Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06001489
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-08-14
Brief Title:
The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None