Clinical trial NCT06160518: Virtual Reality, Pain, Clinical Outcomes, Hydrotherapy, Children, Burn
Official title: Technology and Children's Health: Effect of Virtual Reality on Pain and Clinical Outcomes During Hydrotherapy for Children With Burn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn
Hydrotherapy
Keywords: Virtual Reality
Pain
Clinical Outcomes
Hydrotherapy
Children
Burn
Lead sponsor: Matrouh University
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Physiological parameters assessment sheet: respiratory rate
timeFrame: • 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.
measure: Physiological parameters assessment sheet heart rate
timeFrame: • 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.
measure: Physiological parameters assessment sheet:O2 saturation.
timeFrame: • 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.
measure: 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.
timeFrame: • 10 minutes before hydrotherapy session. .
Secondary outcomes:
measure: Pain Assessment Scale
timeFrame: • 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.
Other outcomes:
Locations:
city: Mersa Matruh
country: Egypt
facility: Matrouh university
Study officials:
References:
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