<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/NCT03239743</url>
  </required_header>
  <id_info>
    <org_study_id>17-025</org_study_id>
    <nct_id>NCT03239743</nct_id>
  </id_info>
  <brief_title>Effects of Virtual Reality on Pre-Operative Anxiety and Induction of Anesthesia in Children and Adolescents</brief_title>
  <official_title>A Pilot Study to Evaluate the Efficacy of Virtual Reality on Pre-Operative Anxiety and Induction of Anesthesia in a Children's Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Valley Anesthesiology Consultants</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KindVR</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Phoenix Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Valley Anesthesiology Consultants</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain and anxiety have a direct correlation. Patients who experience anxiety are more&#xD;
      susceptible to feeling pain, and patients who experience pain are more likely to have a&#xD;
      component of anxiety associated with their pain. A common technique used by pain&#xD;
      psychologists to help minimize pain is distraction. Different forms of distraction include&#xD;
      video games, movies, music, etc. Recently, doctors and researchers around the world have&#xD;
      begun experimenting with Virtual Reality as a distraction technique.&#xD;
&#xD;
      A review of the use of virtual reality compared to the current standard of care may help&#xD;
      uncover important trends regarding anxiety, postoperative pain and analgesic use in patients&#xD;
      who undergo a tonsillectomy or a tonsillectomy and adenoidectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are approximately five million pediatric surgeries performed in the United States every&#xD;
      year, and approximately 50% of pediatric patients experience significant stress and anxiety&#xD;
      before their surgery. High anxiety can result in increased postoperative pain, increased&#xD;
      analgesic consumption, and delayed recovery. The perception of pain can have a strong&#xD;
      psychological component and can increase if the patient gives the area of injury constant&#xD;
      attention. Thus, different distraction techniques have been utilized by pain psychologists to&#xD;
      take the patient's attention away from the area of injury.&#xD;
&#xD;
      Pharmacological intervention to treat preoperative anxiety in children has its own&#xD;
      side-effect profile. Midazolam is a common medication used parentally, nasally, or orally to&#xD;
      alleviate preoperative anxiety. However, there are many side-effects that are not always&#xD;
      preventable. Reports of 3.8% of patients having paradoxical effects from midazolam have been&#xD;
      documented, and delayed emergence is possible in surgeries of short duration. In addition,&#xD;
      midazolam can also result in critical events perioperatively, such as airway obstruction and&#xD;
      worsened nausea and vomiting. Non-pharmacological interventions could help avoid these&#xD;
      complications, however, current studies do not show a viable alternative to a pharmacological&#xD;
      interventions.&#xD;
&#xD;
      Virtual Reality (VR) is a technology that allows individuals to experience a virtual world.&#xD;
      VR initially began as a form of entertainment, but it has expanded its application into&#xD;
      several other areas. Within the past 10 years, this type of technology has been applied&#xD;
      clinically as a method of distraction for medical procedures such as chemotherapy, physical&#xD;
      therapy, burn wound changes, and surgery. VR allows the patients to be immersed in an&#xD;
      interactive world stimulating sights, sounds, and motion to help enhance the distraction from&#xD;
      pain, ultimately reducing anxiety. A small validation study was conducted at the Virtual&#xD;
      Reality Medical Center to test the usability and safety in patients with chronic pain.&#xD;
      Patients were presented with pleasant relaxing scenes including natural areas like forests,&#xD;
      beaches, and mountains, with relaxing and soothing effects to help mimic slowed breathing.&#xD;
      Researchers in this study found that the pain distraction virtual environment (VE) was easy&#xD;
      to use, had good stereo sound effects, and was immersive and interactive. They also found&#xD;
      that patients experienced low levels of fatigue, headache, eyestrain, and nausea when using&#xD;
      the VR device. No studies have involved VR in setting of anesthesia induction period and a&#xD;
      non-pharmacological intervention for preoperative anxiety.&#xD;
&#xD;
      A pilot study conducted by Wiederhold et al, tested 6 chronic pain patients using a&#xD;
      head-mounted VR device. All six study participants reported a significant drop in pain while&#xD;
      using the natural VE. Similarly, a study from the University of Washington found that&#xD;
      children playing VR video games or navigating through a virtual environment while receiving&#xD;
