<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/NCT02986464</url>
  </required_header>
  <id_info>
    <org_study_id>2017-1382</org_study_id>
    <nct_id>NCT02986464</nct_id>
  </id_info>
  <brief_title>Virtual Reality Distraction for Procedural Pain Management in Children With Burn Injuries: a Randomized Controlled Trial</brief_title>
  <official_title>Virtual Reality Distraction for Procedural Pain Management in Children With Burn Injuries: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Justine's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Procedural pain is the most intense and often undertreated pain associated with burn&#xD;
      injuries. The use of analgesics does not always provide optimal relief and is accompanied by&#xD;
      several side effects. Indeed, children with burn injuries still experience severe pain&#xD;
      intensity during procedures despite the fact that doses of analgesics used with this&#xD;
      population has almost doubled in the last twenty years. 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. Distraction has been identified among the most effective&#xD;
      non-pharmacological interventions for pain as it diverts the child's attention to an&#xD;
      attractive element, hindering the perception of the painful stimuli. Virtual reality is a&#xD;
      method of active distraction that offers the child a multi-sensory immersive interaction that&#xD;
      found many applications for pain management in adult patients. However, very few studies have&#xD;
      tested the efficacy of distraction by virtual reality on procedural pain and anxiety in&#xD;
      children with burn injuries.&#xD;
&#xD;
      This RCT follows a pilot study (NCT02794103) aimed at assessing the feasibility of a virtual&#xD;
      reality prototype developed specifically for the hydrotherapy room of children under seven&#xD;
      years old for the relief of procedural pain in children with burn injuries. The aim of the&#xD;
      RCT will be to evaluate the effectiveness of the virtual reality prototype in relieving&#xD;
      procedural pain in children from 6 months to 7 years old undergoing hydrotherapy session for&#xD;
      burn injuries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND:&#xD;
&#xD;
      Preliminary data from the pilot study showed that the virtual reality prototype installed&#xD;
      around the tank in the hydrotherapy room is a feasible and acceptable method of distraction&#xD;
      that doesn't interfere with the work of healthcare professionals and could be used as a&#xD;
      non-pharmacological method for pain management. A clinical trial is needed to assess the&#xD;
      effectiveness of this intervention for procedural pain relief. The pilot study was also&#xD;
      informative about the feasibility of the study design and the measurement used. The methods&#xD;
      section was modified and adapted consequently for the upcoming trial.&#xD;
&#xD;
      METHODS:&#xD;
&#xD;
      Design: Within-subject/crossover study design. Each child will serve as their own control and&#xD;
      will receive both standard and experimental treatment during the same hydrotherapy session&#xD;
      through a randomized order.&#xD;
&#xD;
      Sample and Setting: Convenience sampling on the surgical-trauma burn unit at CHU Ste-Justine,&#xD;
      of children admitted to the unit or to the day hospital for a burn injury. The intervention&#xD;
      will take place in the hydrotherapy room of the CHU Ste-Justine.&#xD;
&#xD;
      Interventions. A) Standard pharmacological treatment as per the unit's protocol. B) VR&#xD;
      distraction through the use of a virtual reality prototype installed around the tank in the&#xD;
      hydrotherapy room. The prototype has been developed in collaboration with the Society of Arts&#xD;
      and Technology (SAT) in Montreal to provide an immersive interactive experience for the burn&#xD;
      child in the hydrotherapy tank. The prototype was developed after several meetings between&#xD;
      the researchers, the designers and engineers and the surgical trauma team of CHU Ste-Justine.&#xD;
      Meetings were followed by an ergonomic study of the hydrotherapy room to meet the unit's and&#xD;
      patients' specifications and ensure that it doesn't interfere with the healthcare&#xD;
      professionals work.The video games were developed by our team with a personalized care&#xD;
      content tailored to the children's developmental stage and to maximize the feeling of&#xD;
      immersion and minimize cybersickness, and approved by a team of healthcare professionals in&#xD;
      pediatric burn care.&#xD;
&#xD;
      Study proceedings: Hydrotherapy sessions typically last between 20 to 40 minutes. The&#xD;
      duration will be divided into two sequences of the same duration (10 to 20 minutes) where the&#xD;
      participant receives the same care by the same healthcare professional. For one sequence,&#xD;
      only the standard treatment will be administered and for the other sequence, patients will&#xD;
      receive the standard treatment in addition to Virtual Reality via the screen around the tank&#xD;
      in a randomized order.&#xD;
&#xD;
      Measures: Pain and anxiety measures will be taken before the treatment session at Baseline&#xD;
      (T1), in the middle of the first sequence of the session (T2) and in the middle of the second&#xD;
      sequence of the session (T3) followed by a measure of healthcare professionals' satisfaction&#xD;
