Clinical trial NCT06612892: Immersive Versus Passive Virtual Reality on Upper Limb Pain and Range of Motion in Pediatric Burn
Official title: Immersive Versus Passive Virtual Reality on Upper Limb Pain and Range of Motion in Pediatric Burn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Immersive Virtual Reality
Pediatric Burn
Passive Virtual Reality
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

1. Cardiac diseases.
2. Hand Burn
3. Exposed tendons.
4. Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases.
5. Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases.
6. Patients with facial burn.
7. 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).
8. Patients with visual or auditory disorders.
9. Patients with unstable fractures.
10. Central Nervous System (CNS) problems.
11. Patients with medical red flags as severe psychiatric disorder or cognitive deficits .
12. Medically unstable and uncooperative patients.

Primary outcomes:
measure: assessing the pain intensity using Colored Analog Scale (CAS)
timeFrame: at baseline and after 6 weeks
measure: assessing the range of motion using digital goniometer
timeFrame: at baseline and after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Haytham Mostafa Youssef
Study officials:
References: