xml: <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/NCT05973162</url>
    </required_header>
    <id_info>
      <org_study_id>REC/01651 Lareb Sattar</org_study_id>
      <nct_id>NCT05973162</nct_id>
    </id_info>
    <brief_title>Effects of Virtual Reality in Pediatric Burn Patients</brief_title>
    <official_title>Effects of Virtual Reality as an Adjunctive to Transverse Friction Massage in Pediatric Burn Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this randomized controlled trial is to find the effectiveness of Virtual reality&#xD;
        as an adjunctive to transverse friction massage in pediatric burn patients for reducing pain,&#xD;
        anxiety and enhancing elbow range of motion.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A burn injury is damage to the skin or other body parts caused by heat, chemicals,&#xD;
        electricity, radiation, or friction.Pain or discomfort, redness and swelling, blistering,&#xD;
        peeling skin, scarring , difficulty breathing, shock in cases of severe burn, fever as a&#xD;
        complication of burn, anxiety and depression are some main signs and symptoms after burn&#xD;
        injuries. Upper limb burn injuries are more common as compared to lower limb , trunk or head&#xD;
        and neck. Physical therapy plays an important role in reducing pain and improving range of&#xD;
        motion and prevention of contractures formation after burn injuries.&#xD;
  &#xD;
        Virtual Reality training (VR) uses a computer-generated simulation of a three-dimensional&#xD;
        environment that can be interacted with in a seemingly real or physical way. In the context&#xD;
        of burn injuries, VR can be used as a distraction technique during wound care procedures or&#xD;
        as an adjunct to pain management, and reduction of anxiety level.&#xD;
  &#xD;
        Transverse friction massage Therapy is a Cyriax technique , is applied by the fingers&#xD;
        directly to the lesion and transverse to the direction of fibers.Pressure is applied with the&#xD;
        ball of the practitioners thumb or fingers to the patient's skin or muscles. Friction massage&#xD;
        applied correctly will quickly result in analgesic effect over the treated area. Friction&#xD;
        prevents the adhesion formations as a result leads to improvement of range of motion ,&#xD;
        prevention of contractures formation as well as pain relief.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">April 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 28, 2024</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mayo Elbow Performance Index</measure>
      <time_frame>2 weeks</time_frame>
      <description>MEPI is an instrument used to test the limitations, caused by pathology, of the elbow during activities of daily living (ADL). This specific test uses 4 subscales:&#xD;
  Pain,&#xD;
  Range of Motion&#xD;
  Stability&#xD;
  Daily Function The clinical information is rated based on a 100 points scale.&#xD;
  &lt;60 - poor&#xD;
  60-74 - fair&#xD;
  75-89 - good&#xD;
  90-100 - excellent</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Burn Specific Pain Anxiety Scale (BSPAS)</measure>
      <time_frame>2 weeks</time_frame>
      <description>The BSPAS is a 9 item self report scale for the assessment of pain related and anticipatory anxiety in burn patients. The items are scored on a 100 mm visual analog line with two reference points given values of 0 and 100. The reference points are identified by these numbers, and also by the expressions 'not at all' and 'the worst imaginable way'. There is no middle ranged reference position or 'neutral' point on this visual analog line.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Goniometer</measure>
      <time_frame>2 weeks</time_frame>
      <description>It is an instrument that measures the available range of motion at a joint.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Burns Elbows</condition>
    <condition>Pediatric ALL</condition>
    <arm_group>
      <arm_group_label>Virtual Reality training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Virtual Reality + Conventional PT</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Transverse friction massage (TFM)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Transverse friction massage (TFM)+ Conventional PT</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Virtual Realty Training</intervention_name>
      <description>They would be receiving treatment as follow:&#xD;
  Virtual Reality is a technology that aims to completely immerse the user inside the computer generated world, giving the impression to the user that they have &quot;stepped inside&quot; the synthetic world. RA mobile phone , head mounted display (HMD) will be used and videos of patient's interest will be played on phone which will create a 3D world around the patient.&#xD;
  And while watching conventional physical therapy will be performed side by side.&#xD;
  Conventional PT including range of motion exercises of elbow region including flexion, extension, supination, pronation, stretching and strengthening exercises of elbow muscles. Frequency: 10 reps with 5 sec hold for 3 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins Type: Strengthening Exercises</description>
      <arm_group_label>Virtual Reality training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Transverse friction massage (TFM)</intervention_name>
      <description>They would be receiving treatment as follow:&#xD;
  Transverse friction massage (Soft tissue mobilization technique) on the surrounding burn region for 5-10min in intervals. Frequency: 3 times/week for 2 consecutive weeks. Intensity: moderate intensity (pain free) Time: 10 mins Conventional PT including range of motion exercises of elbow region including flexion, extension, supination, pronation, stretching and strengthening exercises of elbow muscles. Frequency: 10 reps with 5 sec hold for 3 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins Type: Strengthening Exercises</description>
      <arm_group_label>Transverse friction massage (TFM)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Willingly participated in the study.&#xD;
  &#xD;
            -  Age group:6-18.&#xD;
  &#xD;
            -  Gender: both Male and Female&#xD;
  &#xD;
            -  Acute burn injuries of elbow region (grade 2)&#xD;
  &#xD;
            -  Superficial wounds healing phase( 5-10) days&#xD;
  &#xD;
            -  TBSA is less than 20%&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            -  Motion sickness&#xD;
  &#xD;
            -  History of seizure activity&#xD;
  &#xD;
            -  Burns on body region that impede use of VR equipment (ears, eyes, head)&#xD;
  &#xD;
            -  Deep burn (Grade 3,4)&#xD;
  &#xD;
            -  Fractures&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kinza Anwar, MS-OMPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kinza Anwar, MS-OMPT</last_name>
      <phone>+92-3239735427</phone>
      <email>kinza.anwar@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Burn units of Rawalpindi/Islamabad (PIMS hospital, Max Health hospital)</name>
        <address>
          <city>Islamabad</city>
          <state>Punjab</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>KINZA ANWAR, MS-OMPT</last_name>
        <phone>+92-3239735427</phone>
        <email>kinza.anwar@riphah.edu.pk</email>
      </contact>
      <contact_backup>
        <last_name>Lareb Sattar, MS-OMPT*</last_name>
      </contact_backup>
      <investigator>
        <last_name>Lareb Sattar, MS-OMPT*</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Virtual Reality</keyword>
    <keyword>Pediatric burn patients,</keyword>
    <keyword>transverse friction massage</keyword>
    <keyword>Elbow burn injuries</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Burns</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973162
  org study id: REC/01651 Lareb Sattar
  nct id: NCT05973162
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  The aim of this randomized controlled trial is to find the effectiveness of Virtual reality
        as an adjunctive to transverse friction massage in pediatric burn patients for reducing pain,
        anxiety and enhancing elbow range of motion.