      wound care for their burns had lower pain scores than patients who just played video games.&#xD;
      Another study conducted by Wiederhold et al., looked at fear and pain before and after dental&#xD;
      treatment and found a significant decrease in pain perception and stated anxiety scores in&#xD;
      patients using the VR eyeglasses compared to the nonuse group.&#xD;
&#xD;
      Based on success in other medical procedures, we propose a study to examine the efficacy and&#xD;
      feasibility of using VR during induction of anesthesia to help minimize anxiety,&#xD;
      postoperative pain and analgesic use in patients undergoing a tonsillectomy or a&#xD;
      tonsillectomy and adenoidectomy procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">May 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pre-Operative Anxiety measured by mYPAS anxiety scores</measure>
    <time_frame>Baseline</time_frame>
    <description>Determine if the use of a VR device will result in lower mYPAS anxiety scores during the preoperative period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Induction Compliance of Anesthesia measured by the induction compliance checklist</measure>
    <time_frame>Baseline</time_frame>
    <description>Determine if the use of a VR device will result in greater induction of anesthesia measured by the induction compliance checklist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Operative Emergence Delirium measured by the PAED scale</measure>
    <time_frame>up to 3 hours post operative</time_frame>
    <description>Determine if VR use will reduce incidence of post-operative emergence delirium measured by the PAED scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Operative Pain</measure>
    <time_frame>up to 3 hours post operative</time_frame>
    <description>Measure if VR use will reduce post-operative pain scores compared to patients receiving standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Operative Opioid Use</measure>
    <time_frame>up to 3 hours post operative</time_frame>
    <description>Measure VR use will reduce opioid use compared to patients receiving standard of care</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Tonsillectomy</condition>
  <arm_group>
    <arm_group_label>Virtual Reality Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be given the virtual reality device to interact with prior to surgery without the use of a pre-medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Midazolam Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be given the drug Midazolam to help alleviate the pre-operative anxiety.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality</intervention_name>
    <description>Child will wear and interact with virtual reality headset while waiting for surgery.</description>
    <arm_group_label>Virtual Reality Group</arm_group_label>
    <other_name>KindVR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>Child will receive Midazolam to help with pre-operative anxiety prior to surgery</description>
    <arm_group_label>Midazolam Group</arm_group_label>
    <other_name>Versed</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient undergoing tonsillectomy or tonsillectomy and adenoidectomy procedure&#xD;
&#xD;
          -  Must be between the ages of 5 and 11 years&#xD;
&#xD;
          -  Anxious/moderate anxiety patients (mYPAS greater than or equal to 30)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient with preoperative peripherally placed IV&#xD;
&#xD;
          -  Any patient who is cognitively impaired&#xD;
&#xD;
          -  Any patient with a previous surgery&#xD;
&#xD;
          -  ASA Physical Status higher than II&#xD;
&#xD;
          -  Body Mass Index &gt;30&#xD;
&#xD;
          -  A history of affective disorder, attention disorder, or psychotropic medication use&#xD;
&#xD;
          -  Calm/low anxiety patients (mYPAS less than 30)&#xD;
&#xD;
          -  Deaf or blind&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Vanessa Pohl, B.S.</last_name>
    <phone>602-933-4482</phone>
    <email>vpohl@phoenixchildrens.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Phoenix Children's Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raj Singhal, M.D.</last_name>
      <phone>602-933-4482</phone>
      <email>rsinghal@valley.md</email>
    </contact>
    <contact_backup>
      <last_name>Vanessa Pohl, B.S.</last_name>
      <phone>6029334482</phone>
      <email>vpohl@phoenixchildrens.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.</citation>
    <PMID>19272275</PMID>
  </reference>
  <reference>
    <citation>Wiederhold BK, Gao K, Sulea C, Wiederhold MD. Virtual reality as a distraction technique in chronic pain patients. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):346-52. doi: 10.1089/cyber.2014.0207.</citation>
    <PMID>24892196</PMID>
  </reference>
  <reference>
    <citation>Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.</citation>
    <PMID>16882820</PMID>
  </reference>
  <reference>
    <citation>Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.</citation>
