<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/NCT02977923</url>
  </required_header>
  <id_info>
    <org_study_id>1383</org_study_id>
    <nct_id>NCT02977923</nct_id>
  </id_info>
  <brief_title>Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: a Pilot Study</brief_title>
  <acronym>DREAM-P</acronym>
  <official_title>Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Justine's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quebec Nursing Intervention Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Justine's Hospital</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>
      Children with injuries, including burns, experience severe pain intensity during medical&#xD;
      procedures despite the increasing doses of analgesics. Current guidelines on pediatric&#xD;
      procedural pain management recommend the combination of non-pharmacological and&#xD;
      pharmacological interventions to enhance pain management and decrease the numerous side&#xD;
      effects of analgesics. Virtual reality (VR) has gained growing consideration as a&#xD;
      non-pharmacological method as it engages multiple senses and allows interactions with a&#xD;
      virtual world. Oculus Rift ® (OR) is a new technology in VR that provides more immersiveness,&#xD;
      at a relatively low cost, and could probably improve the management of pain and anxiety in&#xD;
      wound care.&#xD;
&#xD;
      Overall hypothesis: Distraction by VR via the OR, in combination with the standard&#xD;
      pharmacological treatment, is a feasible, acceptable and satisfactory method for the&#xD;
      management of pain and anxiety during wound-related treatments in children with injuries.&#xD;
&#xD;
      Note that this pilot study will precede a larger trial aimed at assessing the effect of&#xD;
      virtual reality distraction via the Oculus Rift ® (DREAM-T: NCT02947243)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND:&#xD;
&#xD;
      Injuries, including burns, are the leading cause of morbidity and mortality in children. They&#xD;
      are associated with a lot of pain that is difficult to treat and can impede recovery, cause&#xD;
      high levels of anxiety and alter future pain behaviors, resulting, at times, in chronic pain,&#xD;
      paresthesia, or depression. Pain can also decrease participation in treatments such as&#xD;
      physiotherapy resulting in poor health outcomes. Beyond the immediate pain experience,&#xD;
      children may also develop pain memory circuits. Procedural pain is still largely managed&#xD;
      pharmacologically mostly through the use of opioids, benzodiazepines, and other&#xD;
      pharmacological agents which cause a lot of side effects and do not always provide sufficient&#xD;
      pain reduction. In recent years, the effectiveness of multimodal approaches combining&#xD;
      medication with non-pharmacological interventions for procedural pain relief has been&#xD;
      highlighte. Distraction techniques engaging multiple senses may grab the child's attention&#xD;
      more than the techniques that only engage one sense (e.g, music), hence, the increasing&#xD;
      interest in more immersive and interactive methods of distraction such as Virtual Reality&#xD;
      (VR).&#xD;
&#xD;
      VR is an active distraction method that allows the user to interact with an immersive&#xD;
      environment generated by a computer stimulating different senses. A review of studies on VR,&#xD;
      mostly conducted with adult burn patients, showed a 35 to 50% reduction in procedural pain&#xD;
      while using VR. However, despite promising results, the use of VR in healthcare settings has&#xD;
      been limited, mainly due to its high cost. Reviews have highlighted the need for more&#xD;
      research but mostly for the development of more portable, less expensive and more developed&#xD;
      VR systems that would promote pain reduction during burn procedures especially for children&#xD;
      with burn injuries who are considered one of the most challenging burn populations. However,&#xD;
      there has been a breakthrough in technology since 2014 when big scale companies started&#xD;
      investing in VR development for commercial gaming. Facebook purchased the Oculus Rift (OR)&#xD;
      for mass production allowing access to the latest technology in VR at a relatively low cost.&#xD;
      OR is a VR tool that provides a wide field of view (FOV), high-resolution display, integrated&#xD;
      3D audio and motion detection. In addition, it's highly immersive properties could help&#xD;
      achieve more analgesia compared to other VR techniques as a review has shown that the sense&#xD;
      of presence influences the effectiveness of VR-based analgesia. The sense of presence is a&#xD;
      subjective psychological state of consciousness of being in the virtual world whereas&#xD;
      immersiveness refers to the physical environment that could be quantified by measuring the&#xD;
      field of view or the peripheral vision in the VR goggles. The availability of inexpensive yet&#xD;
      highly immersive VR goggles such as OR could increase the use of VR in pain management and&#xD;
      burn settings while significantly improving its cost-effectiveness. A single case study&#xD;
      assessed the feasibility of a VR intervention via OR in one child of 11 years old with burn&#xD;
      injuries during occupational therapy. The study showed a reduction in pain intensity and pain&#xD;
      unpleasantness experienced by the patient, without any side effects. To our knowledge, no&#xD;
      other studies have tested the feasibility of OR for procedural pain management in children&#xD;
      with injuries undergoing painful physiotherapy treatments or wound care.&#xD;
&#xD;
      AIM: The aim of this pilot clinical trial is to assess the acceptability and feasibility of&#xD;
      VR distraction using the OR in children with injuries undergoing wound-related treatments&#xD;
      (physiotherapy or dressing change). We also plan to evaluate the feasibility of the design&#xD;
      and to predict appropriate sample size for a larger-scale clinical trial.&#xD;
&#xD;
      METHODS:&#xD;
&#xD;
      Design: Within-subject/crossover study design. Each child will serve as his own control and&#xD;
      will receive both standard and experimental treatment during the same treatment session&#xD;
      through a randomized order.&#xD;
&#xD;
      Sample and Setting: Convenience sampling on the surgical-trauma unit at CHU Ste-Justine, of&#xD;
      children presenting with an injury.&#xD;
&#xD;
      Interventions. A) Standard pharmacological treatment as per the unit's protocol. B) VR&#xD;
      distraction through the use of OR.The video games were developed by our team with a&#xD;
      personalized care content tailored to the children's developmental stage and to maximize the&#xD;
      feeling of immersion and minimize cybersickness, and approved by a team of healthcare&#xD;
      professionals in pediatric care.&#xD;
&#xD;
      Study proceedings: Physiotherapy sessions and dressing changes typically last between 20 to&#xD;
      30 minutes. The duration will be divided into two sequences of the same duration (10 to 15&#xD;
      minutes) where the participant receives the same care by the same healthcare professional.&#xD;
      For one sequence, only the standard treatment will be administered and for the other&#xD;
      sequence, patients will receive the standard treatment in addition to VR via OR in a&#xD;
      randomized order.&#xD;
&#xD;
      Measures: Pain and anxiety measures will be taken before the treatment session at (T1), after&#xD;
      the first sequence of the session (T2) and after the second sequence of the session (T3)&#xD;
      followed by a measure of nurses' satisfaction level via a questionnaire developed and&#xD;
      pretested by the team. We will collect data on the average doses of analgesics administered&#xD;
      before and during the session, and the side effects experienced in addition to the design's&#xD;
      feasibility outcomes: participants recruited each month, adherence to study protocol.&#xD;
&#xD;
      Data analysis: Quantitative analysis. Mean differences in pain scores between sequences will&#xD;
      be compared using Wilcoxon test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability</measure>
    <time_frame>T4, immediately after the procedure completion, before leaving the procedure room</time_frame>
    <description>To assess the acceptability including the satisfaction of healthcare professionals regarding the use of the VR distraction via Oculus Rift during the treatment session. Pre-tested tailored questionnaire including satisfaction and acceptability outcomes (tolerance, positive and negative aspects, secondary effects).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Pain Score</measure>
    <time_frame>T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session</time_frame>
    <description>Numerical Rating Scale (NRS) ranging from 0 to 10; 0=no pain to 10=pain as bad as it could be</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Experience</measure>
    <time_frame>T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)</time_frame>
    <description>Graphic Rating Scale (GRS) consisting of seven items to measure the cognitive, the affective and the sensory components of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expected Anxiety</measure>
    <time_frame>Baseline (T1)</time_frame>
    <description>Children's Fear Scale (CFS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experienced Anxiety</measure>
    <time_frame>T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)</time_frame>
    <description>Children's Fear Scale (CFS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort Level</measure>
    <time_frame>T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)</time_frame>
    <description>Behavioural observation scale of comfort level for child burn victims (OCCEB-BECCO)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Memory</measure>
    <time_frame>24 hours after the procedure (T5)</time_frame>
    <description>A measure of the child's memory of pain using the same measure (NRS) administered during the initial data collection to assess this construct</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Memory</measure>
    <time_frame>24 hours after the procedure (T5)</time_frame>
    <description>A measure of the child's memory of anxiety using the same measure (CFS) administered during the initial data collection to assess this construct</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range Of Motion</measure>
    <time_frame>Baseline (T1); T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)</time_frame>
    <description>(only for physiotherapy sessions) Using a goniometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Pain</condition>
  <condition>Anxiety</condition>
  <condition>Burns</condition>
  <condition>Child</condition>
  <condition>Injuries</condition>
  <arm_group>
