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/NCT06039462</url>
    </required_header>
    <id_info>
      <org_study_id>PA21/140676</org_study_id>
      <nct_id>NCT06039462</nct_id>
    </id_info>
    <brief_title>Virtual Reality Distraction Therapy in Paediatrics</brief_title>
    <official_title>Improve Patient Safety and Wellbeing in Leeds Children Hospital for Patients Undergoing Procedures Through Use of Virtual Reality Distraction Therapy (VRDT), and Improve Their Overall Experience.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Leeds Teaching Hospitals NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Leeds Teaching Hospitals NHS Trust</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        For many children in hospital, having blood tests or cannulation is a significantly&#xD;
        distressing event physically, psychologically and emotionally. Use of distraction during&#xD;
        invasive procedures is already common practice in paediatrics to improve the experience both&#xD;
        for the child and parents. Use of Virtual Reality (VR) and VR Distraction Therapy (VRDT) is a&#xD;
        relatively new concept, but has already shown promising results in studies.&#xD;
  &#xD;
        &quot;VR offers an interactive distraction technique, a contrast to the passive distraction of&#xD;
        reading a book or playing games on a tablet … and [VR] is thought to alter pain perception&#xD;
        and the child's interpretation of pain signals.&quot; (Cochrane Library - Virtual reality&#xD;
        simulation for reducing pain in children).&#xD;
  &#xD;
        The project aims to collect data about venepuncture, cannulation, long lines - qualitative&#xD;
        and quantitative data - from children and parents. This studyl compares current standard&#xD;
        practice with VR distraction therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Not all studies raise significant issues. Some studies may have straightforward ethical or&#xD;
        other issues that can be identified and managed routinely. Others may present significant&#xD;
        issues requiring further consideration by a REC, HRA, or other review body (as appropriate to&#xD;
        the issue). Studies that present a minimal risk to participants may raise complex&#xD;
        organisational or legal issues. You should try to consider all the types of issues that the&#xD;
        different reviewers may need to consider.&#xD;
  &#xD;
        VR companies do not recommend use of their headsets in children under 13 years of age. I do&#xD;
        not anticipate including 8-12 year olds in the study causing any issues based on experience&#xD;
        and advice from relevant experts (see below). In summary, the age cut off is borne of lack of&#xD;
        evidence for long-term effects of VR on visual or brain development, rather than specific&#xD;
        concerns or evidence existing to inform the age cut off.&#xD;
  &#xD;
        Children's Hospital Colorado (US) use VR in children of 6 years and above. Speaking with&#xD;
        their Associate Professor of Paediatrics, the age limitation is not derived from medical&#xD;
        standards or concerns. They discussed with their Neurology department who agreed there is no&#xD;
        age-specific concern that warrants the 12 year cut-off, and they also rely upon the&#xD;
        professional expertise of Child Life Specialists who routinely screen toys and devices for&#xD;
        age-appropriate application. They have used VR in healthcare for children several hundred&#xD;
        times and have no concerns about the age cut off the VR companies suggest.&#xD;
  &#xD;
        Stanford University School of Medicine (US) run the highest volume clinical VR therapy&#xD;
        program in the US, with thousands of children each year receiving VR. Their department&#xD;
        similarly does not exclude under 13 year olds from their program.&#xD;
  &#xD;
        Clinicians experienced with VR in the UK have spoken to VR companies involved in their&#xD;
        studies, and the information gives was that there no long-term data on VR and its effects on&#xD;
        brain and visual development. These clinicians also use VR on children aged 5-6 years and&#xD;
        above.&#xD;
  &#xD;
        I have met with the VR company Dubit Limited, which shows in its global trends data that&#xD;
        children much younger than 13 are already using VR. The publication &quot;Children and Virtual&#xD;
        Reality: Emerging Possibilities and Challenges&quot; contains data from studies looking at the&#xD;
        8-12 year old age group; there is not any current evidence of adverse events in this age&#xD;
        group, though transient change to visual function has been seen only in a minority of VR&#xD;
        users in this age group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 23, 2021</start_date>
    <completion_date type="Actual">December 13, 2021</completion_date>
    <primary_completion_date type="Actual">December 13, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reduction in fear and anxiety associated with treatment.</measure>
      <time_frame>24 hours</time_frame>
      <description>Questionnaire (x1) completed at the time of intervention</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">108</enrollment>
    <condition>Child Behavior</condition>
    <arm_group>
      <arm_group_label>Children undergoing surgery</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Application of a virtual reality headset</intervention_name>
      <description>Use of a headset to experience a different reality</description>
      <arm_group_label>Children undergoing surgery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Paediatric patient, aged 8-12 years or 13-18 years.&#xD;
  &#xD;
            2. Under care of paediatric department - as inpatient&#xD;
  &#xD;
            3. Requiring invasive procedure - including (but not limited to) blood sampling&#xD;
               (venepuncture), siting intravenous access (cannulation, long line, Port-a-cath&#xD;
               access), lumbar puncture, other device insertion or removal (e.g. catheter, drain,&#xD;
               cardiac pacing wires, intra-thecal baclofen pump refills), minor surgical bedside&#xD;
               procedures.&#xD;
  &#xD;
            4. Consents to study - either child with mental capacity, or parent/legal guardian on&#xD;
               behalf of their child.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants will not be recruited if they or their parent/guardian believe the child&#xD;
               will not engage or cannot engage with procedural distraction.&#xD;
  &#xD;
          Participants will not be recruited to the VR group if he/she meets any of the following&#xD;
          exclusion criteria:&#xD;
  &#xD;
            -  Patients not under care of paediatrics (over 18 years of age)&#xD;
  &#xD;
            -  If the child has previously been recruited to the study - each child may only be in&#xD;
               the study once&#xD;
  &#xD;
            -  Contraindications to use of VR or the VR headset&#xD;
  &#xD;
                 -  Inability to wear headset - facial or skull injury/fracture&#xD;
  &#xD;
                 -  Marked reduced visual acuity or blindness&#xD;
  &#xD;
                 -  Interference with care - e.g. requirement of other medical equipment that cannot&#xD;
                    be worn/administered simultaneously with VR e.g. non-invasive ventilation.&#xD;
  &#xD;
                 -  Pre-procedure dizziness, nausea, vertigo&#xD;
  &#xD;
                 -  History of photosensitive epilepsy&#xD;
  &#xD;
                 -  Potential for poor cooperation with procedure (hence risk of moving) - this is&#xD;
                    more likely in the age range 8-12 years old. Prior discussion to be held with&#xD;
                    parents through PIL and consent form to judge if the child is likely to be&#xD;
                    cooperative.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Leeds Teaching Hopsital NHS Trust</name>
        <address>
          <city>Leeds</city>
          <zip>LS9 7TF</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06039462
  org study id: PA21/140676
  nct id: NCT06039462
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  For many children in hospital, having blood tests or cannulation is a significantly
        distressing event physically, psychologically and emotionally. Use of distraction during
        invasive procedures is already common practice in paediatrics to improve the experience both
        for the child and parents. Use of Virtual Reality (VR) and VR Distraction Therapy (VRDT) is a
        relatively new concept, but has already shown promising results in studies.
  
