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

March 10, 2024 updated by: Seham El-Sayed Saleh Hassan, Matrouh University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mersa Matruh, Egypt
        • Matrouh University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological parameters assessment sheet: respiratory rate
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.
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
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.
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.
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.
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.
Time Frame: • 10 minutes before hydrotherapy session. .
clinical data
• 10 minutes before hydrotherapy session. .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Assessment Scale
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 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matrouh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Actual)

December 25, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 10, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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