<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/NCT03799042</url>
  </required_header>
  <id_info>
    <org_study_id>CUHKHKT0818</org_study_id>
    <nct_id>NCT03799042</nct_id>
  </id_info>
  <brief_title>The Use of Virtual Reality (VR) and the Change in Emotion in Hong Kong Elders</brief_title>
  <official_title>The Use of Virtual Reality (VR) and the Change in Emotional State in Hong Kong Elders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</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>
      Virtual Reality (VR) is a technology that combines virtual technology and real-world&#xD;
      scenario. In recent years, more and more neuroscience and psychology scientists utilised VR&#xD;
      technology in their research. In Hong Kong, many of the community-dwelling elders are&#xD;
      immobile. Long-term homestay may negatively affect the emotional state. Measuring the&#xD;
      emotional change after administration of VR may prove it as an alternative tool for emotion&#xD;
      intervention.&#xD;
&#xD;
      The primary objective is to compare the improvement in the emotional changes between&#xD;
      intergeneration interaction and the use of VR technology.&#xD;
&#xD;
      The secondary objective is to evaluate the side effect after using VR technology.&#xD;
&#xD;
      This is a randomized, open label-controlled trial with a crossover design. The subject will&#xD;
      be randomized in a ratio of 1:1 into two different intervention groups, the VR group and the&#xD;
      Intergeneration Interaction group. After 2 weeks of washout period, the VR group will receive&#xD;
      Intergeneration Interaction and vice versa. The intervention phases last approximately 2&#xD;
      hours. The change in the emotional state will be assessed using the Positive and Negative&#xD;
      Affect Scale. Any adverse event that causes by the VR will be recorded using the Simulator&#xD;
      Sickness Questionnaire(SSQ).&#xD;
&#xD;
      This trial is the first study in Hong Kong to investigate the change of emotional state after&#xD;
      the administration of VR technology, targeting community-dwelling elders in Hong Kong.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positive and Negative Affect Schedule (PANAS)</measure>
    <time_frame>Major assessment points are scheduled prior to intervention(baseline), post intervention of the first visit (approximate 2 hours after baseline), and post intervention of the second visit (2 weeks after first intervention.)</time_frame>
    <description>Measure the difference in mean score between the two intervention groups. The Positive and Negative Affect Schedule (PANAS) is consist of 20 emotions. Positive Affect Score consists of 10 positive emotions, while Negative Affect Score consists of 10 negative emotions. Positive Affect Score ranges from 10 to 50, a score of 30 indicates a higher level of positive emotion. Negative Affect Score ranges from 10 to 50, a score of 15 indicates a higher level of negative emotion. Total PANAS score is 100, added up by both Positive Affect Score and Negative Affect Score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Simulator Sickness Questionnaire</measure>
    <time_frame>Major assessment points are scheduled prior to intervention(baseline), post intervention of the first visit (approximate 2 hours after baseline), and post intervention of the second visit (2 weeks after first intervention.)</time_frame>
    <description>Measure the difference in mean score between the two intervention groups. The Simulator Sickness Questionnaire (SSQ) is consist of 16 symptoms. Each symptom includes four level, none (0 marks), slight(1mark), moderate (2 marks) and severe(3). Three subscore are included, Nausea-related subscore (Symptom 1,6,7,8,9,15,16), Oculomotor-related subscore (Symptom 1,2,3,4,5,9,11), and Disorientation-related subscore (5,8,10,11,12,13,14). Adding Nausea subscore, oculomotor subscore, and disorientation subscore and multiply by 3.74. Total score larger than 15 indicated a significant level of adverse reaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Affect Schedule (PANAS)</measure>
    <time_frame>Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)</time_frame>
    <description>Measure the changes from baseline to first intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simulator Sickness Questionnaire</measure>
    <time_frame>Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)</time_frame>
    <description>Measure the changes from baseline to first intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">236</enrollment>
  <condition>Virtual Reality</condition>
  <condition>Emotions</condition>
  <arm_group>
    <arm_group_label>Vitural Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual Reality 3D glass</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inter-generation interaction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Elders-teenager interaction</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality</intervention_name>
    <description>Subjects will wear a 3D glass and watch 3D pictures (or video) of landscapes or tourist sites in Hong Kong.</description>
    <arm_group_label>Vitural Reality</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Inter-generation interaction</intervention_name>
    <description>Secondary school student will play games and chats with secondary school students. Games involve identifying famous landscapes or tourist sites in Hong Kong</description>
    <arm_group_label>Inter-generation interaction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Native Cantonese Speaker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelvin KF Tsoi, BSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Caritas Elderly Centre - Sai Kung</name>
      <address>
        <city>Hong Kong</city>
        <state>HK</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 10, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Kelvin KF Tsoi</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03799042
org study id: CUHKHKT0818
nct id: NCT03799042
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Virtual Reality (VR) is a technology that combines virtual technology and real-world
      scenario. In recent years, more and more neuroscience and psychology scientists utilised VR
      technology in their research. In Hong Kong, many of the community-dwelling elders are
      immobile. Long-term homestay may negatively affect the emotional state. Measuring the
      emotional change after administration of VR may prove it as an alternative tool for emotion
      intervention.

