<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/NCT04414501</url>
  </required_header>
  <id_info>
    <org_study_id>5180036</org_study_id>
    <nct_id>NCT04414501</nct_id>
  </id_info>
  <brief_title>Comparison of Virtual Reality to Tablet-based Distraction in Children</brief_title>
  <official_title>A Comparison of Virtual Reality Headset and Touch Screen Tablet for Minimizing Anxiety During Separation From Caregiver and Induction of Anesthesia in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</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>
      The proposed study is a prospective randomized trial to be performed in pediatric patient's&#xD;
      ages 4 to 10 years undergoing surgical procedures requiring general anesthesia. The purpose&#xD;
      is to compare the effectiveness of interactive tablet devices vs. Virtual Reality headsets.&#xD;
      The primary outcome measure being patient anxiety at the time of separation. Other comparison&#xD;
      measures will include preoperative parent/caregiver anxiety, anesthesia mask acceptance&#xD;
      characteristics at the time of induction, and time to fully recover in the post-operative&#xD;
      period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After receiving IRB approval from our institution and consent from parents or guardians, ASA&#xD;
      I or II status children ages 4 - 10 presenting for surgery requiring general anesthesia were&#xD;
      recruited for this study. They were assigned to either tablet- or VR-based groups. At our&#xD;
      institution, tablet-based distraction is widely used and represents standard practice.&#xD;
      Children in this control group were given tablets in the preoperative holding area before&#xD;
      transport to the operating room. Content consisted of entertainment apps providing access to&#xD;
      music videos, movies and games targeting various age groups.&#xD;
&#xD;
      The study group was given a Virtual Reality Smartphone headset in the preoperative holding&#xD;
      area prior to transport to the operating room. This headset was chosen because of its low&#xD;
      cost and wide compatibility for a variety of smartphones. The content consisted of several VR&#xD;
      environments that the child/parent could choose from.&#xD;
&#xD;
      In both groups, the distraction with tablet or VR was continued throughout separation from&#xD;
      caregivers, transport to the operating room, placement of monitors and mask induction of&#xD;
      general anesthesia. Anxiety at time of separation was measured by the modified Yale&#xD;
      Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait&#xD;
      Anxiety Inventory for Adults (STAI). Mask acceptance at induction of anesthesia was&#xD;
      determined by using the Mask Acceptance Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2018</start_date>
  <completion_date type="Actual">April 2, 2020</completion_date>
  <primary_completion_date type="Actual">April 2, 2020</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient anxiety at the time of separation in children before surgical procedures</measure>
    <time_frame>Preoperative Period</time_frame>
    <description>We will compare modified Yale Preoperative Anxiety Scale (mYPAS) scores between the tablet based distraction group to those in virtual reality group. The mYPAS evaluates 27 items divided into 5 categories: activity, vocalization, emotional expressivity, state of arousal, and use of parent. The score ranges from 23 (low anxiety) to 100 (high anxiety).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>additional anxiety scoring techniques</measure>
    <time_frame>Preoperative period</time_frame>
    <description>Short State-Trait Anxiety Inventory for Adults (STAI). The STAI is a validated self-evaluation questionnaire measuring anxiety with scores ranging from 6 (not at all) to 24 (very much).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mask acceptance by the patient</measure>
    <time_frame>Intraoperative period</time_frame>
    <description>Mask Acceptance Scores</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Anxiety, Separation</condition>
  <arm_group>
    <arm_group_label>Tablet study group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Anxiety at separation from caregiver was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. Mask acceptance, a functional evaluation of stress at the time of induction, was determined using the Mask Acceptance Scale.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VR study group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Anxiety at separation from caregiver was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. Mask acceptance, a functional evaluation of stress at the time of induction, was determined using the Mask Acceptance Scale.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Separation Anxiety</intervention_name>
