Clinical trial NCT06001489: The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
Official title: The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Valve Disease
Aortic Valve Disease
Mitral Valve Disease
Tricuspid Valve Disease
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)'.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: State-Anxiety at baseline
timeFrame: During outpatient clinic visit, prior to surgery
measure: Trait-Anxiety at baseline
timeFrame: During outpatient clinic visit, prior to surgery
measure: Trait-Anxiety at follow-up
timeFrame: 1 day prior to surgery
measure: State-Anxiety at follow-up
timeFrame: 1 day prior to surgery
measure: Need-for-information at baseline
timeFrame: During outpatient clinic visit, prior to surgery
measure: Need-for-information at follow-up
timeFrame: 1 day prior to surgery
measure: Pre-procedural anxiety at baseline
timeFrame: During outpatient clinic visit, prior to surgery
measure: Pre-procedural anxiety at follow-up
timeFrame: 1 day prior to surgery
measure: HR at baseline
timeFrame: During outpatient clinic visit, prior to surgery
measure: HR at follow-up
timeFrame: 1 day prior to surgery
measure: HR in operation room
timeFrame: in the OR on the day of surgery
measure: Diastolic blood pressure at baseline
timeFrame: During outpatient clinic visit prior to surgery
measure: Systolic blood pressure at baseline
timeFrame: During outpatient clinic visit prior to surgery
measure: Diastolic blood pressure at follow-up
timeFrame: 1 day prior to surgery
measure: Systolic blood pressure at follow-up
timeFrame: 1 day prior to surgery
measure: Diastolic blood pressure in OR
timeFrame: in the OR on the day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord Holland
Study officials:
affiliation: j.kluin@amsterdamumc.nl
name: Jolanda Kluin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: