<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/NCT03750578</url>
  </required_header>
  <id_info>
    <org_study_id>2019-2074</org_study_id>
    <nct_id>NCT03750578</nct_id>
  </id_info>
  <brief_title>Virtual Reality for Needle Procedures in the Pediatric Emergency Department</brief_title>
  <acronym>DEVINCI</acronym>
  <official_title>Distraction in the Emergency Using Virtual Reality for Intravenous Needs in Children to Improve Comfort (DEVINCI): A Pilot 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>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>
      Venipuncture is a frequently performed painful and anxiogenic procedure in the paediatric&#xD;
      emergency department (PED). Topical anesthetic creams are used to reduce pain, but additional&#xD;
      modalities can modulate the nociceptive experience and distress associated with venipuncture.&#xD;
      Distraction can improve a patient's experience by mitigating their ability to focus on the&#xD;
      painful sensory input. Through its immersive nature, virtual reality (VR) has the potential&#xD;
      to distract patients from a 'real world' negative experience such as venipuncture. Given the&#xD;
      potential for short- and long-term consequences of poorly controlled pain and distress in&#xD;
      children, healthcare professionals must optimize patient comfort during medically required&#xD;
      procedures. The aim of this pilot pragmatic RCT study is to determine the feasibility,&#xD;
      acceptability and preliminary effect of a VR device (head-mounted Oculus Rift® (OR)) for pain&#xD;
      and distress reduction associated with venipuncture in the PED.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION Pain management of venipuncture in the Paediatric Emergency Department (PED)&#xD;
&#xD;
      Inadequate pain management in paediatrics is known to have significant short and long-term&#xD;
      consequences, such as negative memories, and greater pain perception during future&#xD;
      procedures. This can in turn lead to chronic healthcare avoidance, with potential&#xD;
      implications for increased morbidity. Suboptimal comfort plan is still consistently reported&#xD;
      in the literature Venipuncture is a frequently performed painful and anxiogenic procedure in&#xD;
      the paediatric emergency department (PED). It is among the most important causes of pain in&#xD;
      paediatric wards. This can be distressing for children, parents and healthcare workers (HCW).&#xD;
      Indeed, venipuncture is the leading cause of pain among hospitalized children. Up to 51% of&#xD;
      pre-adolescents reported high levels of distress associated with this procedure. Many&#xD;
      children reported moderate to severe procedural pain during their hospitalization according&#xD;
      to recent studies. Moreover, physiologic evidence of distress has been reported in caregivers&#xD;
      as they witness ED-based venipuncture in their child. Improved pain and distress management&#xD;
      during venipuncture can also significantly decrease distress in ED nurses performing the&#xD;
      procedure. It is therefore imperative to minimize the pain and distress associated with&#xD;
      venipuncture, especially in a stressful environment such as the PED. Therefore, multimodal&#xD;
      approaches are proposed, with combined strategies such as the four essential components by&#xD;
      Friedrichsdorf, which include the use of topical anaesthetics, sucrose in neonate,&#xD;
      comfortable positioning and distraction.&#xD;
&#xD;
      Pharmacological intervention: Topical anesthetics To reduce the discomfort generated by a&#xD;
      venipuncture, the use of a topical anaesthetic cream is recommended prior to needle&#xD;
      procedures, with options including EMLA ®, amethocaine and lidocaine. These products have&#xD;
      shown favourable results when the cream is applied prior to venipuncture and IV cannulation.&#xD;
      In the department, this strategy was introduced in 2013 and is available through a collective&#xD;
      order for nurses to use. The cream can be applied by a triage nurse suspecting that the child&#xD;
      will require venipuncture, or by the physician whose management plan includes a needle&#xD;
      puncture. Unfortunately, despite no real disadvantage to its application, this is a strategy&#xD;
      often forgotten by the treating team. At the study institution, the investigators use&#xD;
      Maxilene®. Its application is shorter than EMLA, only requiring a 30 minute wait, which is&#xD;
      often less than the time lapse, in the study PED, between the prescription of a venipuncture&#xD;
      and the actual intervention. Moreover, the anesthetic cream has been proven to improve&#xD;
      procedure success on first attempt and to shorten procedure time, compared to placebo.&#xD;
      Despite these advantages, this strategy remains scarcely used as mentioned above.&#xD;
&#xD;
      Physical intervention: Comfort Position Due to their developmental characteristics, it is&#xD;
      often difficult for children to rationally understand the indication for venipuncture.&#xD;
      Immobilization is therefore used in many instances - up to 74% of the time according to a&#xD;
      previous report - for intravenous (IV) placement or blood procuration. However, child&#xD;
      restrain should be avoided as much as possible. Despite the use of topical anesthetics,&#xD;
      venipuncture remains a traumatic experience for many children who are restrained. For this&#xD;
      reason, a sitting position is encouraged in the literature to increase the comfort of&#xD;
      paediatric patients during venipuncture.&#xD;
&#xD;
      Psychological intervention: Distraction Given the significant distress associated with&#xD;
      venipuncture despite improvement with the use of topical anesthetics and positioning, other&#xD;
      psychological adjuncts to pain management are important components of pain and distress&#xD;
      management related to needle procedures. Psychological interventions are recognized&#xD;
      strategies for pain and distress management in this setting, given their simplicity,&#xD;
      practicality, and at a relatively low cost. Side effects are usually absent to minimal.&#xD;
      Distraction is one such modality, based on the gate control theory, which improves a&#xD;
      patient's experience by mitigating their ability to focus on the painful sensory input.&#xD;
      Modalities such as the hide and find games ''I spy'', video games, bubbles, cartoons,&#xD;
      ''stress balls'', and other sensory modalities have been used as adjuncts to pain management&#xD;
      during venipuncture in children. The choice of modality depends on the setting and on the&#xD;
      child's developmental age. Effective distraction techniques focus on children empowerment&#xD;
      through attention to their preferences, using either active (eg. electronic games, ''I spy''&#xD;
      games) or passive (eg. music, video on television or tablet) distraction. In the study&#xD;
      department, distraction strategies have been improved in the recent years by the Equipe&#xD;
      Analgésie Urgence (EAU) team creating giant hide and find games in the procedure rooms and&#xD;
      introducing electronic tablets for use during procedures. Further, members of the study team&#xD;
      also studied other interventions done to distract children during painful procedures.&#xD;
&#xD;
      Through its immersive nature, virtual reality (VR) has the potential to effectively distract&#xD;
      patients from a ''real world'' negative experience such as venipuncture. It is hypothesized&#xD;
      that VR produces analgesia through inter-cortical modulation, which may explain decreases in&#xD;
      the pain matrix seen in functional magnetic resonance imaging of patients exposed to VR while&#xD;
      experiencing painful procedures.&#xD;
&#xD;
      Virtual reality in the PED Immersive virtual reality has been documented in different&#xD;
      settings, including burn units, hematology-oncology units, and orthopaedic procedural&#xD;
      sedation. A recent randomized control trial (RCT) demonstrated a reduction of procedural pain&#xD;
      and anxiety in patients 10-21 years old undergoing blood drawing at a phlebotomy outpatient&#xD;
      clinic. In the care of burn patients, VR was shown to improve patient experience and clinical&#xD;
      outcomes. To the investigators' knowledge there is no study on VR for procedural pain&#xD;
      management in the PED.&#xD;
&#xD;
      A recent review of VR in paediatric patients describes it as &quot;a promising new technology that&#xD;
      offers unique opportunities to modulate the experience of pain''. Potential side effects are&#xD;
      few and infrequent. These include visually induced motion sickness, a risk of collisions with&#xD;
      the surrounding environment, and a potential for creating ''false memories'' in younger&#xD;
      children. These potential side effects can be reduced by excluding younger children (&lt;7 years&#xD;
      old) until more suitable technologies are developed for this age group and also by working on&#xD;
      the code source of a video (when possible) to modulate speed, pop ups, and other animations&#xD;
      to better control for cyber-sicknesses.&#xD;
&#xD;
      Of note, the use of VR in healthcare settings has become more accessible due to the&#xD;
      development of more portable and affordable systems. In this study, the investigators will&#xD;
      use the Oculus Rift® (OR), which was purchased and mass produced by Facebook, allowing access&#xD;
      to the latest technology in VR at a relatively low cost. OR is a VR tool that provides a wide&#xD;
      field of view (FOV), high resolution display, integrated 3D audio and motion detection. In&#xD;
      addition, its highly immersive properties could help achieve more distraction compared to&#xD;
      other VR techniques as a review has shown that the sense of presence influences the&#xD;
      effectiveness of VR-based analgesia. Presence refers to a subjective psychological state of&#xD;
      consciousness of being in the virtual world. Immersiveness refers to the physical environment&#xD;
      that could be quantified by measuring the field of view or the peripheral vision in the VR&#xD;
      goggles.&#xD;
&#xD;
      The aims of this pilot RCT study is to address key areas (research design, methods, outcome&#xD;
      measures, sample size, etc.) prior to conducting a future definitive trial. The investigators&#xD;
      will therefore determine the acceptability and feasibility of a VR distraction using the OR&#xD;
      in children requiring venipuncture in PED. The investigators also plan to evaluate the&#xD;
      feasibility of the design and research methodology.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. To determine the feasibility and acceptability of VR distraction using the OR in&#xD;
           children undergoing venipuncture (IV line insertion or diagnostic venipuncture) in the&#xD;
           PED.&#xD;
&#xD;
        2. To examine the preliminary effect of VR compared to standard practice on children's pain&#xD;
           and distress related to venipuncture in the PED. Baseline estimate of the primary&#xD;
           outcome (pain) will also inform sample size calculation of the definitive trial.&#xD;
&#xD;
        3. To determine parents', children's, and healthcare workers' (HCW) satisfaction regarding&#xD;
           the use of VR for pain and distress management associated with venipuncture in the PED.&#xD;
&#xD;
        4. To determine feasibility and acceptability of the research design and methods including:&#xD;
           recruitment rate, randomization and allocation, outcome measures, delivery of the&#xD;
           interventions, rates of questionnaire completion, appropriateness of the inclusion&#xD;
           criteria, among others.&#xD;
&#xD;
      METHODS. Design. Pilot pragmatic randomized control study using a parallel design with two&#xD;
      groups: a) experimental group (VR+standard practice of needle-related pain management) or&#xD;
      control (standard practice of needle-related pain management) Setting. The research will be&#xD;
      conducted in a single ED, in a tertiary care paediatric university-affiliated hospital&#xD;
      (Université de Montréal), the CHU Sainte-Justine in Montreal from August 2018 to June 2019.&#xD;
      Sainte-Justine ED census is more than 80 000 patient-year.&#xD;
&#xD;
      Sample. Children from 7 to 17 years old who require venipuncture (IV line placement or&#xD;
      diagnostic venipuncture) as prescribed by an attending physician. Research nurses and&#xD;
      research assistants from the &quot;Programme Intégré d'Étudiants à l'Urgence Volontaires pour la&#xD;
      Recherche en Enfance de Sainte-Justine (PIEUVRES)&quot; will identify eligible families in the&#xD;
      waiting room of the ED using the institutional computerized database (between 8 AM and 8PM).&#xD;
      These research assistants will approach a convenience sample of participants during day or&#xD;
      evening shifts in the ED. Once they have accepted to participate and provided informed&#xD;
      parent's consent and child's assent, participating families will be enrolled in the study.&#xD;
&#xD;
      As this is a pilot study, no sample size calculation is required. The investigators will&#xD;
      randomize patients to one of the two intervention groups according to a list of randomization&#xD;
      generated by an independent biostatistician. The investigators aim to recruit a total of 60&#xD;
      participants (30 patients/group) who will be randomized among the two groups during the study&#xD;
      period. The investigators consider that this number would be adequate to provide information&#xD;
      regarding feasibility of the intervention and study process/measures. It is estimated that&#xD;
      close to 15 venipunctures are performed in the study department on a daily basis. The&#xD;
      investigators therefore expect to reach the sample size within 9 months of the study start.&#xD;
&#xD;
      Interventions. When venipuncture (either for IV line insertion or diagnostic venipuncture) is&#xD;
      prescribed by a physician, a topical anesthetic cream (Maxilene® 4 - Lidocaine 4%) will be&#xD;
      proposed to the patient, as standard of care. Usual positioning will be used by the staff&#xD;
      nurse.&#xD;
&#xD;
      A) RV : Patients in this group will be offered virtual reality distraction through the use of&#xD;
      OR. VR produces a high level of immersion, with high photorealism while maintaining the low&#xD;
      latency necessary to induce presence and prevent cyber-sickness symptoms such as nausea,&#xD;
      vomiting, headache. The video game was developed by the study team with three levels of&#xD;
      difficulty tailored to the children's developmental stages, and adapted to a hospital&#xD;
      environment, allowing control over its components designed to maximize the feeling of&#xD;
      immersion and minimize cyber-sickness symptoms. The game was approved by a team of healthcare&#xD;
      professionals involved in paediatric care. The game, oculus goggles and computer will be&#xD;
      available in the PED at the onset of the study. The oculus goggle will be adjusted to the&#xD;
      head of each child randomized to this group before any procedure and a period of 3 minutes&#xD;
      will be allotted prior to venipuncture. This will allow the child to get familiarized with&#xD;
      the game and immersed in the virtual environment (See photos in Annex).&#xD;
&#xD;
      B) Control intervention (standard of care): Patients in this group will receive standard&#xD;
      care, including the proposition to use topical anesthetic cream prior to venipuncture&#xD;
      attempt, usual distraction and positioning proposed by the treating nurse. Standard&#xD;
      behavioural techniques to relax children will be employed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Interventions. When venipuncture (either for IV line insertion or diagnostic venipuncture) is prescribed by a physician, a topical anesthetic cream (Maxilene® 4 - Lidocaine 4%) will be proposed to the patient, as standard of care. Usual positioning will be used by the staff nurse.&#xD;
A) Virtual reality: Patients in this group will be offered virtual reality distraction through the use of OR.&#xD;
B) Control intervention (standard of care): Patients in this group will receive standard care, including the proposition to use topical anesthetic cream prior to venipuncture attempt, usual distraction and positioning proposed by the treating nurse.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported pain during the procedure: Verbal Numerical Rating Scale (VNRS)</measure>
    <time_frame>This outcome will be measured within 2 minutes of the end of the procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used) by asking the child to rate their level of pain during the procedure.</time_frame>
