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NCT Number: NCT06001489

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location status: Recruiting

Location contact

Jolanda Kluin, MD, PhD

PRINCIPAL_INVESTIGATOR

Sulayman El Mathari, MD

CONTACT

[email protected]

+31 205668188

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

360-degree Virtual Reality Patient Tour

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

Diagnostic Test

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

Other names: STAI

Amsterdam Preoperative Anxiety and Information Scale

Diagnostic Test

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

Other names: APAIS

Primary outcomes

  1. State-Anxiety at baseline

    Time frame: During outpatient clinic visit, prior to surgery

    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.

  2. Trait-Anxiety at baseline

    Time frame: During outpatient clinic visit, prior to surgery

    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.

  3. Trait-Anxiety at follow-up

    Time frame: 1 day prior to surgery

    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.

  4. State-Anxiety at follow-up

    Time frame: 1 day prior to surgery

    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.

  5. Need-for-information at baseline

    Time frame: During outpatient clinic visit, prior to surgery

    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.

  6. Need-for-information at follow-up

    Time frame: 1 day prior to surgery

    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.

  7. Pre-procedural anxiety at baseline

    Time frame: During outpatient clinic visit, prior to surgery

    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.

  8. Pre-procedural anxiety at follow-up

    Time frame: 1 day prior to surgery

    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.

  9. HR at baseline

    Time frame: During outpatient clinic visit, prior to surgery

    Heartrate in bpm (beats per minute) during outpatient clinic visit prior to surgery

  10. HR at follow-up

    Time frame: 1 day prior to surgery

    Heartrate in bpm (beats per minute) during admission to hospital (1 day prior to surgery)

  11. HR in operation room

    Time frame: in the OR on the day of surgery

    Heartrate in bpm (beats per minute) in the operation room on the day of surgery

  12. Diastolic blood pressure at baseline

    Time frame: During outpatient clinic visit prior to surgery

    Diastolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery

  13. Systolic blood pressure at baseline

    Time frame: During outpatient clinic visit prior to surgery

    Systolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery

  14. Diastolic blood pressure at follow-up

    Time frame: 1 day prior to surgery

    Diastolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)

  15. Systolic blood pressure at follow-up

    Time frame: 1 day prior to surgery

    Systolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)

  16. Diastolic blood pressure in OR

    Time frame: in the OR on the day of surgery

    Systolic blood pressure (in mm/Hg) in the operation room on the day of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Sulayman el Mathari, MD

CONTACT

[email protected]

+31628156982

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2023
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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