<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/NCT02995434</url>
  </required_header>
  <id_info>
    <org_study_id>H16-01510</org_study_id>
    <nct_id>NCT02995434</nct_id>
  </id_info>
  <brief_title>Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients</brief_title>
  <official_title>Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lotte &amp; John Hecht Memorial Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Simon Fraser University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fraser Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</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>
      This study seeks to explore the efficacy of immersive multimedia experiences as a practical&#xD;
      adjunctive therapeutic intervention in the self-management of the chronic pain associated&#xD;
      with cancer patients. A comparative controlled interventional trial and qualitative&#xD;
      interpretative-descriptive exploration will be undertaken with 100 cancer patients who are&#xD;
      experiencing chronic pain. Participants will be randomly assigned to either a virtual reality&#xD;
      (VR) therapy group or a 2D computer based multimedia control group (50 subjects in each).&#xD;
&#xD;
      They will undertake either a series of VR interventions, or 2D computer based multimedia&#xD;
      control sessions in their own homes over a period of a month. The intervention will be used&#xD;
      daily for a month to enable customization to the therapy and record data over a long enough&#xD;
      period of time to account for any individual short-term changes in pain.&#xD;
&#xD;
      The VR sessions will consist of using a VR head mounted display (HMD) and computer to explore&#xD;
      interactive immersive environments. The control group will be exposed to similar 2D computer&#xD;
      based multimedia experiences (without a VR headset) that on home computers. Pre, during, and&#xD;
      post pain test scores and quality of sleep assessments will be recorded using standardized&#xD;
      tools.&#xD;
&#xD;
      In addition to the primary study, a sub-study will be conducted where ten of the subjects who&#xD;
      demonstrated the most improvement in their pain using the VR experience will be selected and&#xD;
      invited to explore for any measurable changes in neurological activity using pre and post&#xD;
      exposure electroencephalography (EEG).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study seeks to explore the efficacy of an immersive multimedia experience as a practical&#xD;
      therapeutic intervention in the self-management of the chronic pain associated with cancer&#xD;
      patients.&#xD;
&#xD;
      This work will inform further clinical studies and future research into the potential uses of&#xD;
      immersive multimedia in the treatment of cancer associated pain. Furthermore, it will help&#xD;
      identify optimal immersive multimedia environments for use in chronic pain applications,&#xD;
      practical determinants for implementation of immersive multimedia for wider practice, and&#xD;
      will provide a better theoretical understanding of the mechanisms whereby immersive&#xD;
      multimedia works in chronic pain.&#xD;
&#xD;
      JUSTIFICATION&#xD;
&#xD;
      Cancer survivorship refers to individuals who have remained cancer free for a minimum of 5&#xD;
      years. Due to developments and greater outcomes associated with cancer therapy and&#xD;
      management, the number of individuals who survive cancer has risen considerably over the past&#xD;
      decade. Currently, 65% of adults and 80% of children can be expected to live at least 5 years&#xD;
      post cancer diagnosis. However, for some, survivorship is associated with debilitating&#xD;
      chronic pain which impacts negatively on quality of life. Reviews have suggested that up to&#xD;
      40% of individuals have survived cancer remain with cancer related chronic pain.&#xD;
&#xD;
      With rapidly emerging immersive multimedia technologies and clinical work in this field, it&#xD;
      would appear that immersive multimedia may have significant potential for use as an&#xD;
      adjunctive therapeutic measure for pain control. However, there has been little work done to&#xD;
      establish the potential use of immersive multimedia in the management of chronic cancer pain&#xD;
      to date, as most work on immersive multimedia for pain management has focused on acute pain&#xD;
      via distraction. Several researchers have recommended the investigation of immersive&#xD;
      multimedia for chronic, long term pain, and the research team completed a pilot study in 2015&#xD;
      to establish best methods and approaches for using immersive multimedia in chronic pain&#xD;
      conditions.&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
      To determine if immersive multimedia therapy is effective as an adjunctive intervention in&#xD;
      the management of chronic pain in cancer patients?&#xD;
&#xD;
        1. Can exposure to a immersive multimedia environment as an adjunctive pain-relieving&#xD;
           measure provide a pain-reducing experience for for chronic cancer pain patients?&#xD;
&#xD;
        2. How long (if at all) do any therapeutic effects of immersive multimedia last after&#xD;
           exposure in chronic cancer pain patients?&#xD;
&#xD;
        3. Are there any significant side effects of immersive multimedia exposure for chronic&#xD;
           cancer pain patients?&#xD;
&#xD;
        4. Do any identifiable neurological changes occur on EEG pre and post immersive multimedia&#xD;
           exposure?&#xD;
&#xD;
      RESEARCH METHODS&#xD;
&#xD;
      A longitudinal mixed-methods study to evaluate the impact of immersive multimedia for chronic&#xD;
      pain in cancer patients is proposed which will consist of a comparative controlled&#xD;
      interventional trial and qualitative interpretative-descriptive exploration.&#xD;
&#xD;
        1. Interventional Trial (Quantitative):&#xD;
&#xD;
           Participants will be randomly assigned to either a VR therapy group or the control group&#xD;
           (50 subjects in each). They will undertake either a series of immersive VR&#xD;