    <description>The primary outcome of this study is the mean pain score felt during the procedure (self-report of pain level during the procedure) measured by the Verbal Numerical Rating Scale (VNRS).&#xD;
The VNRS consists of pain scale from 0 (no pain) to 10 (extreme pain). It is a well-established, valid, and reliable tool for the self-report of pain intensity in children as young as 6 years of age. This scale is widely used as it requires a lower degree of abstraction and less resources when compared to the Visual Analog Scale (VAS). The VNRS requires no physical tools, which explains its wide use in older children and adults with acute pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of overall pain management during venipuncture, with respect to pain relief, side effects, physical recovery, and emotional recovery.</measure>
    <time_frame>Measured within 5 minutes following the end procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used)</time_frame>
    <description>Individual 0 to 10 rating scales (without subscales), will be filled by the patient, parent and nurse present during the venipuncture.&#xD;
0 indicates &quot;not at all&quot;, whereas 10 indicated &quot;extremely&quot; with respect to the question asked. Participants can only choose integers between 0 and 10.&#xD;
The results obtained from this scale aim to inform the study team on the participants' perception of pain management received by children undergoing a venipuncture, with respect to pain relief, side effects, physical recovery, and emotional recovery.&#xD;
The question asked is the following:&#xD;
&quot;Considering pain relief, side effects, physical recovery, and emotional recovery, are you satisfied with the treatments your child received for pain? (0 = not at all, 10 = extremely)&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hetero-evaluation (by research nurse) of procedure-related distress</measure>
    <time_frame>Measured during the procedure (period between the start of physical restraint or needle/catheter insertion until needle/catheter removal from vein and end of physical restraint in patients where it was used)</time_frame>
    <description>Will be measured with the Procedure Behaviour Check List (PBCL). Consists of 8 sub-categories, graded 1 (very light) to 5 (extremely intense), for maximum of 40 points. According to a systematic review of observational measures of pain in children and adolescents, this scale was among the scales with the best balance of evidence, ease of use, and validity for the evaluation for pain-related distress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline pain score: Verbal Numerical Rating Scale (VNRS)</measure>
    <time_frame>Measured following recruitment and at most 10 minutes before the start of the procedure (before the start of physical restraint or needle/catheter insertion)</time_frame>
    <description>Self-report of pain level at baseline, measured by the Verbal Numerical Rating Scale (VNRS). 0 (no pain) to 10 (extreme pain) pain scale. The NRS is a well-established, valid, and reliable tool for the self-report of pain intensity in children as young as 6 years of age. This scale is widely used as it requires a lower degree of abstraction and less resources when compared to the VAS. The VNRS is even simpler, as it requires no physical tools, which explains its wide use in older children and adults with acute pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Auto-evaluation of post procedure-related distress</measure>
    <time_frame>Measured within 5 minutes following the end of the procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used)</time_frame>
    <description>Measured with the Child Fear Scale (CFS), a self-reported measure of anxiety adapted from the Faces Anxiety Scale (McKinley et al., 2003) for specific use in children undergoing painful experiences. It presents five faces ranging from 0 (no fear) through 4 (extremely fearful). The child is asked to indicate which face shows best how he/she feels during the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Auto-evaluation of baseline procedure-related distress</measure>
    <time_frame>Measured following recruitment and at most 10 minutes before the start of the procedure (before the start of physical restraint or needle/catheter insertion)</time_frame>
    <description>Measured with the Child Fear Scale (CFS), a self-reported measure of anxiety adapted from the Faces Anxiety Scale (McKinley et al., 2003) for specific use in children undergoing painful experiences. It presents five faces ranging from 0 (no fear) through 4 (extremely fearful). The child is asked to indicate which face shows best how he/she feels during the procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Procedural Anxiety</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Virtual Reality Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will be offered virtual reality distraction through the use of OR in addition to standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this group will receive standard care, including the proposition to use topical anesthetic cream prior to venipuncture attempt, usual distraction and positioning proposed by the treating nurse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual Reality goggle (Oculus Rift ® Helmet)</intervention_name>
    <description>as described</description>
    <arm_group_label>Virtual Reality Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Prescription of a venipuncture (IV line placement or diagnostic venipuncture) by an&#xD;
        attending physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable patient or urgent procedure required&#xD;
&#xD;
          -  Cognitive impairment that would render interaction with the VR game and/or answer to&#xD;
             the study questionaires unfeasable.&#xD;
&#xD;
          -  Diagnosis of epilepsy or any other condition precluding use of VR technology.&#xD;
&#xD;
          -  A parent is unavailable to provide consent for participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esli Osmanlliu, MD,FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency Department, UdM</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Evelyne D. Trottier, MD,FRCPC</last_name>
    <role>Study Director</role>
    <affiliation>Emergency Department, UdM</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sylvie Lemay, PhD</last_name>
    <role>Study Director</role>
    <affiliation>CHU Sainte-Justine Research Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Justine Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
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  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 9, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 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>Esli Osmanlliu</investigator_full_name>
    <investigator_title>Fellow, Pediatric Emergency Medicine</investigator_title>
  </responsible_party>
  <keyword>virtual reality</keyword>
  <keyword>procedural pain</keyword>
  <keyword>pediatric emergency department</keyword>
  <keyword>procedural anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</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/NCT03750578
org study id: 2019-2074
nct id: NCT03750578
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Venipuncture is a frequently performed painful and anxiogenic procedure in the paediatric
      emergency department (PED). Topical anesthetic creams are used to reduce pain, but additional
      modalities can modulate the nociceptive experience and distress associated with venipuncture.
      Distraction can improve a patient's experience by mitigating their ability to focus on the
      painful sensory input. Through its immersive nature, virtual reality (VR) has the potential
      to distract patients from a 'real world' negative experience such as venipuncture. Given the
      potential for short- and long-term consequences of poorly controlled pain and distress in
      children, healthcare professionals must optimize patient comfort during medically required
      procedures. The aim of this pilot pragmatic RCT study is to determine the feasibility,
      acceptability and preliminary effect of a VR device (head-mounted Oculus Rift® (OR)) for pain
      and distress reduction associated with venipuncture in the PED.
INTRODUCTION Pain management of venipuncture in the Paediatric Emergency Department (PED)

