NCT06160518 - Virtual Reality, Pain, Clinical Outcomes, Hydrotherapy, Children, Burn | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

60

Conditions

Burn Hydrotherapy

Interventions

Virtual realityBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

Matrouh university

Marsá Maţrūḩ, Egypt

Outcomes

Primary Outcomes

Physiological parameters assessment sheet: respiratory rate

cycle per minure

Time frame: • 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

Time frame: • 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%

Time frame: • 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

Time frame: • 10 minutes before hydrotherapy session. .

Secondary Outcomes

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).

Time frame: • 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.