<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/NCT04490603</url>
  </required_header>
  <id_info>
    <org_study_id>2005-086-1123</org_study_id>
    <nct_id>NCT04490603</nct_id>
  </id_info>
  <brief_title>The Effect of Virtual Reality Experience on Infusion-related Pain</brief_title>
  <official_title>The Effect of Virtual Reality Experience on Infusion-related Pain With Lumbar Epidural Catheterization: A Prospective, Randomized Comparative Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University</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 clinical trial aims to analyze the effect of virtual reality experience on&#xD;
      infusion-related pain with lumbar epidural catheterization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with chronic pain are to suffer from acute pain during their chronic pain-relieving&#xD;
      interventions. However, there is no active countermeasure against pain during these&#xD;
      procedures. This prospective randomized clinical study seeks to find an appropriate solution&#xD;
      to the procedure related acute pain of these patients by actively utilizing virtual reality&#xD;
      experiences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 19, 2020</start_date>
  <completion_date type="Anticipated">December 28, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 28, 2023</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>
    <intervention_model_description>Prospective randomized open-label clinical trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedure-related pain</measure>
    <time_frame>Right after the produre for 50 minutes ended.</time_frame>
    <description>Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with virtual reality experience</measure>
    <time_frame>Right after the produre for 50 minutes ended.</time_frame>
    <description>5-point Likert-like verbal rating scale: 1, extremely satisfied; 2, satisfied; 3, undecided; 4, dissatisfied; 5, extremely dissatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention-related wellness index-1 (IWI-1)</measure>
    <time_frame>Right after the produre for 50 minutes ended.</time_frame>
    <description>Drug injection-related pain (Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)) and patient satisfaction (satisfaction score) are calculated through principal component analysis as a new variable, IW index-1 (IWI-1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention-related wellness index-2 (IWI-2)</measure>
    <time_frame>Right after the produre for 50 minutes ended.</time_frame>
    <description>Calculated as IWI-2 by summing the procedure-related pain (Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)) and patient satisfaction (satisfaction score)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Virtual Reality</condition>
  <arm_group>
    <arm_group_label>Conventional group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Drug is injected to epidural space for a total of 50 minutes. The drug injection is provided in the same way as the conventional method of injecting drugs in Seoul National University Hospital Pain Center.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VR group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug is injected to epidural space for a total of 50 minutes. The drug injection is provided with virtual reality experience. Conditions are the same in both arms except for virtual reality experience.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual reality experience</intervention_name>
    <description>Patients are to experice virtual reality with virtual reality experience equipment (headsets, headphones, smartphones) and virtual reality experience programs. The equipments and programs are commercialized products on the market rather than medical products.</description>
    <arm_group_label>VR group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: If all of the following conditions are met&#xD;
&#xD;
          -  A person with chronic low back pain that lasts more than 3 months due to spinal&#xD;
             stenosis or lumbar disc disease.&#xD;
&#xD;
          -  Adults over 20&#xD;
&#xD;
          -  Those who decided to participate out of his/her own free will and signed in written&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria: If the patient meets one or more of the following criteria, He or She&#xD;
        cannot participate this clinical trial.&#xD;
&#xD;
          -  In case of contraindication to general lumbar catheterization (e.g. coatulopathy,&#xD;
             infection, etc)&#xD;
&#xD;
          -  Hearing and vision impairments&#xD;
&#xD;
          -  Affective disorder&#xD;
&#xD;
          -  History of epilepsy or seizure&#xD;
&#xD;
          -  If communication is not possible due to impaired cognitive ability&#xD;
&#xD;
          -  Those who have been deemed inappropriate by the researchers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jee Youn Moon, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jee Youn Moon, PhD</last_name>
    <phone>82-02-2072-2952</phone>
    <email>jymoon0901@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jee Youn Moon, M.D.</last_name>
      <phone>82-10-5299-2036</phone>
      <email>jymoon0901@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jee Youn Moon, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University</investigator_affiliation>
    <investigator_full_name>Jeeyoun Moon</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <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/NCT04490603
org study id: 2005-086-1123
nct id: NCT04490603
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical trial aims to analyze the effect of virtual reality experience on
      infusion-related pain with lumbar epidural catheterization.
Patients with chronic pain are to suffer from acute pain during their chronic pain-relieving
      interventions. However, there is no active countermeasure against pain during these
      procedures. This prospective randomized clinical study seeks to find an appropriate solution
      to the procedure related acute pain of these patients by actively utilizing virtual reality
      experiences.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective randomized open-label clinical trial
primary purpose: Supportive Care
masking: None (Open Label)
measure: Procedure-related pain
time frame: Right after the produre for 50 minutes ended.
description: Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)
measure: Patient satisfaction with virtual reality experience
time frame: Right after the produre for 50 minutes ended.
description: 5-point Likert-like verbal rating scale: 1, extremely satisfied; 2, satisfied; 3, undecided; 4, dissatisfied; 5, extremely dissatisfied
measure: Intervention-related wellness index-1 (IWI-1)
time frame: Right after the produre for 50 minutes ended.
description: Drug injection-related pain (Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)) and patient satisfaction (satisfaction score) are calculated through principal component analysis as a new variable, IW index-1 (IWI-1).
measure: Intervention-related wellness index-2 (IWI-2)
time frame: Right after the produre for 50 minutes ended.
description: Calculated as IWI-2 by summing the procedure-related pain (Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)) and patient satisfaction (satisfaction score)
arm group label: Conventional group
arm group type: No Intervention
description: Drug is injected to epidural space for a total of 50 minutes. The drug injection is provided in the same way as the conventional method of injecting drugs in Seoul National University Hospital Pain Center.
arm group label: VR group
arm group type: Experimental
description: Drug is injected to epidural space for a total of 50 minutes. The drug injection is provided with virtual reality experience. Conditions are the same in both arms except for virtual reality experience.
intervention type: Behavioral
intervention name: Virtual reality experience
description: Patients are to experice virtual reality with virtual reality experience equipment (headsets, headphones, smartphones) and virtual reality experience programs. The equipments and programs are commercialized products on the market rather than medical products.
arm group label: VR group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Jee Youn Moon, PhD
role: Study Director
affiliation: Associate Professor
last name: Jee Youn Moon, PhD
phone: 82-02-2072-2952
email: jymoon0901@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University
investigator full name: Jeeyoun Moon
investigator title: Associate professor
sharing ipd: No