      Inadequate pain management in paediatrics is known to have significant short and long-term
      consequences, such as negative memories, and greater pain perception during future
      procedures. This can in turn lead to chronic healthcare avoidance, with potential
      implications for increased morbidity. Suboptimal comfort plan is still consistently reported
      in the literature Venipuncture is a frequently performed painful and anxiogenic procedure in
      the paediatric emergency department (PED). It is among the most important causes of pain in
      paediatric wards. This can be distressing for children, parents and healthcare workers (HCW).
      Indeed, venipuncture is the leading cause of pain among hospitalized children. Up to 51% of
      pre-adolescents reported high levels of distress associated with this procedure. Many
      children reported moderate to severe procedural pain during their hospitalization according
      to recent studies. Moreover, physiologic evidence of distress has been reported in caregivers
      as they witness ED-based venipuncture in their child. Improved pain and distress management
      during venipuncture can also significantly decrease distress in ED nurses performing the
      procedure. It is therefore imperative to minimize the pain and distress associated with
      venipuncture, especially in a stressful environment such as the PED. Therefore, multimodal
      approaches are proposed, with combined strategies such as the four essential components by
      Friedrichsdorf, which include the use of topical anaesthetics, sucrose in neonate,
      comfortable positioning and distraction.

      Pharmacological intervention: Topical anesthetics To reduce the discomfort generated by a
      venipuncture, the use of a topical anaesthetic cream is recommended prior to needle
      procedures, with options including EMLA ®, amethocaine and lidocaine. These products have
      shown favourable results when the cream is applied prior to venipuncture and IV cannulation.
      In the department, this strategy was introduced in 2013 and is available through a collective
      order for nurses to use. The cream can be applied by a triage nurse suspecting that the child
      will require venipuncture, or by the physician whose management plan includes a needle
      puncture. Unfortunately, despite no real disadvantage to its application, this is a strategy
      often forgotten by the treating team. At the study institution, the investigators use
      Maxilene®. Its application is shorter than EMLA, only requiring a 30 minute wait, which is
      often less than the time lapse, in the study PED, between the prescription of a venipuncture
      and the actual intervention. Moreover, the anesthetic cream has been proven to improve
      procedure success on first attempt and to shorten procedure time, compared to placebo.
      Despite these advantages, this strategy remains scarcely used as mentioned above.