    <arm_group_label>Standard pharmacological treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>According to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and pain clinic nurse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VR distraction via Oculus Rift</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to standard pharmacological treatment, Virtual reality distraction through the use of Oculus Rift® will be used as the experimental intervention. The Oculus Rift (Consumer version) is made of two Oled panels with a resolution of 1200p running at 90Hz. It has very effective 360 degree positional tracking and integrated 3D audio. These combine to produce a high level of immersion, with high photorealism while maintaining the low latency necessary to induce presence and prevent cybersickness. The child, depending on the site of the injury, will have the opportunity to interact with the game. Video games, approved by healthcare professionals with extensive experience in pediatrics, were adapted for children and tailored to minimize cyber sickness.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VR distraction via Oculus Rift</intervention_name>
    <description>In addition to standard pharmacological treatment, Virtual reality distraction through the use of Oculus Rift® will be used as the experimental intervention. The Oculus Rift (Consumer version) is made of two Oled panels with a resolution of 1200p running at 90Hz. It has very effective 360 degree positional tracking and integrated 3D audio. These combine to produce a high level of immersion, with high photorealism while maintaining the low latency necessary to induce presence and prevent cybersickness. The child, depending on the site of the injury, will have the opportunity to interact with the game. Video games, approved by healthcare professionals with extensive experience in pediatrics, were adapted for children and tailored to minimize cyber sickness.</description>
    <arm_group_label>VR distraction via Oculus Rift</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard pharmacological treatment</intervention_name>
    <description>according to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and pain clinic nurse.</description>
    <arm_group_label>Standard pharmacological treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  suffer from a burn or another injury requiring wound dressing change or physiotherapy&#xD;
&#xD;
          -  presence of a consenting parent who can understand, read and write either French or&#xD;
             English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requiring intensive care&#xD;
&#xD;
          -  Having a diagnosed cognitive impairment&#xD;
&#xD;
          -  Are unconscious or intubated during dressing change or physiotherapy sessions&#xD;
&#xD;
          -  Suffering from epilepsy (considering the nature of the intervention)&#xD;
&#xD;
          -  Allergic to opioids or other analgesics used for standard pharmacological treatment&#xD;
&#xD;
          -  Having injuries on the face preventing the use of the Oculus Rift helmet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sylvie Le May, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Justine's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Ste. Justine</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 26, 2016</study_first_submitted>
  <study_first_submitted_qc>November 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>September 19, 2018</last_update_submitted>
  <last_update_submitted_qc>September 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Justine's Hospital</investigator_affiliation>
    <investigator_full_name>Sylvie Le May</investigator_full_name>
    <investigator_title>RN, PhD</investigator_title>
  </responsible_party>
  <keyword>Virtual reality</keyword>
  <keyword>Immersive distraction</keyword>
  <keyword>Oculus rift</keyword>
  <keyword>Virtual world</keyword>
  <keyword>Virtual environment</keyword>
  <keyword>Procedural pain</keyword>
  <keyword>Procedural anxiety</keyword>
  <keyword>Acute pain</keyword>
  <keyword>Pain management</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Children, Child</keyword>
  <keyword>Kid, Kids</keyword>
  <keyword>Pediatric, Pediatrics</keyword>
  <keyword>Young children</keyword>
  <keyword>Burns</keyword>
  <keyword>Burn injuries</keyword>
  <keyword>Burn unit</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Physical therapy</keyword>
  <keyword>Burn dressing</keyword>
  <keyword>Dressing change</keyword>
  <keyword>Non-pharmacological, nonpharmacological</keyword>
  <keyword>Clinical Research</keyword>
  <keyword>Nursing Practice</keyword>
  <keyword>Trauma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02977923
org study id: 1383
nct id: NCT02977923
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Children with injuries, including burns, experience severe pain intensity during medical
      procedures despite the increasing doses of analgesics. Current guidelines on pediatric
      procedural pain management recommend the combination of non-pharmacological and
      pharmacological interventions to enhance pain management and decrease the numerous side
      effects of analgesics. Virtual reality (VR) has gained growing consideration as a
      non-pharmacological method as it engages multiple senses and allows interactions with a
      virtual world. Oculus Rift ® (OR) is a new technology in VR that provides more immersiveness,
      at a relatively low cost, and could probably improve the management of pain and anxiety in
      wound care.

