Burn Clinical Trial
Official title:
Technology and Children's Health: Effect of Virtual Reality on Pain and Clinical Outcomes During Hydrotherapy for Children With Burn
NCT number | NCT06160518 |
Other study ID # | 0517 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 27, 2023 |
Est. completion date | December 30, 2023 |
Verified date | March 2024 |
Source | Matrouh University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate the effect of virtual reality on pain and clinical outcomes during hydrotherapy for children with burn.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 25, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Matrouh university | Mersa Matruh |
Lead Sponsor | Collaborator |
---|---|
Matrouh University |
Egypt,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | 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. |
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