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

NCT ID: NCT06612892

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-10
• Study Completion Date: 2024-09-10

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.

Conditions

Virtual Reality; Immersive Virtual Reality; Pediatric Burn; Passive Virtual Reality

Study Design

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

Study Groups

Immersive virtual reality

consisted of 30 patients and received procedure as immersive virtual reality program selected to enhance patient to use his upper limbs in order to interact with the show or game selected

Group Type: EXPERIMENTAL

Virtual reality games in immersive VR modality

Intervention Type: 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.

traditional physiotherapy

Intervention Type: OTHER

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

Passive virtual reality

consisted of 3o patients and received procedure as passive virtual reality program as the patient just wear the headset with a view or show meant only to distract pain while following therapist commands to do active or active assisted upper limbs ROM ex.

Group Type: ACTIVE_COMPARATOR

Virtual reality show in passive VR modality:

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

Virtual reality games in immersive VR modality

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.

Intervention Type: DEVICE

Virtual reality show in passive VR modality:

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.

Intervention Type: DEVICE

traditional physiotherapy

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Haytham Mostafa

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Haytham Mostafa Youssef

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Haitham-005156

Identifier Type: -

Identifier Source: org_study_id