      Overall hypothesis: Distraction by VR via the OR, in combination with the standard
      pharmacological treatment, is a feasible, acceptable and satisfactory method for the
      management of pain and anxiety during wound-related treatments in children with injuries.

      Note that this pilot study will precede a larger trial aimed at assessing the effect of
      virtual reality distraction via the Oculus Rift ® (DREAM-T: NCT02947243)
BACKGROUND:

      Injuries, including burns, are the leading cause of morbidity and mortality in children. They
      are associated with a lot of pain that is difficult to treat and can impede recovery, cause
      high levels of anxiety and alter future pain behaviors, resulting, at times, in chronic pain,
      paresthesia, or depression. Pain can also decrease participation in treatments such as
      physiotherapy resulting in poor health outcomes. Beyond the immediate pain experience,
      children may also develop pain memory circuits. Procedural pain is still largely managed
      pharmacologically mostly through the use of opioids, benzodiazepines, and other
      pharmacological agents which cause a lot of side effects and do not always provide sufficient
      pain reduction. In recent years, the effectiveness of multimodal approaches combining
      medication with non-pharmacological interventions for procedural pain relief has been
      highlighte. Distraction techniques engaging multiple senses may grab the child's attention
      more than the techniques that only engage one sense (e.g, music), hence, the increasing
      interest in more immersive and interactive methods of distraction such as Virtual Reality
      (VR).

      VR is an active distraction method that allows the user to interact with an immersive
      environment generated by a computer stimulating different senses. A review of studies on VR,
      mostly conducted with adult burn patients, showed a 35 to 50% reduction in procedural pain
      while using VR. However, despite promising results, the use of VR in healthcare settings has
      been limited, mainly due to its high cost. Reviews have highlighted the need for more
      research but mostly for the development of more portable, less expensive and more developed
      VR systems that would promote pain reduction during burn procedures especially for children
      with burn injuries who are considered one of the most challenging burn populations. However,
      there has been a breakthrough in technology since 2014 when big scale companies started
      investing in VR development for commercial gaming. Facebook purchased the Oculus Rift (OR)
      for mass production allowing access to the latest technology in VR at a relatively low cost.
      OR is a VR tool that provides a wide field of view (FOV), high-resolution display, integrated
      3D audio and motion detection. In addition, it's highly immersive properties could help
      achieve more analgesia compared to other VR techniques as a review has shown that the sense
      of presence influences the effectiveness of VR-based analgesia. The sense of presence is a
      subjective psychological state of consciousness of being in the virtual world whereas
      immersiveness refers to the physical environment that could be quantified by measuring the
      field of view or the peripheral vision in the VR goggles. The availability of inexpensive yet
      highly immersive VR goggles such as OR could increase the use of VR in pain management and
      burn settings while significantly improving its cost-effectiveness. A single case study
      assessed the feasibility of a VR intervention via OR in one child of 11 years old with burn
      injuries during occupational therapy. The study showed a reduction in pain intensity and pain
      unpleasantness experienced by the patient, without any side effects. To our knowledge, no
      other studies have tested the feasibility of OR for procedural pain management in children
      with injuries undergoing painful physiotherapy treatments or wound care.

      AIM: The aim of this pilot clinical trial is to assess the acceptability and feasibility of
      VR distraction using the OR in children with injuries undergoing wound-related treatments
      (physiotherapy or dressing change). We also plan to evaluate the feasibility of the design
      and to predict appropriate sample size for a larger-scale clinical trial.

      METHODS:

      Design: Within-subject/crossover study design. Each child will serve as his own control and
      will receive both standard and experimental treatment during the same treatment session
      through a randomized order.

      Sample and Setting: Convenience sampling on the surgical-trauma unit at CHU Ste-Justine, of
      children presenting with an injury.

      Interventions. A) Standard pharmacological treatment as per the unit's protocol. B) VR
      distraction through the use of OR.The video games were developed by our team with a
      personalized care content tailored to the children's developmental stage and to maximize the
      feeling of immersion and minimize cybersickness, and approved by a team of healthcare
      professionals in pediatric care.

