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

Not Applicable

Completed

• Conditions: Burn; Hydrotherapy

• Registration Number: NCT06160518
• Lead Sponsor: Matrouh University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-27
• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-07
• Primary Completion: 2023-12-25
• Study Completion: 2023-12-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-10
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physiological parameters assessment sheet: respiratory rate	• 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.	cycle per minure
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.	• 10 minutes before hydrotherapy session. .	clinical data
Physiological parameters assessment sheet:O2 saturation.	• 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.	More than 95%
Physiological parameters assessment sheet heart rate	• 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.	beat per minute

Secondary Outcome Measures

Name	Time	Method
Pain Assessment Scale	• 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 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).

Trial Locations

Locations (1)

Matrouh university; 🇪🇬 Mersa Matruh, Egypt