<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/NCT03776344</url>
  </required_header>
  <id_info>
    <org_study_id>7150</org_study_id>
    <nct_id>NCT03776344</nct_id>
  </id_info>
  <brief_title>Virtual Reality for Post Operative Pain</brief_title>
  <acronym>VRppain</acronym>
  <official_title>Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Babes-Bolyai University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Babes-Bolyai 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>
      Randomized controlled trial to measure pain experience, side effects and satisfaction of VR&#xD;
      following varicose vein, hernia repair and gallbladder surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While there is substantial evidence supporting the use of Virtual Reality (VR) during&#xD;
      dressing changes for burn victims, there are little information of the effect of VR to&#xD;
      decrease pain after surgery. Although pharmacological analgesics are popular in clinical&#xD;
      practice, this approach usually is associated with side effects, most commonly nausea,&#xD;
      cognitive dysfunction, and constipation. Generally, VR effects are based on gate theory of&#xD;
      cognitive load, due to the fact that conscious attention is needed to perceive pain and we&#xD;
      can process a finite amount of information.High-Tech-VR devices shown to be more effective in&#xD;
      reducing pain than are Low-Tech-VR systems (Prothero, J. D., &amp; Hoffman, H. D, 1995). In&#xD;
      addition, studies have shown that interactivity play an important role to decrease both, pain&#xD;
      unpleasantness and time spent thinking about pain, while increasing fun (Wender, R., et al.,&#xD;
      2010, Gromala, D., et al 2011). Thus, interactivity helps patients to have a better immersion&#xD;
      into VR world. Considering this, in the proposed study, patients will be randomized to either&#xD;
      receive a high immersive and interactive VR environment using Oculus Rift Headset in addition&#xD;
      to standard care or to receive only standard care during their post-operative care following&#xD;
      surgery to prospectively assess the utility of virtual reality (VR) for pain management&#xD;
      following varicose vein, hernia repair and gallbladder surgeries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <phase>Phase 2</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>We tested the efficacy of a VR environment in the treatment of pain after surgery.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>As we had two groups in which one used a device for ensuring the masking the entire procedure was conducted in a separate room.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>Pain intensity before intervention; Change from Baseline pain intensity (immediately following intervention)</time_frame>
    <description>Graphic Rating Scale measure pain intensity from 1 to 10, 1 - no pain; 10 - worst pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>5 minutes before intervention (baseline)</time_frame>
    <description>Skin conductance response</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>15 minutes - During the intervention</time_frame>
    <description>Skin conductance response</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the intervention</measure>
    <time_frame>Immediately following intervention</time_frame>
    <description>Patient Satisfaction Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence in the VR environment</measure>
    <time_frame>Immediately following intervention</time_frame>
    <description>Presence Inventory assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simulator Sickness</measure>
    <time_frame>Immediately following intervention</time_frame>
    <description>Simulator Sickness Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relaxation</measure>
    <time_frame>Relaxation level before intervention; Change from Baseline relaxation level (immediately following intervention)</time_frame>
    <description>Graphic Rating Scale measure relaxation from 1 to 10, 1 - stressed; 10 - very relaxed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time thinking about pain</measure>
    <time_frame>immediately following intervention</time_frame>
    <description>Graphic Rating Scale measure the time spent thinking about pain from 1 to 10; 1 - not at all, 10 - all the time</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Virtual Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the experimental group will benefit from the usual standard care following surgery and during the second day the opportunity to use virtual reality for 15 minute. Along VR, they will complete the psychological and physiological measures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-VR condition (Standard of Care)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomized to the control group will benefit from the usual standard care following surgery and during the second day will complete the psychological and physiological measures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality intervention - Oculus Rift HD</intervention_name>
    <description>During the VR experience patients will have the opportunity to choose from different VR environments (VR application - Nature Treks VR) and explore them using Oculus Rift Device.</description>
    <arm_group_label>Virtual Reality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with varicose vein, hernia repair or gallbladder surgery&#xD;
&#xD;
          -  Patient in the acute care units, 1-3 days following surgery.&#xD;
&#xD;
          -  Willing and able to provide informed consent and participate in the study visit and&#xD;
             study follow-up questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-Romanian speaking patients.&#xD;
&#xD;
          -  Age &gt; 18 years and &lt; 65 years.&#xD;
&#xD;
          -  Patients with neoplastic pathologies.&#xD;
&#xD;
          -  Patients with history of motion sickness.&#xD;
&#xD;
          -  Patients with visual impairment.&#xD;
&#xD;
          -  Patients with severe/profound cognitive impairments measured with Six-item Cognitive&#xD;
             Impairment Test (6CIT).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Municipal Hospital of Cluj-Napoca</name>
      <address>
        <city>Cluj-Napoca</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Babes-Bolyai University</investigator_affiliation>
    <investigator_full_name>Raluca Georgescu</investigator_full_name>
    <investigator_title>Phd student</investigator_title>
  </responsible_party>
  <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>Yes</sharing_ipd>
    <ipd_description>All collected data will be shared in an anonymized manner.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After the manuscript will be published.</ipd_time_frame>
  </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/NCT03776344
org study id: 7150
nct id: NCT03776344
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomized controlled trial to measure pain experience, side effects and satisfaction of VR
      following varicose vein, hernia repair and gallbladder surgeries.
