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

NCT ID: NCT06001489

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-31

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.

Conditions

Cardiac Valve Disease; Aortic Valve Disease; Mitral Valve Disease; Tricuspid Valve Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

State Trait Anxiety Inventory

Intervention Type: DIAGNOSTIC_TEST

Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.

Amsterdam Preoperative Anxiety and Information Scale

Intervention Type: DIAGNOSTIC_TEST

This validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.

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.

Group Type: EXPERIMENTAL

360-degree Virtual Reality Patient Tour

Intervention Type: BEHAVIORAL

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).

State Trait Anxiety Inventory

Intervention Type: DIAGNOSTIC_TEST

Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.

Amsterdam Preoperative Anxiety and Information Scale

Intervention Type: DIAGNOSTIC_TEST

This validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.

Interventions

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).

Intervention Type: BEHAVIORAL

State Trait Anxiety Inventory

Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

STAI; APAIS

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Jolanda Kluin

Professor of Cardiothoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jolanda Kluin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

j.kluin@amsterdamumc.nl

Locations

Academic Medical Center

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Sulayman el Mathari, MD

Role: CONTACT

s.elmathari@amsterdamumc.nl

+31628156982

Facility Contacts

Sulayman El Mathari, MD

Role: primary

s.elmathari@amsterdamumc.nl

+31 205668188

Other Identifiers

NL2023.22.265

Identifier Type: -

Identifier Source: org_study_id