      Study proceedings: Physiotherapy sessions and dressing changes typically last between 20 to
      30 minutes. The duration will be divided into two sequences of the same duration (10 to 15
      minutes) where the participant receives the same care by the same healthcare professional.
      For one sequence, only the standard treatment will be administered and for the other
      sequence, patients will receive the standard treatment in addition to VR via OR in a
      randomized order.

      Measures: Pain and anxiety measures will be taken before the treatment session at (T1), after
      the first sequence of the session (T2) and after the second sequence of the session (T3)
      followed by a measure of nurses' satisfaction level via a questionnaire developed and
      pretested by the team. We will collect data on the average doses of analgesics administered
      before and during the session, and the side effects experienced in addition to the design's
      feasibility outcomes: participants recruited each month, adherence to study protocol.

      Data analysis: Quantitative analysis. Mean differences in pain scores between sequences will
      be compared using Wilcoxon test.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acceptability
time frame: T4, immediately after the procedure completion, before leaving the procedure room
description: To assess the acceptability including the satisfaction of healthcare professionals regarding the use of the VR distraction via Oculus Rift during the treatment session. Pre-tested tailored questionnaire including satisfaction and acceptability outcomes (tolerance, positive and negative aspects, secondary effects).
measure: Mean Pain Score
time frame: T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session
description: Numerical Rating Scale (NRS) ranging from 0 to 10; 0=no pain to 10=pain as bad as it could be
measure: Pain Experience
time frame: T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)
description: Graphic Rating Scale (GRS) consisting of seven items to measure the cognitive, the affective and the sensory components of pain
measure: Expected Anxiety
time frame: Baseline (T1)
description: Children's Fear Scale (CFS)
measure: Experienced Anxiety
time frame: T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)
description: Children's Fear Scale (CFS)
measure: Comfort Level
time frame: T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)
description: Behavioural observation scale of comfort level for child burn victims (OCCEB-BECCO)
measure: Pain Memory
time frame: 24 hours after the procedure (T5)
description: A measure of the child's memory of pain using the same measure (NRS) administered during the initial data collection to assess this construct
measure: Anxiety Memory
time frame: 24 hours after the procedure (T5)
description: A measure of the child's memory of anxiety using the same measure (CFS) administered during the initial data collection to assess this construct
measure: Range Of Motion
time frame: Baseline (T1); T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)
description: (only for physiotherapy sessions) Using a goniometer
arm group label: Standard pharmacological treatment
arm group type: Active Comparator
description: According to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and pain clinic nurse.
arm group label: VR distraction via Oculus Rift
arm group type: Experimental
description: In addition to standard pharmacological treatment, Virtual reality distraction through the use of Oculus Rift® will be used as the experimental intervention. The Oculus Rift (Consumer version) is made of two Oled panels with a resolution of 1200p running at 90Hz. It has very effective 360 degree positional tracking and integrated 3D audio. These combine to produce a high level of immersion, with high photorealism while maintaining the low latency necessary to induce presence and prevent cybersickness. The child, depending on the site of the injury, will have the opportunity to interact with the game. Video games, approved by healthcare professionals with extensive experience in pediatrics, were adapted for children and tailored to minimize cyber sickness.
intervention type: Device
intervention name: VR distraction via Oculus Rift
description: In addition to standard pharmacological treatment, Virtual reality distraction through the use of Oculus Rift® will be used as the experimental intervention. The Oculus Rift (Consumer version) is made of two Oled panels with a resolution of 1200p running at 90Hz. It has very effective 360 degree positional tracking and integrated 3D audio. These combine to produce a high level of immersion, with high photorealism while maintaining the low latency necessary to induce presence and prevent cybersickness. The child, depending on the site of the injury, will have the opportunity to interact with the game. Video games, approved by healthcare professionals with extensive experience in pediatrics, were adapted for children and tailored to minimize cyber sickness.
arm group label: VR distraction via Oculus Rift
intervention type: Other
intervention name: Standard pharmacological treatment
description: according to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and pain clinic nurse.
arm group label: Standard pharmacological treatment
criteria: 
gender: All
minimum age: 7 Years
maximum age: 18 Years
healthy volunteers: No
last name: Sylvie Le May, RN, PhD
role: Principal Investigator
affiliation: St. Justine's Hospital
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Justine's Hospital
investigator full name: Sylvie Le May
investigator title: RN, PhD
mesh term: Anxiety Disorders
sharing ipd: No