While there is substantial evidence supporting the use of Virtual Reality (VR) during
      dressing changes for burn victims, there are little information of the effect of VR to
      decrease pain after surgery. Although pharmacological analgesics are popular in clinical
      practice, this approach usually is associated with side effects, most commonly nausea,
      cognitive dysfunction, and constipation. Generally, VR effects are based on gate theory of
      cognitive load, due to the fact that conscious attention is needed to perceive pain and we
      can process a finite amount of information.High-Tech-VR devices shown to be more effective in
      reducing pain than are Low-Tech-VR systems (Prothero, J. D., & Hoffman, H. D, 1995). In
      addition, studies have shown that interactivity play an important role to decrease both, pain
      unpleasantness and time spent thinking about pain, while increasing fun (Wender, R., et al.,
      2010, Gromala, D., et al 2011). Thus, interactivity helps patients to have a better immersion
      into VR world. Considering this, in the proposed study, patients will be randomized to either
      receive a high immersive and interactive VR environment using Oculus Rift Headset in addition
      to standard care or to receive only standard care during their post-operative care following
      surgery to prospectively assess the utility of virtual reality (VR) for pain management
      following varicose vein, hernia repair and gallbladder surgeries.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: We tested the efficacy of a VR environment in the treatment of pain after surgery.
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: As we had two groups in which one used a device for ensuring the masking the entire procedure was conducted in a separate room.
measure: Pain intensity
time frame: Pain intensity before intervention; Change from Baseline pain intensity (immediately following intervention)
description: Graphic Rating Scale measure pain intensity from 1 to 10, 1 - no pain; 10 - worst pain.
measure: Pain intensity
time frame: 5 minutes before intervention (baseline)
description: Skin conductance response
measure: Pain intensity
time frame: 15 minutes - During the intervention
description: Skin conductance response
measure: Satisfaction with the intervention
time frame: Immediately following intervention
description: Patient Satisfaction Survey
measure: Presence in the VR environment
time frame: Immediately following intervention
description: Presence Inventory assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention
measure: Simulator Sickness
time frame: Immediately following intervention
description: Simulator Sickness Questionnaire
measure: Relaxation
time frame: Relaxation level before intervention; Change from Baseline relaxation level (immediately following intervention)
description: Graphic Rating Scale measure relaxation from 1 to 10, 1 - stressed; 10 - very relaxed.
measure: Time thinking about pain
time frame: immediately following intervention
description: Graphic Rating Scale measure the time spent thinking about pain from 1 to 10; 1 - not at all, 10 - all the time
arm group label: Virtual Reality
arm group type: Experimental
description: Patients randomized to the experimental group will benefit from the usual standard care following surgery and during the second day the opportunity to use virtual reality for 15 minute. Along VR, they will complete the psychological and physiological measures.
arm group label: Non-VR condition (Standard of Care)
arm group type: No Intervention
description: Patients randomized to the control group will benefit from the usual standard care following surgery and during the second day will complete the psychological and physiological measures.
intervention type: Device
intervention name: Virtual Reality intervention - Oculus Rift HD
description: During the VR experience patients will have the opportunity to choose from different VR environments (VR application - Nature Treks VR) and explore them using Oculus Rift Device.
arm group label: Virtual Reality
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Romania
responsible party type: Principal Investigator
investigator affiliation: Babes-Bolyai University
investigator full name: Raluca Georgescu
investigator title: Phd student
mesh term: Pain, Postoperative
sharing ipd: Yes
ipd description: All collected data will be shared in an anonymized manner.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After the manuscript will be published.