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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Disease; Cardiac Valve Disease; Mitral Valve Disease; Tricuspid Valve Disease
• Intervention / Treatment: Diagnostic test: State Trait Anxiety Inventory; Diagnostic test: Amsterdam Preoperative Anxiety and Information Scale; Behavioral: 360-degree Virtual Reality Patient Tour

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sulayman el Mathari, MD; Phone Number: +31628156982; Email: s.elmathari@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1105 AZ
      • Recruiting
      • Academic Medical Center
      • Contact: Sulayman El Mathari, MD; Phone Number: +31 205668188; Email: s.elmathari@amsterdamumc.nl
      • Principal Investigator: Jolanda Kluin, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; This patient group received A standard form of patient education, consisting of oral information and an informative flyer during their outpatient clinic visit. After this visit, patients were asked to fill out 2 validated questionnaires: Spielberger's State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). 1 day prior to surgery, during admission to the hospital, patients were asked to fill out the STAI and APAIS again.	Diagnostic test: State Trait Anxiety Inventory; Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.; Other Names: STAI; Diagnostic test: Amsterdam Preoperative Anxiety and Information Scale; This validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.; Other Names: APAIS
Experimental: Intervention group - VR; This patient group first received a standard form of patient education, consisting of oral information and an informative flyer. Additionally, patients watched a 360-degree VR Tour using a Pico G2 4K VR headset, describing their entire clinical pathway in more detail. After this visit, patients were asked to fill out 2 validated questionnaires: Spielberger's State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). 1 day prior to surgery, during admission to the hospital, patients were asked to fill out the STAI and APAIS again.	Diagnostic test: State Trait Anxiety Inventory; Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.; Other Names: STAI; Diagnostic test: Amsterdam Preoperative Anxiety and Information Scale; This validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.; Other Names: APAIS; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HR at baseline	Heartrate in bpm (beats per minute) during outpatient clinic visit prior to surgery	During outpatient clinic visit, prior to surgery
HR at follow-up	Heartrate in bpm (beats per minute) during admission to hospital (1 day prior to surgery)	1 day prior to surgery
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
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
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
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
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.	During outpatient clinic visit, prior to surgery
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.	During outpatient clinic visit, prior to surgery
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.	1 day prior to surgery
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.	1 day prior to surgery
Need-for-information at baseline	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.	During outpatient clinic visit, prior to surgery
Need-for-information at follow-up	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.	1 day prior to surgery
Pre-procedural anxiety at baseline	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.	During outpatient clinic visit, prior to surgery
Pre-procedural anxiety at follow-up	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.	1 day prior to surgery
HR in operation room	Heartrate in bpm (beats per minute) in the operation room on the day of surgery	in the OR on the day of surgery
Diastolic blood pressure in OR	Systolic blood pressure (in mm/Hg) in the operation room on the day of surgery	in the OR on the day of surgery

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Jolanda Kluin, MD, PhD, j.kluin@amsterdamumc.nl

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: NL2023.22.265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: When asked for, a construction will be made to share data. At the end of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No