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Effects of Virtual Reality in Pediatric Burn Patients

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ClinicalTrials.gov Identifier: NCT05973162
Recruitment Status : Recruiting
First Posted : August 2, 2023
Last Update Posted : September 5, 2023
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Burns Elbows Pediatric ALL Other: Virtual Realty Training Other: Transverse friction massage (TFM) Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Virtual Reality as an Adjunctive to Transverse Friction Massage in Pediatric Burn Patients
Actual Study Start Date : August 30, 2023
Estimated Primary Completion Date : March 28, 2024
Estimated Study Completion Date : April 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Virtual Reality training
Virtual Reality + Conventional PT
 Other: Virtual Realty Training

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
Experimental: Transverse friction massage (TFM)
Transverse friction massage (TFM)+ Conventional PT
 Other: Transverse friction massage (TFM)

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


Outcome Measures
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Primary Outcome Measures :
  1. Mayo Elbow Performance Index [ Time Frame: 2 weeks ]

    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


Secondary Outcome Measures :
  1. Burn Specific Pain Anxiety Scale (BSPAS) [ Time Frame: 2 weeks ]
    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.

  2. Goniometer [ Time Frame: 2 weeks ]
    It is an instrument that measures the available range of motion at a joint.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willingly participated in the study.
  • Age group:6-18.
  • Gender: both Male and Female
  • Acute burn injuries of elbow region (grade 2)
  • Superficial wounds healing phase( 5-10) days
  • TBSA is less than 20%

Exclusion Criteria

  • Motion sickness
  • History of seizure activity
  • Burns on body region that impede use of VR equipment (ears, eyes, head)
  • Deep burn (Grade 3,4)
  • Fractures
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05973162


Contacts
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Contact: Kinza Anwar, MS-OMPT +92-3239735427 kinza.anwar@riphah.edu.pk

Locations
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Pakistan
Burn units of Rawalpindi/Islamabad (PIMS hospital, Max Health hospital) Recruiting
Islamabad, Punjab, Pakistan
Contact: KINZA ANWAR, MS-OMPT    +92-3239735427    kinza.anwar@riphah.edu.pk   
Contact: Lareb Sattar, MS-OMPT*         
Sub-Investigator: Lareb Sattar, MS-OMPT*         
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Kinza Anwar, MS-OMPT Riphah International University
More Information
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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT05973162    
Other Study ID Numbers: REC/01651 Lareb Sattar
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: September 5, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Riphah International University:
Virtual Reality
Pediatric burn patients,
transverse friction massage
Elbow burn injuries
Additional relevant MeSH terms:
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Burns
Wounds and Injuries