Virtual Reality, Pain, Clinical Outcomes, Hydrotherapy, Children, Burn

Study Overview
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Brief Summary
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This study aims to evaluate the effect of virtual reality on pain and clinical outcomes during hydrotherapy for children with burn.

Official Title
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Technology and Children's Health: Effect of Virtual Reality on Pain and Clinical Outcomes During Hydrotherapy for Children With Burn

Conditions
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Burn, Hydrotherapy

Intervention / Treatment
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* Behavioral: Virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 3-6 years. Children who do not have a burned face. Undergoing hydrotherapy procedure for wound care. Able to score their own pain, with or without a visual tool. Willing to participate in the study. Exclusion Criteria: Are cognitive or visual impairment. Received strong pain killer or sedative medication.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: virtual reality intervention which will take place using a cell phone coupled with the three-dimensional image glasses. The cell phone will play three-dimensional games which will be downloaded for free. The options for images and games involved which children could choose freely, all games will be suitable for the age group of the study. • The intervention will be applied for three days when hydrotherapy session done
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The children will receive the standard pharmacological treatment of the unit to manage pain and stabilize their physiological parameters throughout the three days of study. | |
| Experimental: Study group<br>The children will receive virtual reality intervention which will take place using a cell phone coupled with the three-dimensional image glasses. The cell phone will play three-dimensional games which will be downloaded for free. The options for images and games involved which children could choose freely, all games will be suitable for the age group of the study. | Behavioral: Virtual reality<br>* artificial construction of 3D environment via mobile technology. It included a head-mounted device (HMD) with 3D-enabled goggles, sensory input devices and headphones, which together allow a multisensory experience to divert a child's attention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological parameters assessment sheet: respiratory rate | cycle per minure | • 10 minutes before hydrotherapy session. • 5 minutes after hydrotherapy session started without VR. • 5 minutes after hydrotherapy session started using VR. • Immediately before hydrotherapy session VR. • 10 minutes after the hydrotherapy session. | 
| Physiological parameters assessment sheet heart rate | beat per minute | • 10 minutes before hydrotherapy session. • 5 minutes after hydrotherapy session started without VR. • 5 minutes after hydrotherapy session started using VR. • Immediately before hydrotherapy session VR. • 10 minutes after the hydrotherapy session. | 
| Physiological parameters assessment sheet:O2 saturation. | More than 95% | • 10 minutes before hydrotherapy session. • 5 minutes after hydrotherapy session started without VR. • 5 minutes after hydrotherapy session started using VR. • Immediately before hydrotherapy session VR. • 10 minutes after the hydrotherapy session. | 
| The clinical data assessment sheet:cause of burn, total body surface area burned, location of the burn, number of wounds, and the number of hydrotherapy sessions already undergoing. | clinical data | • 10 minutes before hydrotherapy session. . | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment Scale | The behavioral/observational pain scale that adopted from (Merkel et al, 1997) will be used in this study to evaluate the children's pain intensity using the FLACC categories. Each of the five categories (F)face, (L) Legs, (A) Activity, (C) Cry, (C) Consol ability, is scored 0-2, which result in total pain rating scale 0-10 (0 = no pain, relaxed and comfortable, 10 = severe pain/discomfort). | • 10 minutes before hydrotherapy session. • 5 minutes after hydrotherapy session started without VR. • 5 minutes after hydrotherapy session started using VR. • Immediately before hydrotherapy session VR. • 10 minutes after the hydrotherapy session. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrotherapy, Virtual Reality, Pain, Clinical Outcomes, Children, Burn