<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/NCT03832478</url>
  </required_header>
  <id_info>
    <org_study_id>46879</org_study_id>
    <nct_id>NCT03832478</nct_id>
  </id_info>
  <brief_title>Longitudinal Virtual Reality Use in Pediatric Surgical Procedures</brief_title>
  <official_title>Longitudinal Virtual Reality Use in Pediatric Surgical Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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>
      This study aims to investigate the use of virtual reality guided mindfulness meditation to&#xD;
      reduce the pre and post-operative anxiety and pain of pediatric surgical patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-procedural anxiety in pediatric patients has been previously shown to increase the&#xD;
      likelihood of family stressors, agitation, sleep disturbances, and negative behavioral&#xD;
      changes. Post-procedural pain has been shown to negatively impact future interactions with&#xD;
      healthcare personnel. The purpose of this study is to determine the feasibility of using&#xD;
      guided mindfulness meditation through a non-invasive device (virtual reality headset) to&#xD;
      manage pre-procedure anxiety and post-procedure anxiety and pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Technical difficulty with sending device home with patients&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective observational study</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Children's Fear Scale</measure>
    <time_frame>Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis)</time_frame>
    <description>The Children's Fear Scale (McMurty et al., 2011) is a self-report scale that uses cartoon depictions of faces to quantify on a 0-4 scale how scared a child is at the given moment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Faces Pain Scale</measure>
    <time_frame>Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis)</time_frame>
    <description>The Faces Pain Scale (Hicks et al., 2001) is a self-report scale that uses cartoon depictions of faces to quantify on a 0-10 scale how much pain a child is experiencing at the given moment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Anxiety Scale</measure>
    <time_frame>Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis)</time_frame>
    <description>A self-report question on a 1-5 scale will be asked to assess how much anxiety a child is experiencing at the given moment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient and Parent Satisfaction Surveys</measure>
    <time_frame>Satisfaction surveys will be administered at the time of study completion (when the patient has completed his/her surgical procedure and is ready for hospital discharge/or 30 days post-procedure, whichever occurs first)</time_frame>
    <description>Parents, and patients will be given self-report survey questions asking about their satisfaction with the technology, the patients' immersion with the technology, and desire for use in future procedures. Questions will be answered on a 1-5 scale .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician Satisfaction Surveys</measure>
    <time_frame>Satisfaction survey will be administered to physicians within 48 hours of procedure completion. Physicians may return surveys up to one month post-procedure.</time_frame>
    <description>Surgeons and anesthesiologists will be given self-report survey questions asking about their satisfaction with the technology, the patients' immersion with the technology, and desire for use in future procedures. Questions will be answered on a 1-5 scale .</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Anxiety</condition>
  <condition>Pain</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Virtual Reality Headset Given</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual Reality headset (Samsung Gear VR) with mindfulness meditation app is given for patient use prior to surgery date and for duration of postoperative stay.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality Headset Given</intervention_name>
    <description>Samsung Gear VR Headset with guided mindfulness meditation app</description>
    <arm_group_label>Virtual Reality Headset Given</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have parental consent if under 18 or 18 and older but unable to provide own consent&#xD;
&#xD;
          -  Can comprehend instructions in English language&#xD;
&#xD;
          -  Is undergoing surgical procedure requiring general anesthesia at Lucile Packard&#xD;
             Children's Hospital&#xD;
&#xD;
          -  Children that are normally healthy (ASA I) or have a mild systemic disease (ASA II,&#xD;
             III)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with significant cognitive impairment or developmental delays per parental&#xD;
             report or H&amp;P&#xD;
&#xD;
          -  Children with ASA IV (severe systemic disease that is a constant threat to life) or&#xD;
             ASA V (unstable patients not expected to survive &gt;24hours or without operation)&#xD;
&#xD;
          -  Children currently taking psychotropic mediations will be excluded from this study due&#xD;
             to the affect emotion modulation&#xD;
&#xD;
          -  Children with history of seizures related to photosensitivity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie D Chao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lucile Packard Children's Hospital</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Pediatric Surgery Clinic</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.</citation>
    <PMID>21779307</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>Zeidan F, Gordon NS, Merchant J, Goolkasian P. The effects of brief mindfulness meditation training on experimentally induced pain. J Pain. 2010 Mar;11(3):199-209. doi: 10.1016/j.jpain.2009.07.015. Epub 2009 Oct 22.</citation>
    <PMID>19853530</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>He HG, Zhu L, Chan SW, Liam JL, Li HC, Ko SS, Klainin-Yobas P, Wang W. Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a randomized controlled trial. J Adv Nurs. 2015 May;71(5):1032-43. doi: 10.1111/jan.12608. Epub 2015 Jan 6.</citation>
    <PMID>25561079</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>March 17, 2021</last_update_submitted>
  <last_update_submitted_qc>March 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Stephanie D. Chao</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery (Pediatric Surgery)</investigator_title>
  </responsible_party>
  <keyword>Virtual Reality</keyword>
  <keyword>Meditation</keyword>
  <keyword>Mindfulness Meditation</keyword>
  <keyword>Guided Mindfulness Meditation</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Pain</keyword>
  <keyword>Postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT03832478
org study id: 46879
nct id: NCT03832478
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the use of virtual reality guided mindfulness meditation to
      reduce the pre and post-operative anxiety and pain of pediatric surgical patients.
