Effects of Virtual Reality in Pediatric Burn Patients

NCT ID: NCT05973162

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2024-04-28

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.

Conditions

Burns Elbows; Pediatric ALL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality training

Virtual Reality + Conventional PT

Group Type: ACTIVE_COMPARATOR

Virtual Realty Training

Intervention Type: OTHER

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

Transverse friction massage (TFM)

Transverse friction massage (TFM)+ Conventional PT

Group Type: EXPERIMENTAL

Transverse friction massage (TFM)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kinza Anwar, MS-OMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Burn units of Rawalpindi/Islamabad (PIMS hospital, Max Health hospital)

Islamabad, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Kinza Anwar, MS-OMPT

Role: CONTACT

kinza.anwar@riphah.edu.pk

+92-3239735427

Facility Contacts

KINZA ANWAR, MS-OMPT

Role: primary

kinza.anwar@riphah.edu.pk

+92-3239735427

Lareb Sattar, MS-OMPT*

Role: backup

Other Identifiers

REC/01651 Lareb Sattar

Identifier Type: -

Identifier Source: org_study_id