      Physical intervention: Comfort Position Due to their developmental characteristics, it is
      often difficult for children to rationally understand the indication for venipuncture.
      Immobilization is therefore used in many instances - up to 74% of the time according to a
      previous report - for intravenous (IV) placement or blood procuration. However, child
      restrain should be avoided as much as possible. Despite the use of topical anesthetics,
      venipuncture remains a traumatic experience for many children who are restrained. For this
      reason, a sitting position is encouraged in the literature to increase the comfort of
      paediatric patients during venipuncture.

      Psychological intervention: Distraction Given the significant distress associated with
      venipuncture despite improvement with the use of topical anesthetics and positioning, other
      psychological adjuncts to pain management are important components of pain and distress
      management related to needle procedures. Psychological interventions are recognized
      strategies for pain and distress management in this setting, given their simplicity,
      practicality, and at a relatively low cost. Side effects are usually absent to minimal.
      Distraction is one such modality, based on the gate control theory, which improves a
      patient's experience by mitigating their ability to focus on the painful sensory input.
      Modalities such as the hide and find games ''I spy'', video games, bubbles, cartoons,
      ''stress balls'', and other sensory modalities have been used as adjuncts to pain management
      during venipuncture in children. The choice of modality depends on the setting and on the
      child's developmental age. Effective distraction techniques focus on children empowerment
      through attention to their preferences, using either active (eg. electronic games, ''I spy''
      games) or passive (eg. music, video on television or tablet) distraction. In the study
      department, distraction strategies have been improved in the recent years by the Equipe
      Analgésie Urgence (EAU) team creating giant hide and find games in the procedure rooms and
      introducing electronic tablets for use during procedures. Further, members of the study team
      also studied other interventions done to distract children during painful procedures.