Pre-procedural anxiety in pediatric patients has been previously shown to increase the
      likelihood of family stressors, agitation, sleep disturbances, and negative behavioral
      changes. Post-procedural pain has been shown to negatively impact future interactions with
      healthcare personnel. The purpose of this study is to determine the feasibility of using
      guided mindfulness meditation through a non-invasive device (virtual reality headset) to
      manage pre-procedure anxiety and post-procedure anxiety and pain.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective observational study
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Change in Children's Fear Scale
time frame: Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis)
description: The Children's Fear Scale (McMurty et al., 2011) is a self-report scale that uses cartoon depictions of faces to quantify on a 0-4 scale how scared a child is at the given moment.
measure: Change in Faces Pain Scale
time frame: Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis)
description: The Faces Pain Scale (Hicks et al., 2001) is a self-report scale that uses cartoon depictions of faces to quantify on a 0-10 scale how much pain a child is experiencing at the given moment.
measure: Change in Anxiety Scale
time frame: Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis)
description: A self-report question on a 1-5 scale will be asked to assess how much anxiety a child is experiencing at the given moment.
measure: Patient and Parent Satisfaction Surveys
time frame: Satisfaction surveys will be administered at the time of study completion (when the patient has completed his/her surgical procedure and is ready for hospital discharge/or 30 days post-procedure, whichever occurs first)
description: Parents, and patients will be given self-report survey questions asking about their satisfaction with the technology, the patients' immersion with the technology, and desire for use in future procedures. Questions will be answered on a 1-5 scale .
measure: Clinician Satisfaction Surveys
time frame: Satisfaction survey will be administered to physicians within 48 hours of procedure completion. Physicians may return surveys up to one month post-procedure.
description: Surgeons and anesthesiologists will be given self-report survey questions asking about their satisfaction with the technology, the patients' immersion with the technology, and desire for use in future procedures. Questions will be answered on a 1-5 scale .
arm group label: Virtual Reality Headset Given
arm group type: Experimental
description: Virtual Reality headset (Samsung Gear VR) with mindfulness meditation app is given for patient use prior to surgery date and for duration of postoperative stay.
intervention type: Device
intervention name: Virtual Reality Headset Given
description: Samsung Gear VR Headset with guided mindfulness meditation app
arm group label: Virtual Reality Headset Given
criteria: 
gender: All
minimum age: 5 Years
maximum age: 25 Years
healthy volunteers: No
last name: Stephanie D Chao, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
facility: 
country: United States
citation: Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.
PMID: 21779307
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: Zeidan F, Gordon NS, Merchant J, Goolkasian P. The effects of brief mindfulness meditation training on experimentally induced pain. J Pain. 2010 Mar;11(3):199-209. doi: 10.1016/j.jpain.2009.07.015. Epub 2009 Oct 22.
PMID: 19853530
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: He HG, Zhu L, Chan SW, Liam JL, Li HC, Ko SS, Klainin-Yobas P, Wang W. Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a randomized controlled trial. J Adv Nurs. 2015 May;71(5):1032-43. doi: 10.1111/jan.12608. Epub 2015 Jan 6.
PMID: 25561079
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Stephanie D. Chao
investigator title: Assistant Professor of Surgery (Pediatric Surgery)
mesh term: Pain, Postoperative
sharing ipd: No