xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06001489</url>
    </required_header>
    <id_info>
      <org_study_id>NL2023.22.265</org_study_id>
      <nct_id>NCT06001489</nct_id>
    </id_info>
    <brief_title>The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy</brief_title>
    <official_title>The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This&#xD;
        anxiety is associated with increased analgesic needs, increased risk of mortality and&#xD;
        prolonged recovery time. Adequate patient education can help diminish pre-procedural anxiety&#xD;
        and minimize postoperative complications. Recent studies have demonstrated that Virtual&#xD;
        Reality (VR) can function as a useful tool to diminish pre-procedural anxiety in several&#xD;
        medical fields. Especially 360 degree VR could familiarize patients with their clinical&#xD;
        pathway. Nevertheless, limited to no research on the application of 360 degree VR has been&#xD;
        conducted in the context of cardiothoracic surgery yet.&#xD;
  &#xD;
        Objective: The aim of this study is to explore the effects and possible benefits of 360&#xD;
        degree VR on pre-procedural anxiety in patients awaiting elective cardiac surgery involving a&#xD;
        sternotomy, compared to standard forms of patient education.&#xD;
  &#xD;
        Study design: Single-center, randomized controlled trial&#xD;
  &#xD;
        Study population: Patients aged 18 or older awaiting elective cardiac surgery involving a&#xD;
        sternotomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients undergoing cardiothoracic surgery are inclined to experience a form of&#xD;
        pre-procedural anxiety. Not only can these feelings of concern cause huge psychological&#xD;
        discomfort for patients awaiting surgery, but this can also translate into somatic&#xD;
        complications, especially for patients with coronary artery disease. These adverse events&#xD;
        include a prolonged recovery time, increased risk of re-hospitalization and death amongst&#xD;
        other implications and underline the necessity of addressing pre-procedural anxiety. Several&#xD;
        approaches have been introduced in an attempt to contain these feelings of concern. Examples&#xD;
        that have been applied in the field of surgery include pharmacological interventions as well&#xD;
        as extensive patient education. Especially the latter has recently been proven to be&#xD;
        effective in diminishing pre-procedural anxiety.&#xD;
  &#xD;
        A recent study by Oudkerk Pool et al. (2022) highlighted the significance of 360-degree&#xD;
        Virtual Reality patient education in limiting pre-procedural anxiety levels in patients&#xD;
        undergoing percutaneous atrial septal closure. Their research demonstrated that thorough&#xD;
        patient education using VR could prevent elevated scores of anxiety, possibly contributing to&#xD;
        a diminished number of adverse events in this patient group. Alongside this study, several&#xD;
        other researches have hinted at success or are investigating the benefit of VR in managing&#xD;
        anxiety levels.&#xD;
  &#xD;
        Considering these promising results, the aim of the VR Patient Journey Trial is to evaluate&#xD;
        the additional value of 360-degree Virtual Reality as a new modality in reducing&#xD;
        pre-procedural anxiety in comparison with regular forms of patient education in patients&#xD;
        undergoing coronary artery bypass grafting (CABG) procedures. This procedure remains the most&#xD;
        performed type of cardiac surgery and accounts for a large homogenous patient group; an&#xD;
        estimated 85% of procedures concern isolated CABG. Managing anxiety levels in this patient&#xD;
        group can therefore greatly impact the overall level of patient well-being in cardiac&#xD;
        surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_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,&#xD;
  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)'.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Care Provider)</masking>
      <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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>State-Anxiety at baseline</measure>
      <time_frame>During outpatient clinic visit, prior to surgery</time_frame>
      <description>State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during outpatient clinic visit prior to surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trait-Anxiety at baseline</measure>
      <time_frame>During outpatient clinic visit, prior to surgery</time_frame>
      <description>Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during outpatient clinic visit prior to surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trait-Anxiety at follow-up</measure>
      <time_frame>1 day prior to surgery</time_frame>
      <description>Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during admission to hospital (1 day prior to surgery)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>State-Anxiety at follow-up</measure>
      <time_frame>1 day prior to surgery</time_frame>
      <description>State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during admission to hospital (1 day prior to surgery)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Need-for-information at baseline</measure>
      <time_frame>During outpatient clinic visit, prior to surgery</time_frame>
      <description>Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Need-for-information at follow-up</measure>