      Through its immersive nature, virtual reality (VR) has the potential to effectively distract
      patients from a ''real world'' negative experience such as venipuncture. It is hypothesized
      that VR produces analgesia through inter-cortical modulation, which may explain decreases in
      the pain matrix seen in functional magnetic resonance imaging of patients exposed to VR while
      experiencing painful procedures.

      Virtual reality in the PED Immersive virtual reality has been documented in different
      settings, including burn units, hematology-oncology units, and orthopaedic procedural
      sedation. A recent randomized control trial (RCT) demonstrated a reduction of procedural pain
      and anxiety in patients 10-21 years old undergoing blood drawing at a phlebotomy outpatient
      clinic. In the care of burn patients, VR was shown to improve patient experience and clinical
      outcomes. To the investigators' knowledge there is no study on VR for procedural pain
      management in the PED.

      A recent review of VR in paediatric patients describes it as "a promising new technology that
      offers unique opportunities to modulate the experience of pain''. Potential side effects are
      few and infrequent. These include visually induced motion sickness, a risk of collisions with
      the surrounding environment, and a potential for creating ''false memories'' in younger
      children. These potential side effects can be reduced by excluding younger children (<7 years
      old) until more suitable technologies are developed for this age group and also by working on
      the code source of a video (when possible) to modulate speed, pop ups, and other animations
      to better control for cyber-sicknesses.

      Of note, the use of VR in healthcare settings has become more accessible due to the
      development of more portable and affordable systems. In this study, the investigators will
      use the Oculus Rift® (OR), which was purchased and mass produced by Facebook, 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, its highly immersive properties could help achieve more distraction compared to
      other VR techniques as a review has shown that the sense of presence influences the
      effectiveness of VR-based analgesia. Presence refers to a subjective psychological state of
      consciousness of being in the virtual world. 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 aims of this pilot RCT study is to address key areas (research design, methods, outcome
      measures, sample size, etc.) prior to conducting a future definitive trial. The investigators
      will therefore determine the acceptability and feasibility of a VR distraction using the OR
      in children requiring venipuncture in PED. The investigators also plan to evaluate the
      feasibility of the design and research methodology.

      Objectives:

        1. To determine the feasibility and acceptability of VR distraction using the OR in
           children undergoing venipuncture (IV line insertion or diagnostic venipuncture) in the
           PED.