           interventions, or control sessions (using 2D multimedia on personal computers) in their&#xD;
           own homes over a period of a month.&#xD;
&#xD;
           To ensure the multi-dimensional aspects of chronic pain experienced by individuals are&#xD;
           measured adequately, pain assessment tools have been selected that will address&#xD;
           different aspects of each participant's' chronic pain and functional capacity. To&#xD;
           measure the impact of VR on each participant's pain intensity, the Visual Analog Scale&#xD;
           will be used during the VR and control experiences, pre and post exposure and at 10&#xD;
           minute intervals. In order to measure the change in pain during the therapy experience,&#xD;
           and overall sleep quality, at the end of each week, participants will also be asked to&#xD;
           complete post-intervention questionnaires: Health Survey (Short-Form 12), McGill Pain&#xD;
           Questionnaire, the Pittsburgh Sleep Quality Index, and also a brief Virtual Reality&#xD;
           Immersion Tool (to assess how immersive they found the experience that week).&#xD;
&#xD;
        2. Interpretive Description Study (Qualitative):&#xD;
&#xD;
      A Qualitative Interpretative-Descriptive exploration will be undertaken alongside the trial&#xD;
      to allow for a more open exploration of participants experiences and to further understanding&#xD;
      of the perceptions associated with the use of immersive multimedia and any impact upon their&#xD;
      chronic pain. An interpretative description (ID) approach will be used for this aspect of the&#xD;
      study. This methodology allows for an inductive descriptive analysis of the phenomena, and&#xD;
      was chosen as it is ideal for small scale studies, allowing for generation of themes,&#xD;
      patterns and theory associated with the patient's experience.&#xD;
&#xD;
      Following the completion of the clinical trial all participants will be sent an exploratory&#xD;
      questionnaire to discover their perceptions of immersive multimedia and its value (if any) in&#xD;
      the control of their chronic pain. In this questionnaire they will also be invited to&#xD;
      participate in one of two focus group interviews. Data from this will be analyzed and used to&#xD;
      support purposeful sampling of individuals to take part in the following focus-group&#xD;
      interviews, to include those subjects with a range of diverse opinions and ideas. As themes&#xD;
      and categories emerge from the data the researchers will seek to adapt the focus-group&#xD;
      interview sample with the purpose of strengthening the emerging theory and patterns by&#xD;
      including individuals who will help further define the characteristics of these themes and&#xD;
      categories.&#xD;
&#xD;
      Data Analysis&#xD;
&#xD;
      Quantitative Data: Descriptive and inferential statistical analysis will be performed on the&#xD;
      pain scores. For face-value quantitative indicators of potential effects univariate&#xD;
      descriptive statistics will be employed. Data will be analyzed for central tendency,&#xD;
      dispersion (standard deviation, interquartile range), skewness and kurtosis using SPSS&#xD;
      statistical analysis software to establish distribution and variance. Likewise, quantitative&#xD;
      data from the questionnaires will be analysed in this fashion. Data will be explored for&#xD;
      differences in the pain scales for the VR group and the control group at each time point to&#xD;
      analyze for any indications of changes immediately following the experience using Linear&#xD;
      Mixed Effects Modelling using SPSS software.&#xD;
&#xD;
      Qualitative Data: The focus-group interviews will be audiotaped. The questionnaire open text&#xD;
      results and transcriptions of focus groups will be recorded into NVivo 11.0 qualitative data&#xD;
      analysis software and read, re-read and coded for thematic elements by the PIs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Visual Analog Score for Pain</measure>
    <time_frame>Right before VR session and right after VR session</time_frame>
    <description>Use of the visual analog score for pain experience. Subjects will be asked about their pain intensity prior to the start of the VR session and asked for their pain intensity right after each VR session (recall for during the VR session and post VR session)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuronal Activity through EEG waveforms</measure>
    <time_frame>Before and after 30mins of VR session</time_frame>
    <description>Observe change in neuronal activity in the brain before and after a 30min VR session using EEG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>McGill Pain Questionnaire</measure>
    <time_frame>Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks</time_frame>
    <description>The McGill Pain Questionnaire is used to monitor the pain over time for participants in the study for any significant changes in pain during the intervention over the 4 weeks interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over the 4 weeks interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 Item Short Form Health Survey (SF-12)</measure>
    <time_frame>Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks</time_frame>
    <description>The SF-12 is used to assess the impact of health on an individual's everyday life over the 4 weeks interval.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Experience of using VR</measure>
    <time_frame>One month after VR session</time_frame>
    <description>A questionnaire as well as a focus group interview will be conducted one month after participants' VR session. Questions will focus on their experience of using VR (i.e., positives for using VR, negatives for using VR, would they use this therapy or not in the future etc.)</description>
  </other_outcome>
  <other_outcome>
    <measure>Immersion/Presence Questionnaire</measure>
    <time_frame>After using each environment for a week.</time_frame>
