Effects of Virtual Reality in Pediatric Burn Patients
Primary Purpose
Burns Elbows, Pediatric ALL
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Virtual Realty Training
Transverse friction massage (TFM)
Sponsored by
About this trial
This is an interventional treatment trial for Burns Elbows focused on measuring Virtual Reality, Pediatric burn patients,, transverse friction massage, Elbow burn injuries
Eligibility 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
Sites / Locations
- Burn units of Rawalpindi/Islamabad (PIMS hospital, Max Health hospital)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Virtual Reality training
Transverse friction massage (TFM)
Arm Description
Virtual Reality + Conventional PT
Transverse friction massage (TFM)+ Conventional PT
Outcomes
Primary Outcome Measures
Mayo Elbow Performance Index
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
Burn Specific Pain Anxiety Scale (BSPAS)
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.
Goniometer
It is an instrument that measures the available range of motion at a joint.
Full Information
NCT ID
NCT05973162
First Posted
July 25, 2023
Last Updated
August 31, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05973162
Brief Title
Effects of Virtual Reality in Pediatric Burn Patients
Official Title
Effects of Virtual Reality as an Adjunctive to Transverse Friction Massage in Pediatric Burn Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
March 28, 2024 (Anticipated)
Study Completion Date
April 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns Elbows, Pediatric ALL
Keywords
Virtual Reality, Pediatric burn patients,, transverse friction massage, Elbow burn injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality training
Arm Type
Active Comparator
Arm Description
Virtual Reality + Conventional PT
Arm Title
Transverse friction massage (TFM)
Arm Type
Experimental
Arm Description
Transverse friction massage (TFM)+ Conventional PT
Intervention Type
Other
Intervention Name(s)
Virtual Realty Training
Intervention 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
Intervention Type
Other
Intervention Name(s)
Transverse friction massage (TFM)
Intervention 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
Primary Outcome Measure Information:
Title
Mayo Elbow Performance Index
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
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Burn Specific Pain Anxiety Scale (BSPAS)
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.
Time Frame
2 weeks
Title
Goniometer
Description
It is an instrument that measures the available range of motion at a joint.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kinza Anwar, MS-OMPT
Phone
+92-3239735427
Email
kinza.anwar@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kinza Anwar, MS-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burn units of Rawalpindi/Islamabad (PIMS hospital, Max Health hospital)
City
Islamabad
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KINZA ANWAR, MS-OMPT
Phone
+92-3239735427
Email
kinza.anwar@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Lareb Sattar, MS-OMPT*
First Name & Middle Initial & Last Name & Degree
Lareb Sattar, MS-OMPT*
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Virtual Reality in Pediatric Burn Patients
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