    <description>Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.</description>
    <arm_group_label>Tablet study group</arm_group_label>
    <arm_group_label>VR study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children 4-10 years of age&#xD;
&#xD;
          -  Undergoing procedure that requires general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergent procedure&#xD;
&#xD;
          -  ASA III-IV&#xD;
&#xD;
          -  Patients with facial skin lesions&#xD;
&#xD;
          -  Patients with significant history of motion sickness&#xD;
&#xD;
          -  Visually impaired patients&#xD;
&#xD;
          -  Patients unable to wear a virtual reality headset&#xD;
&#xD;
          -  Patients receiving pharmacological intervention to decrease preoperative anxiety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Ghazal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University Medical Center</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lee J, Lee J, Lim H, Son JS, Lee JR, Kim DC, Ko S. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1168-73. doi: 10.1213/ANE.0b013e31824fb469. Epub 2012 Sep 25.</citation>
    <PMID>23011563</PMID>
  </reference>
  <reference>
    <citation>Cuzzocrea F, Gugliandolo MC, Larcan R, Romeo C, Turiaco N, Dominici T. A psychological preoperative program: effects on anxiety and cooperative behaviors. Paediatr Anaesth. 2013 Feb;23(2):139-43. doi: 10.1111/pan.12100.</citation>
    <PMID>23289773</PMID>
  </reference>
  <reference>
    <citation>Esteve R, Marquina-Aponte V, Ramirez-Maestre C. Postoperative pain in children: association between anxiety sensitivity, pain catastrophizing, and female caregivers' responses to children's pain. J Pain. 2014 Feb;15(2):157-68.e1. doi: 10.1016/j.jpain.2013.10.007. Epub 2013 Oct 27.</citation>
    <PMID>24360639</PMID>
  </reference>
  <reference>
    <citation>Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.</citation>
    <PMID>24237879</PMID>
  </reference>
  <reference>
    <citation>Yang KS, Habib AS, Lu M, Branch MS, Muir H, Manberg P, Sigl JC, Gan TJ. A prospective evaluation of the incidence of adverse events in nurse-administered moderate sedation guided by sedation scores or Bispectral Index. Anesth Analg. 2014 Jul;119(1):43-48. doi: 10.1213/ANE.0b013e3182a125c3.</citation>
    <PMID>24413547</PMID>
  </reference>
  <reference>
    <citation>Weiss KE, Dahlquist LM, Wohlheiter K. The effects of interactive and passive distraction on cold pressor pain in preschool-aged children. J Pediatr Psychol. 2011 Aug;36(7):816-26. doi: 10.1093/jpepsy/jsq125. Epub 2011 Jan 29.</citation>
    <PMID>21278378</PMID>
  </reference>
  <reference>
    <citation>Wohlheiter KA, Dahlquist LM. Interactive versus passive distraction for acute pain management in young children: the role of selective attention and development. J Pediatr Psychol. 2013 Mar;38(2):202-12. doi: 10.1093/jpepsy/jss108. Epub 2012 Oct 23.</citation>
    <PMID>23092971</PMID>
  </reference>
  <reference>
    <citation>Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS Jr, Roth A, Rosenblatt A, Jesdale BM, Suresh S. Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Paediatr Anaesth. 2014 Dec;24(12):1217-23. doi: 10.1111/pan.12475. Epub 2014 Jul 17.</citation>
    <PMID>25040433</PMID>
  </reference>
  <reference>
    <citation>Won AS, Bailey J, Bailenson J, Tataru C, Yoon IA, Golianu B. Immersive Virtual Reality for Pediatric Pain. Children (Basel). 2017 Jun 23;4(7):52. doi: 10.3390/children4070052.</citation>
    <PMID>28644422</PMID>
  </reference>
  <reference>
    <citation>Ryu JH, Park SJ, Park JW, Kim JW, Yoo HJ, Kim TW, Hong JS, Han SH. Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. Br J Surg. 2017 Nov;104(12):1628-1633. doi: 10.1002/bjs.10684. Epub 2017 Oct 4.</citation>
    <PMID>28975600</PMID>
  </reference>
  <reference>
    <citation>Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a &quot;gold standard&quot;? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.</citation>
    <PMID>9322455</PMID>
  </reference>
  <reference>
    <citation>Cox RG, Nemish U, Ewen A, Crowe MJ. Evidence-based clinical update: does premedication with oral midazolam lead to improved behavioural outcomes in children? Can J Anaesth. 2006 Dec;53(12):1213-9. doi: 10.1007/BF03021583.</citation>
    <PMID>17142656</PMID>
  </reference>
  <reference>
    <citation>Spielberger CD, Vagg PR. Psychometric properties of the STAI: a reply to Ramanaiah, Franzen, and Schill. J Pers Assess. 1984 Feb;48(1):95-7. doi: 10.1207/s15327752jpa4801_16. No abstract available.</citation>
    <PMID>6707862</PMID>
  </reference>
  <reference>
    <citation>Kumari S, Agrawal N, Usha G, Talwar V, Gupta P. Comparison of Oral Clonidine, Oral Dexmedetomidine, and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Surgery. Anesth Essays Res. 2017 Jan-Mar;11(1):185-191. doi: 10.4103/0259-1162.194586.</citation>
    <PMID>28298782</PMID>