      <time_frame>1 day prior to surgery</time_frame>
      <description>Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pre-procedural anxiety at baseline</measure>
      <time_frame>During outpatient clinic visit, prior to surgery</time_frame>
      <description>Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pre-procedural anxiety at follow-up</measure>
      <time_frame>1 day prior to surgery</time_frame>
      <description>Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HR at baseline</measure>
      <time_frame>During outpatient clinic visit, prior to surgery</time_frame>
      <description>Heartrate in bpm (beats per minute) during outpatient clinic visit prior to surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HR at follow-up</measure>
      <time_frame>1 day prior to surgery</time_frame>
      <description>Heartrate in bpm (beats per minute) during admission to hospital (1 day prior to surgery)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HR in OR</measure>
      <time_frame>in the OR on the day of surgery</time_frame>
      <description>Heartrate in bpm (beats per minute) in the OR on the day of surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diastolic blood pressure at baseline</measure>
      <time_frame>During outpatient clinic visit prior to surgery</time_frame>
      <description>Diastolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systolic blood pressure at baseline</measure>
      <time_frame>During outpatient clinic visit prior to surgery</time_frame>
      <description>Systolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diastolic blood pressure at follow-up</measure>
      <time_frame>1 day prior to surgery</time_frame>
      <description>Diastolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systolic blood pressure at follow-up</measure>
      <time_frame>1 day prior to surgery</time_frame>
      <description>Systolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diastolic blood pressure in OR</measure>
      <time_frame>in the OR on the day of surgery</time_frame>
      <description>Systolic blood pressure (in mm/Hg) in the OR on the day of surgery</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Cardiac Valve Disease</condition>
    <condition>Aortic Valve Disease</condition>
    <condition>Mitral Valve Disease</condition>
    <condition>Tricuspid Valve Disease</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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).&#xD;
  1 day prior to surgery, during admission to the hospital, patients were asked to fill out the STAI and APAIS again.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention group - VR</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.&#xD;
  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).&#xD;
  1 day prior to surgery, during admission to the hospital, patients were asked to fill out the STAI and APAIS again.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>360-degree Virtual Reality Patient Tour</intervention_name>
      <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).</description>
      <arm_group_label>Intervention group - VR</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>State Trait Anxiety Inventory</intervention_name>
      <description>Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Intervention group - VR</arm_group_label>
      <other_name>STAI</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Amsterdam Preoperative Anxiety and Information Scale</intervention_name>
      <description>This validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Intervention group - VR</arm_group_label>
      <other_name>APAIS</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients awaiting elective cardiac surgery involving a sternotomy&#xD;
  &#xD;
            -  18 years or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Under the age of 18&#xD;
  &#xD;
            -  History of previous cardiac surgery&#xD;
  &#xD;
            -  (concomitant) aortic surgery&#xD;
  &#xD;
            -  Cardiac surgery for congenital heart defects&#xD;
  &#xD;
            -  Hearing or visual impairments&#xD;
  &#xD;
            -  Language barriers (inability to understand, speak or read Dutch)&#xD;
  &#xD;
            -  History of severe mental or psychiatric disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jolanda Kluin, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>j.kluin@amsterdamumc.nl</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sulayman el Mathari, MD</last_name>
      <phone>+31628156982</phone>
      <email>s.elmathari@amsterdamumc.nl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Academic Medical Center</name>
        <address>
          <city>Amsterdam</city>
          <state>Noord Holland</state>
          <zip>1105 AZ</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sulayman El Mathari, MD</last_name>
        <phone>+31 205668188</phone>
        <email>s.elmathari@amsterdamumc.nl</email>
      </contact>
      <investigator>
        <last_name>Jolanda Kluin, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Jolanda Kluin</investigator_full_name>
      <investigator_title>Professor of Cardiothoracic Surgery</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aortic Valve Disease</mesh_term>
      <mesh_term>Heart Valve Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>When asked for, a construction will be made to share data. At the end of the study.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06001489
  org study id: NL2023.22.265
  nct id: NCT06001489
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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)'.
