<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/NCT04411264</url>
  </required_header>
  <id_info>
    <org_study_id>2019/CHU/12</org_study_id>
    <nct_id>NCT04411264</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds.</brief_title>
  <acronym>DouReV</acronym>
  <official_title>Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds: Multicentric Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de la Réunion</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de la Réunion</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>
      Pain management is a priority axis of health insurance spending objectives and contributes to&#xD;
      improving the quality of care.There are several types of pain: acute, chronic and induced.&#xD;
      These are often found in the management of chronic wounds. The high prevalence of chronic&#xD;
      wounds represents a major public health problem. Chronic wounds require long, painful and&#xD;
      regular treatment. When dressing these wounds, pain management is essential. Indeed, it can&#xD;
      generate healing delays. Usually, pharmacological methods are used to reduce the pain induced&#xD;
      by care. But these methods can lead to undesirable effects. Thus, new non-pharmacological&#xD;
      techniques are emerging.The investigators therefore wish to assess the effect of virtual&#xD;
      reality on pain induced by care during the repair of dressings in the management of chronic&#xD;
      wounds.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 1, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment-induced pain</measure>
    <time_frame>4 weeks</time_frame>
    <description>(AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of situational anxiety</measure>
    <time_frame>4 weeks</time_frame>
    <description>(STAI-Y-A) State-Trait Anxiety Scale - Overall score varies between 20 and 80. The higher the score, the more anxious the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of treatment</measure>
    <time_frame>4 weeks</time_frame>
    <description>time in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worse Treatment-induced pain</measure>
    <time_frame>4 weeks</time_frame>
    <description>Analog Visual Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of use of analgesic</measure>
    <time_frame>4 weeks</time_frame>
    <description>analgesic consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent thinking about pain</measure>
    <time_frame>4 weeks</time_frame>
    <description>(AVS) Analog Visual Scale 0 to 10 : 0 for no thought of pain ; 10 for throughout the treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healing process</measure>
    <time_frame>4 weeks</time_frame>
    <description>measurement of the wound on photograhies by imageJ ® planimetry software</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Outcome Study Short Form</measure>
    <time_frame>4 weeks</time_frame>
    <description>(SF6) Short Form (36) Health Survey_ Quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance of virtual reality</measure>
    <time_frame>4 weeks</time_frame>
    <description>frequency of occurrence and intensity of motion sickness events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Chronic Wounds</condition>
  <arm_group>
    <arm_group_label>Classic protocol for pain management</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>classic protocol for pain management during chronic wound dressing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual reality for pain management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>protocol associating virtual reality with the classic protocol for pain management during the treatment of chronic wound dressings</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>virtual reality</intervention_name>
    <description>Use of a virtual reality headset while caring for chronic wound dressings</description>
    <arm_group_label>Virtual reality for pain management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults&#xD;
&#xD;
          -  Knowing how to read and write French&#xD;
&#xD;
          -  Able to understand the issues of the study and give consent&#xD;
&#xD;
          -  Carrier of a chronic wound (ulcers, bedsores or wounds of the diabetic foot)&#xD;
&#xD;
          -  Requiring a weekly dressing treatment in the department for at least 4 successive&#xD;
             treatments(4 weeks)&#xD;
&#xD;
          -  With pain during pre-inclusion care at least ≥3 to the Visual Analog Scale&#xD;
&#xD;
          -  Person with cognitive and sensory capacities adapted to Virtual Reality (pre-inclusion&#xD;
             verification on a device test of 5 to 10 minutes)&#xD;
&#xD;
          -  Person affiliated or beneficiary of a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Carriers of a wound located on the face or end of the head and interfering with the&#xD;
             proper use of the Virtual Reality mask&#xD;
&#xD;
          -  Visually impaired and / or hard of hearing impacting the correct use of the Virtual&#xD;
             Reality mask (test of 5 to 10 minutes of the device during the pre-inclusion visit)&#xD;
&#xD;
          -  Patient not fluent in French.&#xD;
&#xD;
          -  Current diagnosis of epilepsy, dementia or other neurological diseases preventing the&#xD;
             use of Virtual Reality hardware and software&#xD;
&#xD;
          -  Patients under guardianship or curators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lucie AUZANNEAU</last_name>
    <phone>0262359949</phone>
    <phone_ext>+262</phone_ext>
    <email>lucie.auzanneau@chu-reunion.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Lucie AUZANNEAU</last_name>
    </contact>
    <investigator>
      <last_name>Camille DUPRAT, Nurse</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de la Réunion</name>
      <address>
        <city>Saint-Pierre</city>
        <zip>97410</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Lucie AUZANNEAU</last_name>
    </contact>
    <investigator>
      <last_name>Julien MAILLOT, Nurse</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT04411264
org study id: 2019/CHU/12
nct id: NCT04411264
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pain management is a priority axis of health insurance spending objectives and contributes to
      improving the quality of care.There are several types of pain: acute, chronic and induced.
      These are often found in the management of chronic wounds. The high prevalence of chronic
      wounds represents a major public health problem. Chronic wounds require long, painful and
      regular treatment. When dressing these wounds, pain management is essential. Indeed, it can
      generate healing delays. Usually, pharmacological methods are used to reduce the pain induced
      by care. But these methods can lead to undesirable effects. Thus, new non-pharmacological
      techniques are emerging.The investigators therefore wish to assess the effect of virtual
      reality on pain induced by care during the repair of dressings in the management of chronic
      wounds.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment-induced pain
time frame: 4 weeks
description: (AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable
measure: Level of situational anxiety
time frame: 4 weeks
description: (STAI-Y-A) State-Trait Anxiety Scale - Overall score varies between 20 and 80. The higher the score, the more anxious the patient.
measure: Duration of treatment
time frame: 4 weeks
description: time in seconds
measure: Worse Treatment-induced pain
time frame: 4 weeks
description: Analog Visual Scale
measure: Frequency of use of analgesic
time frame: 4 weeks
description: analgesic consumption
measure: Time spent thinking about pain
time frame: 4 weeks
description: (AVS) Analog Visual Scale 0 to 10 : 0 for no thought of pain ; 10 for throughout the treatment
measure: Healing process
time frame: 4 weeks
description: measurement of the wound on photograhies by imageJ ® planimetry software
measure: Medical Outcome Study Short Form
time frame: 4 weeks
description: (SF6) Short Form (36) Health Survey_ Quality of life questionnaire
measure: Tolerance of virtual reality
time frame: 4 weeks
description: frequency of occurrence and intensity of motion sickness events
arm group label: Classic protocol for pain management
arm group type: No Intervention
description: classic protocol for pain management during chronic wound dressing
arm group label: Virtual reality for pain management
arm group type: Experimental
description: protocol associating virtual reality with the classic protocol for pain management during the treatment of chronic wound dressings
intervention type: Device
intervention name: virtual reality
description: Use of a virtual reality headset while caring for chronic wound dressings
arm group label: Virtual reality for pain management
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lucie AUZANNEAU
phone: 0262359949
phone ext: +262
email: lucie.auzanneau@chu-reunion.fr
facility: 
contact: 
investigator: 
facility: 
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No