    <description>A questionnaire will be conducted for each environment the participant uses during the 4-week interval. Questions will focus on the whether the participant found the environment to be immersive, whether they felt 'present' in the experience, and additional comments on the sound, visual, and overall feelings about the environment used of the week.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomly assigned to the intervention group (50 in total).The VR intervention will be identical for each participant and consist of a PC running the immersive virtual reality application with a Virtual Reality headset 110 degrees field of view head mounted display. The VR will be a set of commercial exploratory virtual environment games designed for the HTC Vive headset. The intervention will be used for one month to enable customization to the therapy and record data over a long enough period of time to account for individual short- term changes in pain experience. Participants will be asked to use the VR therapy every day with a time exposure of 30 minutes for four consecutive weeks. There will be one rest day a week (normally a Sunday) where no therapy is given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will be exposed to 2D PC equivalent versions of the same multimedia experiences but on their PC screen (without the Virtual Reality headset use). These will be functionally similar to the VR experiences.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality Headset</intervention_name>
    <description>The following VR experiences will be used:&#xD;
Virtual Meditative Walk: http://painstudieslab.com/projects/virtual-meditative-walk/ Wildflowers: https://appadvice.com/app/wildflowers-mindfulness/988835763 Obduction: http://obduction.com/ Carpe Lucem: http://store.steampowered.com/app/433700/Carpe_Lucem__Seize_The_Light_VR/</description>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>HTC Vive</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>2D PC</intervention_name>
    <description>The control group will be exposed to 2D equivalent versions of the same multimedia experiences but on their PC screen (without the VR headset use). These will be functionally similar to the VR experiences. These will include:&#xD;
Virtual Meditative Walk: http://painstudieslab.com/projects/virtual-meditative-walk/ Wildflowers: https://appadvice.com/app/wildflowers-mindfulness/988835763 Obduction: http://obduction.com/ The Witness: http://store.steampowered.com/app/210970/</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 16 or older&#xD;
&#xD;
          -  Previous or current medical diagnosis of cancer&#xD;
&#xD;
          -  Previous or current treatment by chemotherapy, radiotherapy, hormonal&#xD;
&#xD;
          -  Currently an outpatient (not hospitalized)&#xD;
&#xD;
          -  Chronic pain sufferer (suffering ongoing daily pain for 3 months or more with a&#xD;
             Neuropathic Rating Pain Scale score of 4 or more)&#xD;
&#xD;
          -  Able to understand the English language, and read and write English&#xD;
&#xD;
          -  Have normal stereoscopic (binocular) vision&#xD;
&#xD;
          -  Able to easily move your head up, down, left and right and wear a headset&#xD;
&#xD;
          -  Have fine motor control in one hand sufficient to operate a joystick/control&#xD;
&#xD;
          -  Have space at home for a computer and monitor equipment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment/inability to control a basic computer VR interface, or complete&#xD;
             questionnaires&#xD;
&#xD;
          -  Receiving regular non-pharmacological pain relieving adjunct therapies for the&#xD;
             management of chronic pain&#xD;
&#xD;
          -  Susceptibility to motion sickness/cyber-sickness&#xD;
&#xD;
          -  Susceptibility to claustrophobia (fear of confined places)&#xD;
&#xD;
          -  History of susceptibility to seizures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernard M Garrett, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia - School of Nursing</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Crystal Sun, MPH</last_name>
    <phone>6048227679</phone>
    <email>Crystal.Sun@ubc.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bernard M Garrett, Ph.D.</last_name>
    <phone>6048227679</phone>
    <email>Bernie.Garett@ubc.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Simon Fraser University - School of Interactive Arts and Technology</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3T 0A3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diane Gromala, Ph.D.</last_name>
      <email>gromala@sfu.ca</email>
    </contact>
    <investigator>
      <last_name>Diane Gromala, Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of British Columbia - School of Nursing</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 2B5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bernard Garrett, Ph.D.</last_name>
      <email>Bernie.Garrett@ubc.ca</email>
    </contact>
    <investigator>
      <last_name>Bernard M Garett, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>BC Cancer</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Phillipa Hawley</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>October 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Bernard Garrett</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Virtual Reality</keyword>
  <keyword>Cancer Survivorship</keyword>
  <keyword>Pain Management</keyword>
  <keyword>Cancer Pain Management</keyword>
  <keyword>Chronic Pain Management</keyword>
  <keyword>Adjunctive Pain Management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 25, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02995434
org study id: H16-01510
nct id: NCT02995434
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study seeks to explore the efficacy of immersive multimedia experiences as a practical
      adjunctive therapeutic intervention in the self-management of the chronic pain associated
      with cancer patients. A comparative controlled interventional trial and qualitative
      interpretative-descriptive exploration will be undertaken with 100 cancer patients who are
      experiencing chronic pain. Participants will be randomly assigned to either a virtual reality
      (VR) therapy group or a 2D computer based multimedia control group (50 subjects in each).

