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/NCT06001502</url>
    </required_header>
    <id_info>
      <org_study_id>NL79616.018.21</org_study_id>
      <nct_id>NCT06001502</nct_id>
    </id_info>
    <brief_title>The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.</brief_title>
    <acronym>VRECOVERY</acronym>
    <official_title>The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.</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>
        The objective of this study is to investigate the effect of VR on post-operative pain and&#xD;
        anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting&#xD;
        (CABG) procedure.&#xD;
  &#xD;
        Participants in the intervention group will receive a 20 minute session with the head mounted&#xD;
        VR device on post-operative days 1,2 and 3.&#xD;
  &#xD;
        Participants in the control group will be treated with conventional post-operative care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: The objective of this study is to investigate the effect of VR on post-operative&#xD;
        pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass&#xD;
        grafting (CABG) procedure.&#xD;
  &#xD;
        Study design: This study is a single-center randomized control trial.&#xD;
  &#xD;
        Study population: Patients who have undergone a CABG procedure (n=100).&#xD;
  &#xD;
        Intervention: The intervention group (n=50) will use the VR distraction therapy device at day&#xD;
        1, 2 and 3 after surgery on the general ward. The control group (n=50) will be treated with&#xD;
        conventional post-operative pain and anxiety management.&#xD;
  &#xD;
        Main study parameters/endpoints: The main study parameters at day 1, 2 and 3 after surgery.&#xD;
        These are the Numeric Rating Scale (NRS) to assess the effect of pain on mobility, the&#xD;
        Quality of Recovery-15 questionnaire, the State-Trait Anxiety Inventory-6 questionnaire and&#xD;
        assessment of analgesic use. At follow-up, participants will be called to gather one-time&#xD;
        QoR-15 and STAI-6 questionnaire data 6 weeks after the surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Numeric Rating Scale (NRS)</measure>
      <time_frame>Post-operative days 1,2 and 3 directly after the VR intervention</time_frame>
      <description>The NRS score is a numeric scale in which individuals rate pain from 0 (no pain) tot 10 (worst pain). This is a subjective score which is assessed verbally and used frequently in standard clinical care in multiple medical specialties.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>State- Trait Anxiety Inventory 6 questionnaire</measure>
      <time_frame>Post-operative days 1,2 and 3 directly after the VR intervention</time_frame>
      <description>The STAI-6 questionnaire is a validated psychological inventory designed to measure worry, tension and anxiety in an individual. It is a shortend version of the STAI score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of Recovery-15</measure>
      <time_frame>Post-operative days 1,2 and 3 directly after the VR intervention</time_frame>
      <description>The QoR-15 questionnaire is a clinical validated instrument to measure post-operative quality of recovery.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Post Operative Pain</condition>
    <condition>Post Operative Anxiety</condition>
    <condition>Heart Surgery</condition>
    <condition>Coronary Artery Bypass Grafting</condition>
    <condition>Virtual Reality</condition>
    <arm_group>
      <arm_group_label>Virtual Reality group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Virtual Reality distraction therapy on post-operative days 1,2 and 3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Conventional post-operative pain and anxiety management</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Virtual Reality distraction therapy</intervention_name>
      <description>The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings</description>
      <arm_group_label>Virtual Reality group</arm_group_label>
      <other_name>Healthy Mind VR device</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years or older with written informed consent&#xD;
  &#xD;
            -  Patients undergoing surgical CABG&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Major comorbidities besides coronary artery disease&#xD;
  &#xD;
            -  Complicated surgical procedure&#xD;
  &#xD;
            -  Hearing and/or visual impairments&#xD;
  &#xD;
            -  Psychiatric impairments&#xD;
  &#xD;
            -  Complaints of vomiting and nausea&#xD;
  &#xD;
            -  History of epilepsy&#xD;
  &#xD;
            -  Claustrophobia&#xD;
  &#xD;
            -  Facial wounds and skin defects at site of application&#xD;
  &#xD;
            -  Patients placed in clinical isolation&#xD;
  &#xD;
            -  Readmission to the intensive care unit&#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>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sulayman El Mathari, MD</last_name>
      <phone>+31205668188</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>
    </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 dr. J. Kluin, MD, PhD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Upon request available.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>After publication</ipd_time_frame>
      <ipd_access_criteria>Upon request available.</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>June 1, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT06001502/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06001502
  org study id: NL79616.018.21
  nct id: NCT06001502
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to investigate the effect of VR on post-operative pain and
        anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting
        (CABG) procedure.
  
        Participants in the intervention group will receive a 20 minute session with the head mounted
        VR device on post-operative days 1,2 and 3.
  
        Participants in the control group will be treated with conventional post-operative care.
  Objective: The objective of this study is to investigate the effect of VR on post-operative
        pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass
        grafting (CABG) procedure.
  
        Study design: This study is a single-center randomized control trial.
  
        Study population: Patients who have undergone a CABG procedure (n=100).
  
        Intervention: The intervention group (n=50) will use the VR distraction therapy device at day
        1, 2 and 3 after surgery on the general ward. The control group (n=50) will be treated with
        conventional post-operative pain and anxiety management.
  
        Main study parameters/endpoints: The main study parameters at day 1, 2 and 3 after surgery.
        These are the Numeric Rating Scale (NRS) to assess the effect of pain on mobility, the
        Quality of Recovery-15 questionnaire, the State-Trait Anxiety Inventory-6 questionnaire and
        assessment of analgesic use. At follow-up, participants will be called to gather one-time
        QoR-15 and STAI-6 questionnaire data 6 weeks after the surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Numeric Rating Scale (NRS)
  time frame: Post-operative days 1,2 and 3 directly after the VR intervention
  description: The NRS score is a numeric scale in which individuals rate pain from 0 (no pain) tot 10 (worst pain). This is a subjective score which is assessed verbally and used frequently in standard clinical care in multiple medical specialties.
  measure: State- Trait Anxiety Inventory 6 questionnaire
  time frame: Post-operative days 1,2 and 3 directly after the VR intervention
  description: The STAI-6 questionnaire is a validated psychological inventory designed to measure worry, tension and anxiety in an individual. It is a shortend version of the STAI score
  measure: Quality of Recovery-15
  time frame: Post-operative days 1,2 and 3 directly after the VR intervention
  description: The QoR-15 questionnaire is a clinical validated instrument to measure post-operative quality of recovery.
  arm group label: Virtual Reality group
  arm group type: Experimental
  description: Virtual Reality distraction therapy on post-operative days 1,2 and 3.
  arm group label: Control Group
  arm group type: No Intervention
  description: Conventional post-operative pain and anxiety management
  intervention type: Device
  intervention name: Virtual Reality distraction therapy
  description: The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings
  arm group label: Virtual Reality group
  other name: Healthy Mind VR device
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jolanda Kluin, MD, PhD
  role: Principal Investigator
  affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  last name: Sulayman El Mathari, MD
  phone: +31205668188
  email: s.elmathari@amsterdamumc.nl
  facility: 
  status: Recruiting
  contact: 
  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 dr. J. Kluin, MD, PhD
  mesh term: Pain, Postoperative
  mesh term: Anxiety Disorders
  sharing ipd: Yes
  ipd description: Upon request available.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: After publication
  ipd access criteria: Upon request available.
  provided document: 