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

Primary Purpose

Cardiac Valve Disease, Aortic Valve Disease, Mitral Valve Disease

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
360-degree Virtual Reality Patient Tour
State Trait Anxiety Inventory
Amsterdam Preoperative Anxiety and Information Scale
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Valve Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academic Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group - VR

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 14, 2023
Last Updated
August 14, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT06001489
Brief Title
The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
Official Title
The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Valve Disease, Aortic Valve Disease, Mitral Valve Disease, Tricuspid Valve Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)'.
Masking
Care Provider
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention group - VR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
360-degree Virtual Reality Patient Tour
Intervention Description
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
Diagnostic Test
Intervention Name(s)
State Trait Anxiety Inventory
Other Intervention Name(s)
STAI
Intervention Description
Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.
Intervention Type
Diagnostic Test
Intervention Name(s)
Amsterdam Preoperative Anxiety and Information Scale
Other Intervention Name(s)
APAIS
Intervention Description
This validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.
Primary Outcome Measure Information:
Title
State-Anxiety at baseline
Description
State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during outpatient clinic visit prior to surgery
Time Frame
During outpatient clinic visit, prior to surgery
Title
Trait-Anxiety at baseline
Description
Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during outpatient clinic visit prior to surgery
Time Frame
During outpatient clinic visit, prior to surgery
Title
Trait-Anxiety at follow-up
Description
Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during admission to hospital (1 day prior to surgery)
Time Frame
1 day prior to surgery
Title
State-Anxiety at follow-up
Description
State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during admission to hospital (1 day prior to surgery)
Time Frame
1 day prior to surgery
Title
Need-for-information at baseline
Description
Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery
Time Frame
During outpatient clinic visit, prior to surgery
Title
Need-for-information at follow-up
Description
Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery
Time Frame
1 day prior to surgery
Title
Pre-procedural anxiety at baseline
Description
Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery
Time Frame
During outpatient clinic visit, prior to surgery
Title
Pre-procedural anxiety at follow-up
Description
Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery
Time Frame
1 day prior to surgery
Title
HR at baseline
Description
Heartrate in bpm (beats per minute) during outpatient clinic visit prior to surgery
Time Frame
During outpatient clinic visit, prior to surgery
Title
HR at follow-up
Description
Heartrate in bpm (beats per minute) during admission to hospital (1 day prior to surgery)
Time Frame
1 day prior to surgery
Title
HR in OR
Description
Heartrate in bpm (beats per minute) in the OR on the day of surgery
Time Frame
in the OR on the day of surgery
Title
Diastolic blood pressure at baseline
Description
Diastolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery
Time Frame
During outpatient clinic visit prior to surgery
Title
Systolic blood pressure at baseline
Description
Systolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery
Time Frame
During outpatient clinic visit prior to surgery
Title
Diastolic blood pressure at follow-up
Description
Diastolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)
Time Frame
1 day prior to surgery
Title
Systolic blood pressure at follow-up
Description
Systolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)
Time Frame
1 day prior to surgery
Title
Diastolic blood pressure in OR
Description
Systolic blood pressure (in mm/Hg) in the OR on the day of surgery
Time Frame
in the OR on the day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sulayman el Mathari, MD
Phone
+31628156982
Email
s.elmathari@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jolanda Kluin, MD, PhD
Organizational Affiliation
j.kluin@amsterdamumc.nl
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sulayman El Mathari, MD
Phone
+31 205668188
Email
s.elmathari@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Jolanda Kluin, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
When asked for, a construction will be made to share data. At the end of the study.

Learn more about this trial

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

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