      They will undertake either a series of VR interventions, or 2D computer based multimedia
      control sessions in their own homes over a period of a month. The intervention will be used
      daily for a month to enable customization to the therapy and record data over a long enough
      period of time to account for any individual short-term changes in pain.

      The VR sessions will consist of using a VR head mounted display (HMD) and computer to explore
      interactive immersive environments. The control group will be exposed to similar 2D computer
      based multimedia experiences (without a VR headset) that on home computers. Pre, during, and
      post pain test scores and quality of sleep assessments will be recorded using standardized
      tools.

      In addition to the primary study, a sub-study will be conducted where ten of the subjects who
      demonstrated the most improvement in their pain using the VR experience will be selected and
      invited to explore for any measurable changes in neurological activity using pre and post
      exposure electroencephalography (EEG).
This study seeks to explore the efficacy of an immersive multimedia experience as a practical
      therapeutic intervention in the self-management of the chronic pain associated with cancer
      patients.

      This work will inform further clinical studies and future research into the potential uses of
      immersive multimedia in the treatment of cancer associated pain. Furthermore, it will help
      identify optimal immersive multimedia environments for use in chronic pain applications,
      practical determinants for implementation of immersive multimedia for wider practice, and
      will provide a better theoretical understanding of the mechanisms whereby immersive
      multimedia works in chronic pain.

      JUSTIFICATION

      Cancer survivorship refers to individuals who have remained cancer free for a minimum of 5
      years. Due to developments and greater outcomes associated with cancer therapy and
      management, the number of individuals who survive cancer has risen considerably over the past
      decade. Currently, 65% of adults and 80% of children can be expected to live at least 5 years
      post cancer diagnosis. However, for some, survivorship is associated with debilitating
      chronic pain which impacts negatively on quality of life. Reviews have suggested that up to
      40% of individuals have survived cancer remain with cancer related chronic pain.