      level via a questionnaire developed and pretested by the team after the session (T4). Data&#xD;
      will be collected on the average doses of analgesics administered before and during the&#xD;
      session, and the side effects experienced.&#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">May 3, 2018</start_date>
  <completion_date type="Actual">June 14, 2019</completion_date>
  <primary_completion_date type="Actual">June 14, 2019</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>Mean Pain Score</measure>
    <time_frame>T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)</time_frame>
    <description>French version of the Face, Legs, Activity, Cry and Consolability (FLACC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Pain Score - Observational/Behavioral Complementary measure</measure>
    <time_frame>T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)</time_frame>
    <description>Visual Analog Scale by proxy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort</measure>
    <time_frame>T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of 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>Sedation</measure>
    <time_frame>T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)</time_frame>
    <description>University of Michigan Sedation Scale (UMSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health professionals' satisfaction level</measure>
    <time_frame>T4: immediately after the procedure before leaving the hydrotherapy room</time_frame>
    <description>Pre-tested tailored questionnaire including tolerance, positive and negative aspects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic requirement</measure>
    <time_frame>T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)</time_frame>
    <description>Rescue dose medication administration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Burns</condition>
  <condition>Child</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Standard pharmacological treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual Reality distraction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality Prototype</intervention_name>
    <description>VR prototype installed around the tank in the hydrotherapy room to give the child a sense of immersion in the virtual world with a possibility of interaction depending on the child's age and condition.</description>
    <arm_group_label>Virtual Reality distraction</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 the 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 injury requiring a hydrotherapy session&#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 the hydrotherapy 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 burn injuries on the face preventing them from looking at the VR screen&#xD;
&#xD;
        Will be excluded in posteriori from analysis children sedated for more than 50% of the time&#xD;
        during one or both study sequences (score of 3 or 4 on the University of Michigan Sedation&#xD;
        Scale).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christelle Khadra, RN, PhD (c)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université de Montreal; CHU Ste-Justine Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sylvie Le May, RN, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Université de Montreal; CHU Ste-Justine Research Center</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>July 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>July 31, 2019</last_update_submitted>
  <last_update_submitted_qc>July 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2019</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, Professor, Université de Montréal</investigator_title>
  </responsible_party>
  <keyword>Virtual reality</keyword>
  <keyword>Immersive distraction</keyword>
  <keyword>Virtual world</keyword>
  <keyword>Virtual environment</keyword>
  <keyword>Procedural pain</keyword>
  <keyword>Acute pain</keyword>
  <keyword>Pain Management</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>Hydrotherapy</keyword>
  <keyword>Burn dressing</keyword>
  <keyword>Non-pharmacological</keyword>
  <keyword>Clinical Research</keyword>
  <keyword>Nursing Practice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Procedural</mesh_term>
    <mesh_term>Burns</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/NCT02986464
org study id: 2017-1382
nct id: NCT02986464
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Procedural pain is the most intense and often undertreated pain associated with burn
      injuries. The use of analgesics does not always provide optimal relief and is accompanied by
      several side effects. Indeed, children with burn injuries still experience severe pain
      intensity during procedures despite the fact that doses of analgesics used with this
      population has almost doubled in the last twenty years. 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. Distraction has been identified among the most effective
      non-pharmacological interventions for pain as it diverts the child's attention to an
      attractive element, hindering the perception of the painful stimuli. Virtual reality is a
      method of active distraction that offers the child a multi-sensory immersive interaction that
      found many applications for pain management in adult patients. However, very few studies have
      tested the efficacy of distraction by virtual reality on procedural pain and anxiety in
      children with burn injuries.