        2. To examine the preliminary effect of VR compared to standard practice on children's pain
           and distress related to venipuncture in the PED. Baseline estimate of the primary
           outcome (pain) will also inform sample size calculation of the definitive trial.

        3. To determine parents', children's, and healthcare workers' (HCW) satisfaction regarding
           the use of VR for pain and distress management associated with venipuncture in the PED.

        4. To determine feasibility and acceptability of the research design and methods including:
           recruitment rate, randomization and allocation, outcome measures, delivery of the
           interventions, rates of questionnaire completion, appropriateness of the inclusion
           criteria, among others.

      METHODS. Design. Pilot pragmatic randomized control study using a parallel design with two
      groups: a) experimental group (VR+standard practice of needle-related pain management) or
      control (standard practice of needle-related pain management) Setting. The research will be
      conducted in a single ED, in a tertiary care paediatric university-affiliated hospital
      (Université de Montréal), the CHU Sainte-Justine in Montreal from August 2018 to June 2019.
      Sainte-Justine ED census is more than 80 000 patient-year.

      Sample. Children from 7 to 17 years old who require venipuncture (IV line placement or
      diagnostic venipuncture) as prescribed by an attending physician. Research nurses and
      research assistants from the "Programme Intégré d'Étudiants à l'Urgence Volontaires pour la
      Recherche en Enfance de Sainte-Justine (PIEUVRES)" will identify eligible families in the
      waiting room of the ED using the institutional computerized database (between 8 AM and 8PM).
      These research assistants will approach a convenience sample of participants during day or
      evening shifts in the ED. Once they have accepted to participate and provided informed
      parent's consent and child's assent, participating families will be enrolled in the study.

      As this is a pilot study, no sample size calculation is required. The investigators will
      randomize patients to one of the two intervention groups according to a list of randomization
      generated by an independent biostatistician. The investigators aim to recruit a total of 60
      participants (30 patients/group) who will be randomized among the two groups during the study
      period. The investigators consider that this number would be adequate to provide information
      regarding feasibility of the intervention and study process/measures. It is estimated that
      close to 15 venipunctures are performed in the study department on a daily basis. The
      investigators therefore expect to reach the sample size within 9 months of the study start.

      Interventions. When venipuncture (either for IV line insertion or diagnostic venipuncture) is
      prescribed by a physician, a topical anesthetic cream (Maxilene® 4 - Lidocaine 4%) will be
      proposed to the patient, as standard of care. Usual positioning will be used by the staff
      nurse.

      A) RV : Patients in this group will be offered virtual reality distraction through the use of
      OR. VR produces a high level of immersion, with high photorealism while maintaining the low
      latency necessary to induce presence and prevent cyber-sickness symptoms such as nausea,
      vomiting, headache. The video game was developed by the study team with three levels of
      difficulty tailored to the children's developmental stages, and adapted to a hospital
      environment, allowing control over its components designed to maximize the feeling of
      immersion and minimize cyber-sickness symptoms. The game was approved by a team of healthcare
      professionals involved in paediatric care. The game, oculus goggles and computer will be
      available in the PED at the onset of the study. The oculus goggle will be adjusted to the
      head of each child randomized to this group before any procedure and a period of 3 minutes
      will be allotted prior to venipuncture. This will allow the child to get familiarized with
      the game and immersed in the virtual environment (See photos in Annex).