      With rapidly emerging immersive multimedia technologies and clinical work in this field, it
      would appear that immersive multimedia may have significant potential for use as an
      adjunctive therapeutic measure for pain control. However, there has been little work done to
      establish the potential use of immersive multimedia in the management of chronic cancer pain
      to date, as most work on immersive multimedia for pain management has focused on acute pain
      via distraction. Several researchers have recommended the investigation of immersive
      multimedia for chronic, long term pain, and the research team completed a pilot study in 2015
      to establish best methods and approaches for using immersive multimedia in chronic pain
      conditions.

      OBJECTIVES

      To determine if immersive multimedia therapy is effective as an adjunctive intervention in
      the management of chronic pain in cancer patients?

        1. Can exposure to a immersive multimedia environment as an adjunctive pain-relieving
           measure provide a pain-reducing experience for for chronic cancer pain patients?

        2. How long (if at all) do any therapeutic effects of immersive multimedia last after
           exposure in chronic cancer pain patients?

        3. Are there any significant side effects of immersive multimedia exposure for chronic
           cancer pain patients?

        4. Do any identifiable neurological changes occur on EEG pre and post immersive multimedia
           exposure?

      RESEARCH METHODS

      A longitudinal mixed-methods study to evaluate the impact of immersive multimedia for chronic
      pain in cancer patients is proposed which will consist of a comparative controlled
      interventional trial and qualitative interpretative-descriptive exploration.

        1. Interventional Trial (Quantitative):

           Participants will be randomly assigned to either a VR therapy group or the control group
           (50 subjects in each). They will undertake either a series of immersive VR
           interventions, or control sessions (using 2D multimedia on personal computers) in their
           own homes over a period of a month.

           To ensure the multi-dimensional aspects of chronic pain experienced by individuals are
           measured adequately, pain assessment tools have been selected that will address
           different aspects of each participant's' chronic pain and functional capacity. To
           measure the impact of VR on each participant's pain intensity, the Visual Analog Scale
           will be used during the VR and control experiences, pre and post exposure and at 10
           minute intervals. In order to measure the change in pain during the therapy experience,
           and overall sleep quality, at the end of each week, participants will also be asked to
           complete post-intervention questionnaires: Health Survey (Short-Form 12), McGill Pain
           Questionnaire, the Pittsburgh Sleep Quality Index, and also a brief Virtual Reality
           Immersion Tool (to assess how immersive they found the experience that week).

        2. Interpretive Description Study (Qualitative):

      A Qualitative Interpretative-Descriptive exploration will be undertaken alongside the trial
      to allow for a more open exploration of participants experiences and to further understanding
      of the perceptions associated with the use of immersive multimedia and any impact upon their
      chronic pain. An interpretative description (ID) approach will be used for this aspect of the
      study. This methodology allows for an inductive descriptive analysis of the phenomena, and
      was chosen as it is ideal for small scale studies, allowing for generation of themes,
      patterns and theory associated with the patient's experience.

      Following the completion of the clinical trial all participants will be sent an exploratory
      questionnaire to discover their perceptions of immersive multimedia and its value (if any) in
      the control of their chronic pain. In this questionnaire they will also be invited to
      participate in one of two focus group interviews. Data from this will be analyzed and used to
      support purposeful sampling of individuals to take part in the following focus-group
      interviews, to include those subjects with a range of diverse opinions and ideas. As themes
      and categories emerge from the data the researchers will seek to adapt the focus-group
      interview sample with the purpose of strengthening the emerging theory and patterns by
      including individuals who will help further define the characteristics of these themes and
      categories.

      Data Analysis

      Quantitative Data: Descriptive and inferential statistical analysis will be performed on the
      pain scores. For face-value quantitative indicators of potential effects univariate
      descriptive statistics will be employed. Data will be analyzed for central tendency,
      dispersion (standard deviation, interquartile range), skewness and kurtosis using SPSS
      statistical analysis software to establish distribution and variance. Likewise, quantitative
      data from the questionnaires will be analysed in this fashion. Data will be explored for
      differences in the pain scales for the VR group and the control group at each time point to
      analyze for any indications of changes immediately following the experience using Linear
      Mixed Effects Modelling using SPSS software.