      This RCT follows a pilot study (NCT02794103) aimed at assessing the feasibility of a virtual
      reality prototype developed specifically for the hydrotherapy room of children under seven
      years old for the relief of procedural pain in children with burn injuries. The aim of the
      RCT will be to evaluate the effectiveness of the virtual reality prototype in relieving
      procedural pain in children from 6 months to 7 years old undergoing hydrotherapy session for
      burn injuries.
BACKGROUND:

      Preliminary data from the pilot study showed that the virtual reality prototype installed
      around the tank in the hydrotherapy room is a feasible and acceptable method of distraction
      that doesn't interfere with the work of healthcare professionals and could be used as a
      non-pharmacological method for pain management. A clinical trial is needed to assess the
      effectiveness of this intervention for procedural pain relief. The pilot study was also
      informative about the feasibility of the study design and the measurement used. The methods
      section was modified and adapted consequently for the upcoming trial.

      METHODS:

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

      Sample and Setting: Convenience sampling on the surgical-trauma burn unit at CHU Ste-Justine,
      of children admitted to the unit or to the day hospital for a burn injury. The intervention
      will take place in the hydrotherapy room of the CHU Ste-Justine.

      Interventions. A) Standard pharmacological treatment as per the unit's protocol. B) VR
      distraction through the use of a virtual reality prototype installed around the tank in the
      hydrotherapy room. The prototype has been developed in collaboration with the Society of Arts
      and Technology (SAT) in Montreal to provide an immersive interactive experience for the burn
      child in the hydrotherapy tank. The prototype was developed after several meetings between
      the researchers, the designers and engineers and the surgical trauma team of CHU Ste-Justine.
      Meetings were followed by an ergonomic study of the hydrotherapy room to meet the unit's and
      patients' specifications and ensure that it doesn't interfere with the healthcare
      professionals work.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 burn care.

      Study proceedings: Hydrotherapy sessions typically last between 20 to 40 minutes. The
      duration will be divided into two sequences of the same duration (10 to 20 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 Virtual Reality via the screen around the tank
      in a randomized order.

      Measures: Pain and anxiety measures will be taken before the treatment session at Baseline
      (T1), in the middle of the first sequence of the session (T2) and in the middle of the second
      sequence of the session (T3) followed by a measure of healthcare professionals' satisfaction
      level via a questionnaire developed and pretested by the team after the session (T4). Data
      will be collected on the average doses of analgesics administered before and during the
      session, and the side effects experienced.

      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: Mean Pain Score
time frame: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
description: French version of the Face, Legs, Activity, Cry and Consolability (FLACC)
measure: Mean Pain Score - Observational/Behavioral Complementary measure
time frame: T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
description: Visual Analog Scale by proxy
measure: Comfort
time frame: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
description: Behavioural observation scale of comfort level for child burn victims (OCCEB- BECCO)
measure: Sedation
time frame: T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
description: University of Michigan Sedation Scale (UMSS)
measure: Health professionals' satisfaction level
time frame: T4: immediately after the procedure before leaving the hydrotherapy room
description: Pre-tested tailored questionnaire including tolerance, positive and negative aspects
measure: Analgesic requirement
time frame: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
description: Rescue dose medication administration
arm group label: Standard pharmacological treatment
arm group type: Active Comparator
arm group label: Virtual Reality distraction
arm group type: Experimental
intervention type: Device
intervention name: Virtual Reality Prototype
description: VR prototype installed around the tank in the hydrotherapy room to give the child a sense of immersion in the virtual world with a possibility of interaction depending on the child's age and condition.
arm group label: Virtual Reality distraction
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 the pain clinic nurse.
arm group label: Standard pharmacological treatment
criteria: 
gender: All
minimum age: 6 Months
maximum age: 7 Years
healthy volunteers: No
last name: Christelle Khadra, RN, PhD (c)
role: Principal Investigator
affiliation: Université de Montreal; CHU Ste-Justine Research Center
last name: Sylvie Le May, RN, PhD
role: Study Director
affiliation: Université de Montreal; CHU Ste-Justine Research Center
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Justine's Hospital
investigator full name: Sylvie Le May
investigator title: RN, PhD, Professor, Université de Montréal
mesh term: Pain, Procedural
mesh term: Burns
sharing ipd: No