      The primary objective is to compare the improvement in the emotional changes between
      intergeneration interaction and the use of VR technology.

      The secondary objective is to evaluate the side effect after using VR technology.

      This is a randomized, open label-controlled trial with a crossover design. The subject will
      be randomized in a ratio of 1:1 into two different intervention groups, the VR group and the
      Intergeneration Interaction group. After 2 weeks of washout period, the VR group will receive
      Intergeneration Interaction and vice versa. The intervention phases last approximately 2
      hours. The change in the emotional state will be assessed using the Positive and Negative
      Affect Scale. Any adverse event that causes by the VR will be recorded using the Simulator
      Sickness Questionnaire(SSQ).

      This trial is the first study in Hong Kong to investigate the change of emotional state after
      the administration of VR technology, targeting community-dwelling elders in Hong Kong.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Positive and Negative Affect Schedule (PANAS)
time frame: Major assessment points are scheduled prior to intervention(baseline), post intervention of the first visit (approximate 2 hours after baseline), and post intervention of the second visit (2 weeks after first intervention.)
description: Measure the difference in mean score between the two intervention groups. The Positive and Negative Affect Schedule (PANAS) is consist of 20 emotions. Positive Affect Score consists of 10 positive emotions, while Negative Affect Score consists of 10 negative emotions. Positive Affect Score ranges from 10 to 50, a score of 30 indicates a higher level of positive emotion. Negative Affect Score ranges from 10 to 50, a score of 15 indicates a higher level of negative emotion. Total PANAS score is 100, added up by both Positive Affect Score and Negative Affect Score.
measure: Simulator Sickness Questionnaire
time frame: Major assessment points are scheduled prior to intervention(baseline), post intervention of the first visit (approximate 2 hours after baseline), and post intervention of the second visit (2 weeks after first intervention.)
description: Measure the difference in mean score between the two intervention groups. The Simulator Sickness Questionnaire (SSQ) is consist of 16 symptoms. Each symptom includes four level, none (0 marks), slight(1mark), moderate (2 marks) and severe(3). Three subscore are included, Nausea-related subscore (Symptom 1,6,7,8,9,15,16), Oculomotor-related subscore (Symptom 1,2,3,4,5,9,11), and Disorientation-related subscore (5,8,10,11,12,13,14). Adding Nausea subscore, oculomotor subscore, and disorientation subscore and multiply by 3.74. Total score larger than 15 indicated a significant level of adverse reaction.
measure: Positive and Negative Affect Schedule (PANAS)
time frame: Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)
description: Measure the changes from baseline to first intervention
measure: Simulator Sickness Questionnaire
time frame: Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)
description: Measure the changes from baseline to first intervention
arm group label: Vitural Reality
arm group type: Experimental
description: Virtual Reality 3D glass
arm group label: Inter-generation interaction
arm group type: Active Comparator
description: Elders-teenager interaction
intervention type: Device
intervention name: Virtual Reality
description: Subjects will wear a 3D glass and watch 3D pictures (or video) of landscapes or tourist sites in Hong Kong.
arm group label: Vitural Reality
intervention type: Behavioral
intervention name: Inter-generation interaction
description: Secondary school student will play games and chats with secondary school students. Games involve identifying famous landscapes or tourist sites in Hong Kong
arm group label: Inter-generation interaction
criteria: 
gender: All
minimum age: 50 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kelvin KF Tsoi, BSc, PhD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Kelvin KF Tsoi
investigator title: Associate Professor