  A burn injury is damage to the skin or other body parts caused by heat, chemicals,
        electricity, radiation, or friction.Pain or discomfort, redness and swelling, blistering,
        peeling skin, scarring , difficulty breathing, shock in cases of severe burn, fever as a
        complication of burn, anxiety and depression are some main signs and symptoms after burn
        injuries. Upper limb burn injuries are more common as compared to lower limb , trunk or head
        and neck. Physical therapy plays an important role in reducing pain and improving range of
        motion and prevention of contractures formation after burn injuries.
  
        Virtual Reality training (VR) uses a computer-generated simulation of a three-dimensional
        environment that can be interacted with in a seemingly real or physical way. In the context
        of burn injuries, VR can be used as a distraction technique during wound care procedures or
        as an adjunct to pain management, and reduction of anxiety level.
  
        Transverse friction massage Therapy is a Cyriax technique , is applied by the fingers
        directly to the lesion and transverse to the direction of fibers.Pressure is applied with the
        ball of the practitioners thumb or fingers to the patient's skin or muscles. Friction massage
        applied correctly will quickly result in analgesic effect over the treated area. Friction
        prevents the adhesion formations as a result leads to improvement of range of motion ,
        prevention of contractures formation as well as pain relief.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Mayo Elbow Performance Index
  time frame: 2 weeks
  description: MEPI is an instrument used to test the limitations, caused by pathology, of the elbow during activities of daily living (ADL). This specific test uses 4 subscales:
  Pain,
  Range of Motion
  Stability
  Daily Function The clinical information is rated based on a 100 points scale.
  <60 - poor
  60-74 - fair
  75-89 - good
  90-100 - excellent
  measure: Burn Specific Pain Anxiety Scale (BSPAS)
  time frame: 2 weeks
  description: The BSPAS is a 9 item self report scale for the assessment of pain related and anticipatory anxiety in burn patients. The items are scored on a 100 mm visual analog line with two reference points given values of 0 and 100. The reference points are identified by these numbers, and also by the expressions 'not at all' and 'the worst imaginable way'. There is no middle ranged reference position or 'neutral' point on this visual analog line.
  measure: Goniometer
  time frame: 2 weeks
  description: It is an instrument that measures the available range of motion at a joint.
  arm group label: Virtual Reality training
  arm group type: Active Comparator
  description: Virtual Reality + Conventional PT
  arm group label: Transverse friction massage (TFM)
  arm group type: Experimental
  description: Transverse friction massage (TFM)+ Conventional PT
  intervention type: Other
  intervention name: Virtual Realty Training
  description: They would be receiving treatment as follow:
  Virtual Reality is a technology that aims to completely immerse the user inside the computer generated world, giving the impression to the user that they have "stepped inside" the synthetic world. RA mobile phone , head mounted display (HMD) will be used and videos of patient's interest will be played on phone which will create a 3D world around the patient.
  And while watching conventional physical therapy will be performed side by side.
  Conventional PT including range of motion exercises of elbow region including flexion, extension, supination, pronation, stretching and strengthening exercises of elbow muscles. Frequency: 10 reps with 5 sec hold for 3 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins Type: Strengthening Exercises
  arm group label: Virtual Reality training
  intervention type: Other
  intervention name: Transverse friction massage (TFM)
  description: They would be receiving treatment as follow:
  Transverse friction massage (Soft tissue mobilization technique) on the surrounding burn region for 5-10min in intervals. Frequency: 3 times/week for 2 consecutive weeks. Intensity: moderate intensity (pain free) Time: 10 mins Conventional PT including range of motion exercises of elbow region including flexion, extension, supination, pronation, stretching and strengthening exercises of elbow muscles. Frequency: 10 reps with 5 sec hold for 3 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins Type: Strengthening Exercises
  arm group label: Transverse friction massage (TFM)
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Kinza Anwar, MS-OMPT
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Kinza Anwar, MS-OMPT
  phone: +92-3239735427
  email: kinza.anwar@riphah.edu.pk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Burns
  sharing ipd: No