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Completed

NCT Number: NCT06612892

Immersive Versus Passive Virtual Reality on Upper Limb Pain and Range of Motion in Pediatric Burn

The purpose of the present study was to declare the difference between using immersive virtual reality vs passive virtual reality on pain management and improvement of ROM post physiotherapy exercise and mobilization sessions in pediatric burn patients.

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Key information

Conditions

Virtual Reality Immersive Virtual Reality Passive Virtual Reality Pediatric Burn

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haytham Mostafa Youssef

Cairo, Egypt

About this study

Burn injuries are devastating and cause long-term damage to health. Thermal injuries, caused by hot liquids, solids, or fire, account for the majority of these injuries. Around 11 million burn cases occur annually worldwide. Rehabilitation aims to improve joint range od motion and control pain. Nonpharmocologic strategies like hypnosis and VR systems have shown promise in pain control. Multidisciplinary interventions from psychologists, physiotherapists, and pain management specialists can contribute to patient recovery. VR offers a holistic care device for pediatric burn patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sixty patients have 2nd degree thermal burn injury, from both genders their ages will be ranged from 7 - 17 years old.
  • They will be diagnosed by their physicians with 2nd degree thermal burn injury affecting upper limbs and referred for physical therapy management .
  • TBSA calculated up to 9 for one upper limb.
  • The patients will be in the acute stage post burn injury; the duration of burn will be 3 weeks post injury.
  • Medically and psychologically stable patients

Exclusion criteria

The potential participants will be excluded if they meet one of the following criteria:

  • Cardiac diseases.
  • Hand Burn
  • Exposed tendons.
  • Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases.
  • Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases.
  • Patients with facial burn.
  • Patients will have an inability to tolerate visual stimulation (e.g., susceptibility to migraines aggravated by light) or inability to tolerate the head mounted display (e.g., sensitivity to touch around the face and head).
  • Patients with visual or auditory disorders.
  • Patients with unstable fractures.
  • Central Nervous System (CNS) problems.
  • Patients with medical red flags as severe psychiatric disorder or cognitive deficits .
  • Medically unstable and uncooperative patients.

Treatment and study plan

Virtual reality games in immersive VR modality

Device

virtual reality involved three characters: a muscular boxer, a superhero, and a rock climber, with patients performing tasks in standing or sitting. Each experience takes 6 minutes, with 5-minute intervals between. Experimenters will instruct users on hand controls and virtual body observation.

Virtual reality show in passive VR modality:

Device

In this modality the patient was asked to have a comfortable seat wearing the head set without holding the controllers , the therapist will play a relaxing show as a nature view or colorful scene as a sort of relaxation and mind distraction for around 20 minutes while asking the patient to perform upper limb muscle ROM exercise in active or active assisted form.

traditional physiotherapy

Other

Includes stretching exercise for upper limb muscles affected by burn, scar tissue release , and splinting technique.

Primary outcomes

  1. assessing the pain intensity using Colored Analog Scale (CAS)

    Time frame: at baseline and after 6 weeks

    The Colored Analog Scale (CAS) is a thermometer-like tool that gradually darkens red as you progress, allowing children to indicate their pain levels with markers on the scale's back.

  2. assessing the range of motion using digital goniometer

    Time frame: at baseline and after 6 weeks

    The physical therapist will have to measure ROM before and after the intervention to monitor the improvement ,as the study focus on upper limb range of motion , following joints movement will be measured : shoulder flexion and abduction , elbow flexion and extension , wrist flexion and extension , forearm supination and pronation)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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