<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/NCT02986555</url>
  </required_header>
  <id_info>
    <org_study_id>2016-10-007</org_study_id>
    <nct_id>NCT02986555</nct_id>
  </id_info>
  <brief_title>Research on Quantification of VR(Virtual Reality) Related Stress and Relaxation</brief_title>
  <official_title>Virtual Reality Stress and Relief Project, Research on Quantification of VR Related Stress, Motion Sickness and Visual Fatigue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Samsung Electronics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Current virtual reality device makes motion sickness and visual fatigue having limitation for&#xD;
      recreation and other clinical approaches. Still there is no standardized quantification of&#xD;
      motion sickness and visual fatigue measurement with objective approach. Current biofeedback&#xD;
      accompanied with virtual reality would be promising tool for stress relief.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current virtual reality device makes motion sickness and visual fatigue having limitation for&#xD;
      recreation and other clinical approaches. Still there is no standardized quantification of&#xD;
      motion sickness and visual fatigue measurement with objective approach. After quantification&#xD;
      and improvement with these shortcomings, current biofeedback accompanied with virtual reality&#xD;
      would be promising tool for stress relief. This research aims to measure objective motion&#xD;
      sickness and visual fatigue with psychological stress in highly stressed group, and to&#xD;
      compare between stress relief with existing biofeedback only approach and relief with mixed&#xD;
      biofeedback and virtual reality relaxation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Heart rate variability especially ratio of High Frequency and Low Frequency</measure>
    <time_frame>Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Respiration Rate</measure>
    <time_frame>Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological distress scale with Perceived Stress Scale 10</measure>
    <time_frame>Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale for motion sickness</measure>
    <time_frame>Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale for negative emotion</measure>
    <time_frame>Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale for visual fatigue</measure>
    <time_frame>Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Stress, Psychological</condition>
  <condition>Motion Sickness</condition>
  <condition>Visual Fatigue</condition>
  <arm_group>
    <arm_group_label>Stress relief with existing biofeedback</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After distressing virtual reality video and full resting time to relieve this stress, the investigators are going to give cognitive distress with serial seven, accompanied with existing biofeedback approach to relieve stress.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stress relief with biofeedback and VR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After distressing virtual reality video and full resting time to relieve this stress, the investigators are going to give cognitive distress with serial seven, accompanied with biofeedback combined to virtual reality relaxation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Existing Biofeedback</intervention_name>
    <description>Using relaxing assisted biofeedback approach</description>
    <arm_group_label>Stress relief with existing biofeedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biofeedback accompanied with virtual reality</intervention_name>
    <description>Using relaxation approach with existing biofeedback accompanied by virtual reality relaxation</description>
    <arm_group_label>Stress relief with biofeedback and VR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scored at least 20 on the PSS-10 (Perceived Stress Scale 10) to verify highly&#xD;
             psychological stressed participants at the baseline visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the existence of a current Major depressive disorder or panic disorder, psychotic&#xD;
             disorder (e.g., schizophrenia or delusional disorder), bipolar affective&#xD;
             disorder,active alcohol or drug use disorder, neurological illness including&#xD;
             significant cognitive impairment or Parkinson's disease, mental retardation,&#xD;
             significant medical conditions, epilepsy, histories of alcohol or drug dependence,&#xD;
             personality disorders, or brain damages during the screening and baseline visits, per&#xD;
             the Mini-International Neuropsychiatric Interview (Sheehan et al., 1998) according to&#xD;
             the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)&#xD;
&#xD;
          -  the existence of active disease in both orbital parts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Jin Jeon, M.D.,Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hong Jin Jeon, M.D.,Ph.D.</last_name>
    <phone>+82-2-3410-3586</phone>
    <email>jhj001001@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Irwon-dong, Gangnam-gu</state>
        <zip>135710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Jin Jeon, MD, PhD</last_name>
      <phone>82-10-3198-3586</phone>
      <email>jhj001001@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress</keyword>
  <keyword>Virtual Reality</keyword>
  <keyword>Motion sickness</keyword>
  <keyword>Visual Fatigue</keyword>
  <keyword>Biofeedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthenopia</mesh_term>
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Motion Sickness</mesh_term>
    <mesh_term>Stress, Psychological</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/NCT02986555
org study id: 2016-10-007
nct id: NCT02986555
lead sponsor: 
collaborator: 
has dmc: No
Current virtual reality device makes motion sickness and visual fatigue having limitation for
      recreation and other clinical approaches. Still there is no standardized quantification of
      motion sickness and visual fatigue measurement with objective approach. Current biofeedback
      accompanied with virtual reality would be promising tool for stress relief.
Current virtual reality device makes motion sickness and visual fatigue having limitation for
      recreation and other clinical approaches. Still there is no standardized quantification of
      motion sickness and visual fatigue measurement with objective approach. After quantification
      and improvement with these shortcomings, current biofeedback accompanied with virtual reality
      would be promising tool for stress relief. This research aims to measure objective motion
      sickness and visual fatigue with psychological stress in highly stressed group, and to
      compare between stress relief with existing biofeedback only approach and relief with mixed
      biofeedback and virtual reality relaxation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Change of Heart rate variability especially ratio of High Frequency and Low Frequency
time frame: Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)
measure: Change of Respiration Rate
time frame: Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)
measure: Psychological distress scale with Perceived Stress Scale 10
time frame: Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)
measure: Visual analogue scale for motion sickness
time frame: Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)
measure: Visual analogue scale for negative emotion
time frame: Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)
measure: Visual analogue scale for visual fatigue
time frame: Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)
arm group label: Stress relief with existing biofeedback
arm group type: Placebo Comparator
description: After distressing virtual reality video and full resting time to relieve this stress, the investigators are going to give cognitive distress with serial seven, accompanied with existing biofeedback approach to relieve stress.
arm group label: Stress relief with biofeedback and VR
arm group type: Active Comparator
description: After distressing virtual reality video and full resting time to relieve this stress, the investigators are going to give cognitive distress with serial seven, accompanied with biofeedback combined to virtual reality relaxation.
intervention type: Device
intervention name: Existing Biofeedback
description: Using relaxing assisted biofeedback approach
arm group label: Stress relief with existing biofeedback
intervention type: Device
intervention name: Biofeedback accompanied with virtual reality
description: Using relaxation approach with existing biofeedback accompanied by virtual reality relaxation
arm group label: Stress relief with biofeedback and VR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hong Jin Jeon, M.D.,Ph.D.
role: Principal Investigator
affiliation: Samsung Medical Center
last name: Hong Jin Jeon, M.D.,Ph.D.
phone: +82-2-3410-3586
email: jhj001001@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Asthenopia
mesh term: Fatigue
mesh term: Motion Sickness
mesh term: Stress, Psychological
sharing ipd: No