<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/NCT03827304</url>
  </required_header>
  <id_info>
    <org_study_id>AA8434</org_study_id>
    <nct_id>NCT03827304</nct_id>
  </id_info>
  <brief_title>Using an Interactive Virtual Reality System to Distract Burns Patients During Burn Treatments</brief_title>
  <official_title>The Development of Interactive Virtual Reality System to Distract Burns Patients Away From Their Pain During Clinical Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Hallam University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Sheffield</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheffield Hallam University</source>
  <oversight_info>
    <has_dmc>No</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 aims and objectives of the clinical feasibility trial are:&#xD;
&#xD;
        -  to investigate the potential for VR to reduced perceived pain and anxiety during painful&#xD;
           dressings changes in a small sample of burns patients;&#xD;
&#xD;
        -  to measure the impact of the interventions on objective indicators of pain and distress&#xD;
           during dressing changes within the small sample&#xD;
&#xD;
        -  to assess pain medication use during virtual reality interventions&#xD;
&#xD;
        -  to compare the above effects and experiences across two conditions within each&#xD;
           participant: an active version of a virtual reality intervention, and a 'control'&#xD;
           condition of no intervention;&#xD;
&#xD;
        -  to assess the perceived usability, acceptability, engagement with and enjoyment of the&#xD;
           virtual reality intervention to the patients&#xD;
&#xD;
        -  to consider the apparent feasibility of the virtual reality intervention within a Burns&#xD;
           Unit inpatient setting during painful dressing changes 4. Design This is an exploratory&#xD;
           feasibility study with a small clinical sample of burns patients and staff caring for&#xD;
           them, in a single burns unit setting, employing mixed methods and a repeated measures&#xD;
           design to achieve the aims set out above.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The target sample for the clinical feasibility trial are adult burn patients (18+), who were&#xD;
      English-speakers, and therefore able to consent for themselves to participate in the&#xD;
      research. In order to avoid unnecessary psychological or physical distress, we excluded those&#xD;
      with active PTSD or psychotic symptoms, or high levels of distress as judged by Burns Unit&#xD;
      clinicians, where the use of VR might be contraindicated. People with mild-moderate or well&#xD;
      controlled mental health problems were not be excluded from the study. In addition, those&#xD;
      with head and neck burns were excluded as they were unable to wear the VR equipment during&#xD;
      dressing changes. The participants were in-patients receiving regular dressing changes during&#xD;
      the study period.&#xD;
&#xD;
      Materials used included the VR headset and the software developed using gaming environments,&#xD;
      a booklet of questionnaires for the participants to complete, a monitor to measure heart&#xD;
      rate, a brief interview schedule, a focus group schedule and digital recording equipment. An&#xD;
      active (participatory) gaming environment was developed for participants to trial On three&#xD;
      dressing change days participants were asked to complete the two 0-100 ratings 4 times -&#xD;
      before their dressing change and three afterwards: immediately after the dressing change and&#xD;
      then after 2 and 4 hours. They were also asked to complete the scales once on a non-dressing&#xD;
      day after the study, to allow assessment of the impact beyond dressing days of the VR&#xD;
      intervention. The researcher added in the dates and times for each participant in their&#xD;
      booklet. These outcomes were selected as especially important to the study, but also to&#xD;
      minimise participant burden. The booklet contained boxes and prompts for participants to add&#xD;
      free text responses about the experiences we being monitoring, should they wish.&#xD;
&#xD;
      Patients were not asked during dressing changes to make any comment about their experience,&#xD;
      so that they could concentrate on the VR environments and to avoid adding to patient burden&#xD;
      on the non-intervention condition.&#xD;
&#xD;
      After each VR intervention dressing change, patients were asked a few questions about their&#xD;
      experience of pain and the gaming environment, such as 'How was your pain during the dressing&#xD;
      change while you were in the VR environment?' 'How did you feel generally during the&#xD;
      experience?' 'How helpful did you find the VR during the dressing change?' etc. These short&#xD;
      interviews (max 10 minutes) were recorded on a password protected digital recorder.&#xD;
&#xD;
      After both interventions, on a non-dressing change day, another short interview (max 10&#xD;
      minutes) was conducted to enable the participant to make comparisons between the different VR&#xD;
      experiences and general comments about their effectiveness, usability and impact compared&#xD;
      with no VR. Questions included 'Which VR experience did you prefer and why?' 'From your&#xD;
      experience how does a dressing change under VR compare with one with no VR experience?' etc.&#xD;
&#xD;
      Nursing staff were interviewed in a focus group at the end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>
    <intervention_model_description>This study aimed to explore:&#xD;
patient and staff perceptions of the effect of active and passive VR on perceived pain and anxiety during painful dressings changes;&#xD;
patient perceptions of the usability, acceptability, engagement with and enjoyment of active and passive VR scenarios;&#xD;
staff perceptions about the usability and implications of the VR technology within a Burns Unit inpatient setting.&#xD;
Methods: This was a small-scale qualitative usability study, employing qualitative methods to intervention development and feasibility work.&#xD;
Patients: Participants were adult inpatients at the local Burns Unit who were undergoing regular dressing changes during the study period. Exclusion criteria included head and neck burns, wound infection, current diagnosis of PTSD, active psychotic symptoms or high levels of distress. Suitable patients were briefly introduced to the study and supplied with a full information sheet, with details about aims, procedures and rights.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perceptions, usability and effectiveness of VR environments in painful dressing changes</measure>
    <time_frame>Two weeks</time_frame>
    <description>Qualitative description of patient experience; pain scores</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Burns</condition>
  <arm_group>
    <arm_group_label>Burns dressings patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual Reality pain distraction games scenarios</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality Distraction from Burn Pain</intervention_name>
    <description>Patients wore a VR headset while undergoing a burns dressing change</description>
    <arm_group_label>Burns dressings patients</arm_group_label>
    <other_name>Burns Dressings Patients</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult burns in-patients&#xD;
&#xD;
          -  receiving regular dressing changes during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active PTSD or psychotic symptoms&#xD;
&#xD;
          -  high levels of distress&#xD;
&#xD;
          -  head and neck burns&#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>Ivan Phelan, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheffield Hallam University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ivan Phelan</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S1 2NU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Burns</keyword>
  <keyword>Virtual Reality</keyword>
  <keyword>Qualitative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 17, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03827304
org study id: AA8434
nct id: NCT03827304
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aims and objectives of the clinical feasibility trial are:

        -  to investigate the potential for VR to reduced perceived pain and anxiety during painful
           dressings changes in a small sample of burns patients;

        -  to measure the impact of the interventions on objective indicators of pain and distress
           during dressing changes within the small sample

        -  to assess pain medication use during virtual reality interventions

        -  to compare the above effects and experiences across two conditions within each
           participant: an active version of a virtual reality intervention, and a 'control'
           condition of no intervention;

        -  to assess the perceived usability, acceptability, engagement with and enjoyment of the
           virtual reality intervention to the patients

        -  to consider the apparent feasibility of the virtual reality intervention within a Burns
           Unit inpatient setting during painful dressing changes 4. Design This is an exploratory
           feasibility study with a small clinical sample of burns patients and staff caring for
           them, in a single burns unit setting, employing mixed methods and a repeated measures
           design to achieve the aims set out above.
The target sample for the clinical feasibility trial are adult burn patients (18+), who were
      English-speakers, and therefore able to consent for themselves to participate in the
      research. In order to avoid unnecessary psychological or physical distress, we excluded those
      with active PTSD or psychotic symptoms, or high levels of distress as judged by Burns Unit
      clinicians, where the use of VR might be contraindicated. People with mild-moderate or well
      controlled mental health problems were not be excluded from the study. In addition, those
      with head and neck burns were excluded as they were unable to wear the VR equipment during
      dressing changes. The participants were in-patients receiving regular dressing changes during
      the study period.

      Materials used included the VR headset and the software developed using gaming environments,
      a booklet of questionnaires for the participants to complete, a monitor to measure heart
      rate, a brief interview schedule, a focus group schedule and digital recording equipment. An
      active (participatory) gaming environment was developed for participants to trial On three
      dressing change days participants were asked to complete the two 0-100 ratings 4 times -
      before their dressing change and three afterwards: immediately after the dressing change and
      then after 2 and 4 hours. They were also asked to complete the scales once on a non-dressing
      day after the study, to allow assessment of the impact beyond dressing days of the VR
      intervention. The researcher added in the dates and times for each participant in their
      booklet. These outcomes were selected as especially important to the study, but also to
      minimise participant burden. The booklet contained boxes and prompts for participants to add
      free text responses about the experiences we being monitoring, should they wish.

      Patients were not asked during dressing changes to make any comment about their experience,
      so that they could concentrate on the VR environments and to avoid adding to patient burden
      on the non-intervention condition.

      After each VR intervention dressing change, patients were asked a few questions about their
      experience of pain and the gaming environment, such as 'How was your pain during the dressing
      change while you were in the VR environment?' 'How did you feel generally during the
      experience?' 'How helpful did you find the VR during the dressing change?' etc. These short
      interviews (max 10 minutes) were recorded on a password protected digital recorder.

      After both interventions, on a non-dressing change day, another short interview (max 10
      minutes) was conducted to enable the participant to make comparisons between the different VR
      experiences and general comments about their effectiveness, usability and impact compared
      with no VR. Questions included 'Which VR experience did you prefer and why?' 'From your
      experience how does a dressing change under VR compare with one with no VR experience?' etc.

      Nursing staff were interviewed in a focus group at the end of the study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study aimed to explore:
patient and staff perceptions of the effect of active and passive VR on perceived pain and anxiety during painful dressings changes;
patient perceptions of the usability, acceptability, engagement with and enjoyment of active and passive VR scenarios;
staff perceptions about the usability and implications of the VR technology within a Burns Unit inpatient setting.
Methods: This was a small-scale qualitative usability study, employing qualitative methods to intervention development and feasibility work.
Patients: Participants were adult inpatients at the local Burns Unit who were undergoing regular dressing changes during the study period. Exclusion criteria included head and neck burns, wound infection, current diagnosis of PTSD, active psychotic symptoms or high levels of distress. Suitable patients were briefly introduced to the study and supplied with a full information sheet, with details about aims, procedures and rights.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Perceptions, usability and effectiveness of VR environments in painful dressing changes
time frame: Two weeks
description: Qualitative description of patient experience; pain scores
arm group label: Burns dressings patients
arm group type: Experimental
description: Virtual Reality pain distraction games scenarios
intervention type: Device
intervention name: Virtual Reality Distraction from Burn Pain
description: Patients wore a VR headset while undergoing a burns dressing change
arm group label: Burns dressings patients
other name: Burns Dressings Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ivan Phelan, MSc
role: Principal Investigator
affiliation: Sheffield Hallam University
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Burns
sharing ipd: No
submitted: April 17, 2023