  primary purpose: Supportive Care
  masking: Single (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.
  measure: State-Anxiety at baseline
  time frame: During outpatient clinic visit, prior to surgery
  description: State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during outpatient clinic visit prior to surgery
  measure: Trait-Anxiety at baseline
  time frame: During outpatient clinic visit, prior to surgery
  description: Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during outpatient clinic visit prior to surgery
  measure: Trait-Anxiety at follow-up
  time frame: 1 day prior to surgery
  description: Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during admission to hospital (1 day prior to surgery)
  measure: State-Anxiety at follow-up
  time frame: 1 day prior to surgery
  description: State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory (STAI)) during admission to hospital (1 day prior to surgery)
  measure: Need-for-information at baseline
  time frame: During outpatient clinic visit, prior to surgery
  description: Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery
  measure: Need-for-information at follow-up
  time frame: 1 day prior to surgery
  description: Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery
  measure: Pre-procedural anxiety at baseline
  time frame: During outpatient clinic visit, prior to surgery
  description: Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery
  measure: Pre-procedural anxiety at follow-up
  time frame: 1 day prior to surgery
  description: Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale (APAIS)) during outpatient clinic visit prior to surgery
  measure: HR at baseline
  time frame: During outpatient clinic visit, prior to surgery
  description: Heartrate in bpm (beats per minute) during outpatient clinic visit prior to surgery
  measure: HR at follow-up
  time frame: 1 day prior to surgery
  description: Heartrate in bpm (beats per minute) during admission to hospital (1 day prior to surgery)
  measure: HR in OR
  time frame: in the OR on the day of surgery
  description: Heartrate in bpm (beats per minute) in the OR on the day of surgery
  measure: Diastolic blood pressure at baseline
  time frame: During outpatient clinic visit prior to surgery
  description: Diastolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery
  measure: Systolic blood pressure at baseline
  time frame: During outpatient clinic visit prior to surgery
  description: Systolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery
  measure: Diastolic blood pressure at follow-up
  time frame: 1 day prior to surgery
  description: Diastolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)
  measure: Systolic blood pressure at follow-up
  time frame: 1 day prior to surgery
  description: Systolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)
  measure: Diastolic blood pressure in OR
  time frame: in the OR on the day of surgery
  description: Systolic blood pressure (in mm/Hg) in the OR on the day of surgery
  arm group label: Control group
  arm group type: Active Comparator
  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 group label: Intervention group - VR
  arm group type: Experimental
  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: 360-degree Virtual Reality Patient Tour
  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).
  arm group label: Intervention group - VR
  intervention type: Diagnostic Test
  intervention name: State Trait Anxiety Inventory
  description: Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.
  arm group label: Control group
  arm group label: Intervention group - VR
  other name: STAI
  intervention type: Diagnostic Test
  intervention name: Amsterdam Preoperative Anxiety and Information Scale
  description: This validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.
  arm group label: Control group
  arm group label: Intervention group - VR
  other name: APAIS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jolanda Kluin, MD, PhD
  role: Principal Investigator
  affiliation: j.kluin@amsterdamumc.nl
  last name: Sulayman el Mathari, MD
  phone: +31628156982
  email: s.elmathari@amsterdamumc.nl
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Jolanda Kluin
  investigator title: Professor of Cardiothoracic Surgery
  mesh term: Aortic Valve Disease
  mesh term: Heart Valve Diseases
  sharing ipd: Undecided
  ipd description: When asked for, a construction will be made to share data. At the end of the study.