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

NCT06001489 | Recruiting DMC

• 1 other identifier: NL2023.22.265
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (16)

• 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 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

• 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 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

• 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

Study Arms (2)

Control group

ACTIVE COMPARATOR

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; Diagnostic Test: Amsterdam Preoperative Anxiety and Information Scale

Intervention group - VR

EXPERIMENTAL

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.

Behavioral: 360-degree Virtual Reality Patient Tour; Diagnostic Test: State Trait Anxiety Inventory; Diagnostic Test: Amsterdam Preoperative Anxiety and Information Scale

Interventions

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).

Intervention group - VR

State Trait Anxiety Inventory DIAGNOSTIC_TEST

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

Also known as: STAI

Control group; Intervention group - VR

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.

Also known as: APAIS

Control group; Intervention group - VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients awaiting elective cardiac surgery involving a sternotomy
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jolanda Kluin, MD, PhD

  j.kluin@amsterdamumc.nl

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sulayman el Mathari, MD

CONTACT

+31628156982; s.elmathari@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Prior to visiting the outpatient clinic, patients are unaware about their allocation. Only after their outpatient clinic visit, patients are informed about whether they belong to the control or intervention group. The surgeon, nurses OR assistants, however, are not informed about the treatment allocation. This is only known to the investigators and outcomes assessors.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiothoracic Surgery

Model Details: This prospective, single-center, randomized controlled trial (RCT) includes patients awaiting elective open heart surgery via a sternotomy. Patients who met the inclusion criteria were invited to participate in the study. Patients were allocated randomly to either the control or intervention group. The control group received oral information from the treating cardiothoracic surgeon. The intervention group received additional information through an educational 360-degree semi-immersive Virtual Reality (VR) Tour. The VR Tour provided patients a comprehensive visual experience of the entire clinical pathway of the scheduled surgical procedure, Patients complete two validated questionnaires immediately following their outpatient clinic visit to assess pre-procedural anxiety. This data was considered the 'baseline'. One day prior to the surgery, during the hospital admission, patients are asked to complete the same questionnaires again. This data will be referred to as 'follow-up (FU)'.

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: July 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

NL (1)