      Qualitative Data: The focus-group interviews will be audiotaped. The questionnaire open text
      results and transcriptions of focus groups will be recorded into NVivo 11.0 qualitative data
      analysis software and read, re-read and coded for thematic elements by the PIs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Change in Visual Analog Score for Pain
time frame: Right before VR session and right after VR session
description: Use of the visual analog score for pain experience. Subjects will be asked about their pain intensity prior to the start of the VR session and asked for their pain intensity right after each VR session (recall for during the VR session and post VR session)
measure: Neuronal Activity through EEG waveforms
time frame: Before and after 30mins of VR session
description: Observe change in neuronal activity in the brain before and after a 30min VR session using EEG.
measure: McGill Pain Questionnaire
time frame: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks
description: The McGill Pain Questionnaire is used to monitor the pain over time for participants in the study for any significant changes in pain during the intervention over the 4 weeks interval.
measure: Pittsburgh Sleep Quality Index
time frame: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks
description: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over the 4 weeks interval.
measure: 12 Item Short Form Health Survey (SF-12)
time frame: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks
description: The SF-12 is used to assess the impact of health on an individual's everyday life over the 4 weeks interval.
measure: Experience of using VR
time frame: One month after VR session
description: A questionnaire as well as a focus group interview will be conducted one month after participants' VR session. Questions will focus on their experience of using VR (i.e., positives for using VR, negatives for using VR, would they use this therapy or not in the future etc.)
measure: Immersion/Presence Questionnaire
time frame: After using each environment for a week.
description: A questionnaire will be conducted for each environment the participant uses during the 4-week interval. Questions will focus on the whether the participant found the environment to be immersive, whether they felt 'present' in the experience, and additional comments on the sound, visual, and overall feelings about the environment used of the week.
arm group label: Intervention Group
arm group type: Experimental
description: Participants will be randomly assigned to the intervention group (50 in total).The VR intervention will be identical for each participant and consist of a PC running the immersive virtual reality application with a Virtual Reality headset 110 degrees field of view head mounted display. The VR will be a set of commercial exploratory virtual environment games designed for the HTC Vive headset. The intervention will be used for one month to enable customization to the therapy and record data over a long enough period of time to account for individual short- term changes in pain experience. Participants will be asked to use the VR therapy every day with a time exposure of 30 minutes for four consecutive weeks. There will be one rest day a week (normally a Sunday) where no therapy is given.
arm group label: Control Group
arm group type: Active Comparator
description: The control group will be exposed to 2D PC equivalent versions of the same multimedia experiences but on their PC screen (without the Virtual Reality headset use). These will be functionally similar to the VR experiences.
intervention type: Device
intervention name: Virtual Reality Headset
description: The following VR experiences will be used:
Virtual Meditative Walk: http://painstudieslab.com/projects/virtual-meditative-walk/ Wildflowers: https://appadvice.com/app/wildflowers-mindfulness/988835763 Obduction: http://obduction.com/ Carpe Lucem: http://store.steampowered.com/app/433700/Carpe_Lucem__Seize_The_Light_VR/
arm group label: Intervention Group
other name: HTC Vive
intervention type: Other
intervention name: 2D PC
description: The control group will be exposed to 2D equivalent versions of the same multimedia experiences but on their PC screen (without the VR headset use). These will be functionally similar to the VR experiences. These will include:
Virtual Meditative Walk: http://painstudieslab.com/projects/virtual-meditative-walk/ Wildflowers: https://appadvice.com/app/wildflowers-mindfulness/988835763 Obduction: http://obduction.com/ The Witness: http://store.steampowered.com/app/210970/
arm group label: Control Group
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bernard M Garrett, Ph.D.
role: Principal Investigator
affiliation: University of British Columbia - School of Nursing
last name: Crystal Sun, MPH
phone: 6048227679
email: Crystal.Sun@ubc.ca
last name: Bernard M Garrett, Ph.D.
phone: 6048227679
email: Bernie.Garett@ubc.ca
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Bernard Garrett
investigator title: Associate Professor
mesh term: Chronic Pain
sharing ipd: Undecided
submitted: May 25, 2023