        "VR offers an interactive distraction technique, a contrast to the passive distraction of
        reading a book or playing games on a tablet … and [VR] is thought to alter pain perception
        and the child's interpretation of pain signals." (Cochrane Library - Virtual reality
        simulation for reducing pain in children).
  
        The project aims to collect data about venepuncture, cannulation, long lines - qualitative
        and quantitative data - from children and parents. This studyl compares current standard
        practice with VR distraction therapy.
  Not all studies raise significant issues. Some studies may have straightforward ethical or
        other issues that can be identified and managed routinely. Others may present significant
        issues requiring further consideration by a REC, HRA, or other review body (as appropriate to
        the issue). Studies that present a minimal risk to participants may raise complex
        organisational or legal issues. You should try to consider all the types of issues that the
        different reviewers may need to consider.
  
        VR companies do not recommend use of their headsets in children under 13 years of age. I do
        not anticipate including 8-12 year olds in the study causing any issues based on experience
        and advice from relevant experts (see below). In summary, the age cut off is borne of lack of
        evidence for long-term effects of VR on visual or brain development, rather than specific
        concerns or evidence existing to inform the age cut off.
  
        Children's Hospital Colorado (US) use VR in children of 6 years and above. Speaking with
        their Associate Professor of Paediatrics, the age limitation is not derived from medical
        standards or concerns. They discussed with their Neurology department who agreed there is no
        age-specific concern that warrants the 12 year cut-off, and they also rely upon the
        professional expertise of Child Life Specialists who routinely screen toys and devices for
        age-appropriate application. They have used VR in healthcare for children several hundred
        times and have no concerns about the age cut off the VR companies suggest.
  
        Stanford University School of Medicine (US) run the highest volume clinical VR therapy
        program in the US, with thousands of children each year receiving VR. Their department
        similarly does not exclude under 13 year olds from their program.
  
        Clinicians experienced with VR in the UK have spoken to VR companies involved in their
        studies, and the information gives was that there no long-term data on VR and its effects on
        brain and visual development. These clinicians also use VR on children aged 5-6 years and
        above.
  
        I have met with the VR company Dubit Limited, which shows in its global trends data that
        children much younger than 13 are already using VR. The publication "Children and Virtual
        Reality: Emerging Possibilities and Challenges" contains data from studies looking at the
        8-12 year old age group; there is not any current evidence of adverse events in this age
        group, though transient change to visual function has been seen only in a minority of VR
        users in this age group.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Reduction in fear and anxiety associated with treatment.
  time frame: 24 hours
  description: Questionnaire (x1) completed at the time of intervention
  arm group label: Children undergoing surgery
  arm group type: Other
  intervention type: Behavioral
  intervention name: Application of a virtual reality headset
  description: Use of a headset to experience a different reality
  arm group label: Children undergoing surgery
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 18 Years
  healthy volunteers: No
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  sharing ipd: No