  </reference>
  <reference>
    <citation>Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.</citation>
    <PMID>15114210</PMID>
  </reference>
  <reference>
    <citation>Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.</citation>
    <PMID>24257388</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 23, 2019</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loma Linda University</investigator_affiliation>
    <investigator_full_name>Elizabeth Ghazal</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety, Separation</mesh_term>
  </condition_browse>
  <!-- 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/NCT04414501
org study id: 5180036
nct id: NCT04414501
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The proposed study is a prospective randomized trial to be performed in pediatric patient's
      ages 4 to 10 years undergoing surgical procedures requiring general anesthesia. The purpose
      is to compare the effectiveness of interactive tablet devices vs. Virtual Reality headsets.
      The primary outcome measure being patient anxiety at the time of separation. Other comparison
      measures will include preoperative parent/caregiver anxiety, anesthesia mask acceptance
      characteristics at the time of induction, and time to fully recover in the post-operative
      period.
After receiving IRB approval from our institution and consent from parents or guardians, ASA
      I or II status children ages 4 - 10 presenting for surgery requiring general anesthesia were
      recruited for this study. They were assigned to either tablet- or VR-based groups. At our
      institution, tablet-based distraction is widely used and represents standard practice.
      Children in this control group were given tablets in the preoperative holding area before
      transport to the operating room. Content consisted of entertainment apps providing access to
      music videos, movies and games targeting various age groups.

      The study group was given a Virtual Reality Smartphone headset in the preoperative holding
      area prior to transport to the operating room. This headset was chosen because of its low
      cost and wide compatibility for a variety of smartphones. The content consisted of several VR
      environments that the child/parent could choose from.

      In both groups, the distraction with tablet or VR was continued throughout separation from
      caregivers, transport to the operating room, placement of monitors and mask induction of
      general anesthesia. Anxiety at time of separation was measured by the modified Yale
      Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait
      Anxiety Inventory for Adults (STAI). Mask acceptance at induction of anesthesia was
      determined by using the Mask Acceptance Scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Patient anxiety at the time of separation in children before surgical procedures
time frame: Preoperative Period
description: We will compare modified Yale Preoperative Anxiety Scale (mYPAS) scores between the tablet based distraction group to those in virtual reality group. The mYPAS evaluates 27 items divided into 5 categories: activity, vocalization, emotional expressivity, state of arousal, and use of parent. The score ranges from 23 (low anxiety) to 100 (high anxiety).
measure: additional anxiety scoring techniques
time frame: Preoperative period
description: Short State-Trait Anxiety Inventory for Adults (STAI). The STAI is a validated self-evaluation questionnaire measuring anxiety with scores ranging from 6 (not at all) to 24 (very much).
measure: Mask acceptance by the patient
time frame: Intraoperative period
description: Mask Acceptance Scores
arm group label: Tablet study group
arm group type: Active Comparator
description: Anxiety at separation from caregiver was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. Mask acceptance, a functional evaluation of stress at the time of induction, was determined using the Mask Acceptance Scale.
arm group label: VR study group
arm group type: Active Comparator
description: Anxiety at separation from caregiver was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. Mask acceptance, a functional evaluation of stress at the time of induction, was determined using the Mask Acceptance Scale.
intervention type: Behavioral
intervention name: Separation Anxiety
description: Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.
arm group label: Tablet study group
arm group label: VR study group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 10 Years
healthy volunteers: No
last name: Elizabeth Ghazal, MD
role: Principal Investigator
affiliation: Loma Linda University
facility: 
country: United States
citation: Lee J, Lee J, Lim H, Son JS, Lee JR, Kim DC, Ko S. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1168-73. doi: 10.1213/ANE.0b013e31824fb469. Epub 2012 Sep 25.
