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

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001489
• Other study ID #: NL2023.22.265
• Status: Recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Sulayman el Mathari, MD
• Phone: +31628156982
• Email: s.elmathari[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 by Oudkerk Pool et al. (2022) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Cardiac Valve Disease
• Heart Valve Diseases
• Mitral Valve Disease
• Tricuspid Valve Disease

Intervention

Behavioral:
• 360-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 Test:
• State Trait Anxiety Inventory
Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.
• Amsterdam Preoperative Anxiety and Information Scale
This validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State-Anxiety at baseline	State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during outpatient clinic visit prior to surgery	During outpatient clinic visit, prior to surgery
Primary	Trait-Anxiety at baseline	Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during outpatient clinic visit prior to surgery	During outpatient clinic visit, prior to surgery
Primary	Trait-Anxiety at follow-up	Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during admission to hospital (1 day prior to surgery)	1 day prior to surgery
Primary	State-Anxiety at follow-up	State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during admission to hospital (1 day prior to surgery)	1 day prior to surgery
Primary	Need-for-information at baseline	Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery	During outpatient clinic visit, prior to surgery
Primary	Need-for-information at follow-up	Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery	1 day prior to surgery
Primary	Pre-procedural anxiety at baseline	Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery	During outpatient clinic visit, prior to surgery
Primary	Pre-procedural anxiety at follow-up	Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery	1 day prior to surgery
Primary	HR at baseline	Heartrate in bpm (beats per minute) during outpatient clinic visit prior to surgery	During outpatient clinic visit, prior to surgery
Primary	HR at follow-up	Heartrate in bpm (beats per minute) during admission to hospital (1 day prior to surgery)	1 day prior to surgery
Primary	HR in OR	Heartrate in bpm (beats per minute) in the OR on the day of surgery	in the OR on the day of surgery
Primary	Diastolic blood pressure at baseline	Diastolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery	During outpatient clinic visit prior to surgery
Primary	Systolic blood pressure at baseline	Systolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery	During outpatient clinic visit prior to surgery
Primary	Diastolic blood pressure at follow-up	Diastolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)	1 day prior to surgery
Primary	Systolic blood pressure at follow-up	Systolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)	1 day prior to surgery
Primary	Diastolic blood pressure in OR	Systolic blood pressure (in mm/Hg) in the OR on the day of surgery	in the OR on the day of surgery