mathari, MD
Outcome results
None listed