    <PMID>8953995</PMID>
  </reference>
  <reference>
    <citation>Wiederhold MD, Gao K, Wiederhold BK. Clinical use of virtual reality distraction system to reduce anxiety and pain in dental procedures. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):359-65. doi: 10.1089/cyber.2014.0203.</citation>
    <PMID>24892198</PMID>
  </reference>
  <reference>
    <citation>Mosso-Vazquez JL, Gao K, Wiederhold BK, Wiederhold MD. Virtual reality for pain management in cardiac surgery. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):371-8. doi: 10.1089/cyber.2014.0198.</citation>
    <PMID>24892200</PMID>
  </reference>
  <reference>
    <citation>Wiederhold BK, Soomro A, Riva G, Wiederhold MD. Future directions: advances and implications of virtual environments designed for pain management. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):414-22. doi: 10.1089/cyber.2014.0197.</citation>
    <PMID>24892206</PMID>
  </reference>
  <reference>
    <citation>Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.</citation>
    <PMID>21264690</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>April 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>October 17, 2018</last_update_submitted>
  <last_update_submitted_qc>October 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Valley Anesthesiology Consultants</investigator_affiliation>
    <investigator_full_name>Neil Raj Singhal</investigator_full_name>
    <investigator_title>Pain Management Research Director</investigator_title>
  </responsible_party>
  <keyword>virtual reality</keyword>
  <keyword>adenoidectomy</keyword>
  <keyword>induction of anesthesia</keyword>
  <keyword>pre-operative anxiety</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
  </intervention_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/NCT03239743
org study id: 17-025
nct id: NCT03239743
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Pain and anxiety have a direct correlation. Patients who experience anxiety are more
      susceptible to feeling pain, and patients who experience pain are more likely to have a
      component of anxiety associated with their pain. A common technique used by pain
      psychologists to help minimize pain is distraction. Different forms of distraction include
      video games, movies, music, etc. Recently, doctors and researchers around the world have
      begun experimenting with Virtual Reality as a distraction technique.

      A review of the use of virtual reality compared to the current standard of care may help
      uncover important trends regarding anxiety, postoperative pain and analgesic use in patients
      who undergo a tonsillectomy or a tonsillectomy and adenoidectomy.
There are approximately five million pediatric surgeries performed in the United States every
      year, and approximately 50% of pediatric patients experience significant stress and anxiety
      before their surgery. High anxiety can result in increased postoperative pain, increased
      analgesic consumption, and delayed recovery. The perception of pain can have a strong
      psychological component and can increase if the patient gives the area of injury constant
      attention. Thus, different distraction techniques have been utilized by pain psychologists to
      take the patient's attention away from the area of injury.

      Pharmacological intervention to treat preoperative anxiety in children has its own
      side-effect profile. Midazolam is a common medication used parentally, nasally, or orally to
      alleviate preoperative anxiety. However, there are many side-effects that are not always
      preventable. Reports of 3.8% of patients having paradoxical effects from midazolam have been
      documented, and delayed emergence is possible in surgeries of short duration. In addition,
      midazolam can also result in critical events perioperatively, such as airway obstruction and
      worsened nausea and vomiting. Non-pharmacological interventions could help avoid these
      complications, however, current studies do not show a viable alternative to a pharmacological
      interventions.

      Virtual Reality (VR) is a technology that allows individuals to experience a virtual world.
      VR initially began as a form of entertainment, but it has expanded its application into
      several other areas. Within the past 10 years, this type of technology has been applied
      clinically as a method of distraction for medical procedures such as chemotherapy, physical
      therapy, burn wound changes, and surgery. VR allows the patients to be immersed in an
      interactive world stimulating sights, sounds, and motion to help enhance the distraction from
      pain, ultimately reducing anxiety. A small validation study was conducted at the Virtual
      Reality Medical Center to test the usability and safety in patients with chronic pain.
      Patients were presented with pleasant relaxing scenes including natural areas like forests,
      beaches, and mountains, with relaxing and soothing effects to help mimic slowed breathing.