      B) Control intervention (standard of care): Patients in this group will receive standard
      care, including the proposition to use topical anesthetic cream prior to venipuncture
      attempt, usual distraction and positioning proposed by the treating nurse. Standard
      behavioural techniques to relax children will be employed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Interventions. When venipuncture (either for IV line insertion or diagnostic venipuncture) is prescribed by a physician, a topical anesthetic cream (Maxilene® 4 - Lidocaine 4%) will be proposed to the patient, as standard of care. Usual positioning will be used by the staff nurse.
A) Virtual reality: Patients in this group will be offered virtual reality distraction through the use of OR.
B) Control intervention (standard of care): Patients in this group will receive standard care, including the proposition to use topical anesthetic cream prior to venipuncture attempt, usual distraction and positioning proposed by the treating nurse.
primary purpose: Other
masking: None (Open Label)
measure: Self-reported pain during the procedure: Verbal Numerical Rating Scale (VNRS)
time frame: This outcome will be measured within 2 minutes of the end of the procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used) by asking the child to rate their level of pain during the procedure.
description: The primary outcome of this study is the mean pain score felt during the procedure (self-report of pain level during the procedure) measured by the Verbal Numerical Rating Scale (VNRS).
The VNRS consists of pain scale from 0 (no pain) to 10 (extreme pain). It is a well-established, valid, and reliable tool for the self-report of pain intensity in children as young as 6 years of age. This scale is widely used as it requires a lower degree of abstraction and less resources when compared to the Visual Analog Scale (VAS). The VNRS requires no physical tools, which explains its wide use in older children and adults with acute pain.
measure: Evaluation of overall pain management during venipuncture, with respect to pain relief, side effects, physical recovery, and emotional recovery.
time frame: Measured within 5 minutes following the end procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used)
description: Individual 0 to 10 rating scales (without subscales), will be filled by the patient, parent and nurse present during the venipuncture.
0 indicates "not at all", whereas 10 indicated "extremely" with respect to the question asked. Participants can only choose integers between 0 and 10.
The results obtained from this scale aim to inform the study team on the participants' perception of pain management received by children undergoing a venipuncture, with respect to pain relief, side effects, physical recovery, and emotional recovery.
The question asked is the following:
"Considering pain relief, side effects, physical recovery, and emotional recovery, are you satisfied with the treatments your child received for pain? (0 = not at all, 10 = extremely)"
measure: Hetero-evaluation (by research nurse) of procedure-related distress
time frame: Measured during the procedure (period between the start of physical restraint or needle/catheter insertion until needle/catheter removal from vein and end of physical restraint in patients where it was used)
description: Will be measured with the Procedure Behaviour Check List (PBCL). Consists of 8 sub-categories, graded 1 (very light) to 5 (extremely intense), for maximum of 40 points. According to a systematic review of observational measures of pain in children and adolescents, this scale was among the scales with the best balance of evidence, ease of use, and validity for the evaluation for pain-related distress
measure: Baseline pain score: Verbal Numerical Rating Scale (VNRS)
time frame: Measured following recruitment and at most 10 minutes before the start of the procedure (before the start of physical restraint or needle/catheter insertion)
description: Self-report of pain level at baseline, measured by the Verbal Numerical Rating Scale (VNRS). 0 (no pain) to 10 (extreme pain) pain scale. The NRS is a well-established, valid, and reliable tool for the self-report of pain intensity in children as young as 6 years of age. This scale is widely used as it requires a lower degree of abstraction and less resources when compared to the VAS. The VNRS is even simpler, as it requires no physical tools, which explains its wide use in older children and adults with acute pain.
measure: Auto-evaluation of post procedure-related distress
time frame: Measured within 5 minutes following the end of the procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used)
description: Measured with the Child Fear Scale (CFS), a self-reported measure of anxiety adapted from the Faces Anxiety Scale (McKinley et al., 2003) for specific use in children undergoing painful experiences. It presents five faces ranging from 0 (no fear) through 4 (extremely fearful). The child is asked to indicate which face shows best how he/she feels during the procedure.
measure: Auto-evaluation of baseline procedure-related distress
time frame: Measured following recruitment and at most 10 minutes before the start of the procedure (before the start of physical restraint or needle/catheter insertion)
description: Measured with the Child Fear Scale (CFS), a self-reported measure of anxiety adapted from the Faces Anxiety Scale (McKinley et al., 2003) for specific use in children undergoing painful experiences. It presents five faces ranging from 0 (no fear) through 4 (extremely fearful). The child is asked to indicate which face shows best how he/she feels during the procedure.
arm group label: Virtual Reality Group
arm group type: Experimental
description: Patients in this group will be offered virtual reality distraction through the use of OR in addition to standard of care.
arm group label: Standard of care group
arm group type: No Intervention
description: Patients in this group will receive standard care, including the proposition to use topical anesthetic cream prior to venipuncture attempt, usual distraction and positioning proposed by the treating nurse.
intervention type: Behavioral
intervention name: Virtual Reality goggle (Oculus Rift ® Helmet)
description: as described
arm group label: Virtual Reality Group
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Esli Osmanlliu, MD,FRCPC
role: Principal Investigator
affiliation: Emergency Department, UdM
last name: Evelyne D. Trottier, MD,FRCPC
role: Study Director
affiliation: Emergency Department, UdM
last name: Sylvie Lemay, PhD
role: Study Director
affiliation: CHU Sainte-Justine Research Centre
facility: 
country: Canada
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PMID: 25227643
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responsible party type: Principal Investigator
investigator affiliation: St. Justine's Hospital
investigator full name: Esli Osmanlliu
investigator title: Fellow, Pediatric Emergency Medicine
mesh term: Emergencies
sharing ipd: No