PMID: 23011563
citation: Cuzzocrea F, Gugliandolo MC, Larcan R, Romeo C, Turiaco N, Dominici T. A psychological preoperative program: effects on anxiety and cooperative behaviors. Paediatr Anaesth. 2013 Feb;23(2):139-43. doi: 10.1111/pan.12100.
PMID: 23289773
citation: Esteve R, Marquina-Aponte V, Ramirez-Maestre C. Postoperative pain in children: association between anxiety sensitivity, pain catastrophizing, and female caregivers' responses to children's pain. J Pain. 2014 Feb;15(2):157-68.e1. doi: 10.1016/j.jpain.2013.10.007. Epub 2013 Oct 27.
PMID: 24360639
citation: Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.
PMID: 24237879
citation: Yang KS, Habib AS, Lu M, Branch MS, Muir H, Manberg P, Sigl JC, Gan TJ. A prospective evaluation of the incidence of adverse events in nurse-administered moderate sedation guided by sedation scores or Bispectral Index. Anesth Analg. 2014 Jul;119(1):43-48. doi: 10.1213/ANE.0b013e3182a125c3.
PMID: 24413547
citation: Weiss KE, Dahlquist LM, Wohlheiter K. The effects of interactive and passive distraction on cold pressor pain in preschool-aged children. J Pediatr Psychol. 2011 Aug;36(7):816-26. doi: 10.1093/jpepsy/jsq125. Epub 2011 Jan 29.
PMID: 21278378
citation: Wohlheiter KA, Dahlquist LM. Interactive versus passive distraction for acute pain management in young children: the role of selective attention and development. J Pediatr Psychol. 2013 Mar;38(2):202-12. doi: 10.1093/jpepsy/jss108. Epub 2012 Oct 23.
PMID: 23092971
citation: Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS Jr, Roth A, Rosenblatt A, Jesdale BM, Suresh S. Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Paediatr Anaesth. 2014 Dec;24(12):1217-23. doi: 10.1111/pan.12475. Epub 2014 Jul 17.
PMID: 25040433
citation: Won AS, Bailey J, Bailenson J, Tataru C, Yoon IA, Golianu B. Immersive Virtual Reality for Pediatric Pain. Children (Basel). 2017 Jun 23;4(7):52. doi: 10.3390/children4070052.
PMID: 28644422
citation: Ryu JH, Park SJ, Park JW, Kim JW, Yoo HJ, Kim TW, Hong JS, Han SH. Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. Br J Surg. 2017 Nov;104(12):1628-1633. doi: 10.1002/bjs.10684. Epub 2017 Oct 4.
PMID: 28975600
citation: Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
PMID: 9322455
citation: Cox RG, Nemish U, Ewen A, Crowe MJ. Evidence-based clinical update: does premedication with oral midazolam lead to improved behavioural outcomes in children? Can J Anaesth. 2006 Dec;53(12):1213-9. doi: 10.1007/BF03021583.
PMID: 17142656
citation: Spielberger CD, Vagg PR. Psychometric properties of the STAI: a reply to Ramanaiah, Franzen, and Schill. J Pers Assess. 1984 Feb;48(1):95-7. doi: 10.1207/s15327752jpa4801_16. No abstract available.
PMID: 6707862
citation: Kumari S, Agrawal N, Usha G, Talwar V, Gupta P. Comparison of Oral Clonidine, Oral Dexmedetomidine, and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Surgery. Anesth Essays Res. 2017 Jan-Mar;11(1):185-191. doi: 10.4103/0259-1162.194586.
PMID: 28298782
citation: Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
PMID: 15114210
citation: Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.
PMID: 24257388
responsible party type: Principal Investigator
investigator affiliation: Loma Linda University
investigator full name: Elizabeth Ghazal
investigator title: Associate Professor
mesh term: Anxiety, Separation