      Researchers in this study found that the pain distraction virtual environment (VE) was easy
      to use, had good stereo sound effects, and was immersive and interactive. They also found
      that patients experienced low levels of fatigue, headache, eyestrain, and nausea when using
      the VR device. No studies have involved VR in setting of anesthesia induction period and a
      non-pharmacological intervention for preoperative anxiety.

      A pilot study conducted by Wiederhold et al, tested 6 chronic pain patients using a
      head-mounted VR device. All six study participants reported a significant drop in pain while
      using the natural VE. Similarly, a study from the University of Washington found that
      children playing VR video games or navigating through a virtual environment while receiving
      wound care for their burns had lower pain scores than patients who just played video games.
      Another study conducted by Wiederhold et al., looked at fear and pain before and after dental
      treatment and found a significant decrease in pain perception and stated anxiety scores in
      patients using the VR eyeglasses compared to the nonuse group.

      Based on success in other medical procedures, we propose a study to examine the efficacy and
      feasibility of using VR during induction of anesthesia to help minimize anxiety,
      postoperative pain and analgesic use in patients undergoing a tonsillectomy or a
      tonsillectomy and adenoidectomy procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pre-Operative Anxiety measured by mYPAS anxiety scores
time frame: Baseline
description: Determine if the use of a VR device will result in lower mYPAS anxiety scores during the preoperative period
measure: Induction Compliance of Anesthesia measured by the induction compliance checklist
time frame: Baseline
description: Determine if the use of a VR device will result in greater induction of anesthesia measured by the induction compliance checklist.
measure: Post-Operative Emergence Delirium measured by the PAED scale
time frame: up to 3 hours post operative
description: Determine if VR use will reduce incidence of post-operative emergence delirium measured by the PAED scale.
measure: Post-Operative Pain
time frame: up to 3 hours post operative
description: Measure if VR use will reduce post-operative pain scores compared to patients receiving standard of care.
measure: Post-Operative Opioid Use
time frame: up to 3 hours post operative
description: Measure VR use will reduce opioid use compared to patients receiving standard of care
arm group label: Virtual Reality Group
arm group type: Experimental
description: Subjects will be given the virtual reality device to interact with prior to surgery without the use of a pre-medication.
arm group label: Midazolam Group
arm group type: Active Comparator
description: Subjects will be given the drug Midazolam to help alleviate the pre-operative anxiety.
intervention type: Device
intervention name: Virtual Reality
description: Child will wear and interact with virtual reality headset while waiting for surgery.
arm group label: Virtual Reality Group
other name: KindVR
intervention type: Drug
intervention name: Midazolam
description: Child will receive Midazolam to help with pre-operative anxiety prior to surgery
arm group label: Midazolam Group
other name: Versed
criteria: 
gender: All
minimum age: 5 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vanessa Pohl, B.S.
phone: 602-933-4482
email: vpohl@phoenixchildrens.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
PMID: 19272275
citation: Wiederhold BK, Gao K, Sulea C, Wiederhold MD. Virtual reality as a distraction technique in chronic pain patients. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):346-52. doi: 10.1089/cyber.2014.0207.
PMID: 24892196
citation: Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
PMID: 16882820
citation: Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
PMID: 8953995
citation: Wiederhold MD, Gao K, Wiederhold BK. Clinical use of virtual reality distraction system to reduce anxiety and pain in dental procedures. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):359-65. doi: 10.1089/cyber.2014.0203.
PMID: 24892198
citation: Mosso-Vazquez JL, Gao K, Wiederhold BK, Wiederhold MD. Virtual reality for pain management in cardiac surgery. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):371-8. doi: 10.1089/cyber.2014.0198.
PMID: 24892200
citation: Wiederhold BK, Soomro A, Riva G, Wiederhold MD. Future directions: advances and implications of virtual environments designed for pain management. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):414-22. doi: 10.1089/cyber.2014.0197.
PMID: 24892206
citation: Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.
PMID: 21264690
responsible party type: Principal Investigator
investigator affiliation: Valley Anesthesiology Consultants
investigator full name: Neil Raj Singhal
investigator title: Pain Management Research Director
mesh term: Midazolam
sharing ipd: No