BurnNCT06160518

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

A study testing Virtual reality in people with Burn and Hydrotherapy, run by Matrouh University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 3 to 6 years
Conditions the study is for: Burn, Hydrotherapy
What is being tested?: Virtual reality
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 27 Jul 2023to 30 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

Are cognitive or visual impairment.
Received strong pain killer or sedative medication.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Matrouh university
Marsá Maţrūḩ

Other trials in Egypt

About this study

Official title: 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.

Conditions: Burn, Hydrotherapy
Being tested: Virtual reality
Keywords: Virtual Reality, Pain, Clinical Outcomes, Hydrotherapy, Children, Burn
Medical subject headings: Burns, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual realityBehavioural
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.

Study groups in NCT06160518
Study group	Role	What they receive
Control	No intervention	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.
Study group	Experimental	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. Receives: Behavioral: Virtual reality

What is being measured

The primary outcome is the main question the study is designed to answer.

Physiological parameters assessment sheet: respiratory rate
cycle per minure
Measured: • 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
Measured: • 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%
Measured: • 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
Measured: • 10 minutes before hydrotherapy session. .

Secondary outcomes (1)

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).
Measured: • 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 202330 Dec 2023

First posted7 Dec 2023
Study start27 Jul 2023
Primary completion25 Dec 2023
Study completion30 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for BurnStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06160518
Sponsor's protocol ID: 0517
Status last verified: Mar 2024
First submitted: 20 Sep 2023
Last updated: 12 Mar 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ali RR, Selim AO, Abdel Ghafar MA, Abdelraouf OR, Ali OI. Virtual reality as a pain distractor during physical rehabilitation in pediatric burns. Burns. 2022 Mar;48(2):303-308. doi: 10.1016/j.burns.2021.04.031. Epub 2021 May 5.
PubMed 34154898
Ang SP, Montuori M, Trimba Y, Maldari N, Patel D, Chen QC. Recent Applications of Virtual Reality for the Management of Pain in Burn and Pediatric Patients. Curr Pain Headache Rep. 2021 Jan 14;25(1):4. doi: 10.1007/s11916-020-00917-0.
PubMed 33443603
Centers for Disease Control and Prevention [CDC], (2019). WISQARS data visualization. Available at: https://wisqars-viz.cdc.gov:8006/lcd/home (Accessed on 1 August 2023)
D'Alessandro, L.N., Corrales, I.L., Klein, S., Kondo, D., & Stinson, J. (2022). Using virtual reality distraction during wound management: A brief case report in a patient with epidermolysis bullosa. Pediatric Pain Letter,24(1):1-7.
Dumoulin S, Bouchard S, Ellis J, Lavoie KL, Vezina MP, Charbonneau P, Tardif J, Hajjar A. A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department. Games Health J. 2019 Aug;8(4):285-293. doi: 10.1089/g4h.2018.0111. Epub 2019 May 24.
PubMed 31135178
Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
PubMed 31136330
Elrod J, Schiestl CM, Mohr C, Landolt MA. Incidence, severity and pattern of burns in children and adolescents: An epidemiological study among immigrant and Swiss patients in Switzerland. Burns. 2019 Aug;45(5):1231-1241. doi: 10.1016/j.burns.2019.02.009. Epub 2019 May 13.
PubMed 31097353
Garrido-Ardila EM, Santos-Dominguez M, Rodriguez-Mansilla J, Torres-Piles ST, Rodriguez-Dominguez MT, Gonzalez-Sanchez B, Jimenez-Palomares M. A Systematic Review of the Effectiveness of Virtual Reality-Based Interventions on Pain and Range of Joint Movement Associated with Burn Injuries. J Pers Med. 2022 Jul 31;12(8):1269. doi: 10.3390/jpm12081269.
PubMed 36013218
Gerceker GO, Bektas M, Aydinok Y, Oren H, Ellidokuz H, Olgun N. The effect of virtual reality on pain, fear, and anxiety during access of a port with huber needle in pediatric hematology-oncology patients: Randomized controlled trial. Eur J Oncol Nurs. 2021 Feb;50:101886. doi: 10.1016/j.ejon.2020.101886. Epub 2020 Dec 1.
PubMed 33321461
Hansen JK, Voss J, Ganatra H, Langner T, Chalise P, Stokes S, Bhavsar D, Kovac AL. Sedation and Analgesia During Pediatric Burn Dressing Change: A Survey of American Burn Association Centers. J Burn Care Res. 2019 Apr 26;40(3):287-293. doi: 10.1093/jbcr/irz023.
PubMed 30844056
Hoffman HG, Rodriguez RA, Gonzalez M, Bernardy M, Pena R, Beck W, Patterson DR, Meyer WJ 3rd. Immersive Virtual Reality as an Adjunctive Non-opioid Analgesic for Pre-dominantly Latin American Children With Large Severe Burn Wounds During Burn Wound Cleaning in the Intensive Care Unit: A Pilot Study. Front Hum Neurosci. 2019 Aug 8;13:262. doi: 10.3389/fnhum.2019.00262. eCollection 2019.
PubMed 31440148
Jeschke MG, van Baar ME, Choudhry MA, Chung KK, Gibran NS, Logsetty S. Burn injury. Nat Rev Dis Primers. 2020 Feb 13;6(1):11. doi: 10.1038/s41572-020-0145-5.
PubMed 32054846
Khadra C, Ballard A, Dery J, Paquin D, Fortin JS, Perreault I, Labbe DR, Hoffman HG, Bouchard S, LeMay S. Projector-based virtual reality dome environment for procedural pain and anxiety in young children with burn injuries: a pilot study. J Pain Res. 2018 Feb 14;11:343-353. doi: 10.2147/JPR.S151084. eCollection 2018.
PubMed 29491717
Khadra C, Ballard A, Paquin D, Cotes-Turpin C, Hoffman HG, Perreault I, Fortin JS, Bouchard S, Theroux J, Le May S. Effects of a projector-based hybrid virtual reality on pain in young children with burn injuries during hydrotherapy sessions: A within-subject randomized crossover trial. Burns. 2020 Nov;46(7):1571-1584. doi: 10.1016/j.burns.2020.04.006. Epub 2020 May 7.
PubMed 32389349
LoBiondo-Wood, G., Haber, J., & Titler, M. G. (2018). Evidence-based practice for nursing and healthcare quality improvement. Elsevier Health Sciences.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Burn trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Technology and Children's Health: Effect of Virtual Reality on Pain and Clinical Outcomes During Hydrotherapy for Children With Burn
ClinicalTrials.gov ID: NCT06160518
Acronym / sponsor ID: 0517
Conditions: Burn, Hydrotherapy
Keywords: Virtual Reality, Pain, Clinical Outcomes, Hydrotherapy, Children, Burn
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Matrouh UniversityUniversity, hospital or other
Study start: 27 Jul 2023 (actual)
Primary completion: 25 Dec 2023 (actual)
Study completion: 30 Dec 2023 (actual)
First posted: 7 Dec 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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

Arm	Type	Receives
Control	No intervention	–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.
Study group	Experimental	Behavioral: Virtual realityThe 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.

Who may qualify

Ages: 3 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (2 listed)

Are cognitive or visual impairment.
Received strong pain killer or sedative medication.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Virtual realityartificial 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.	Behavioural	Study group

Primary outcome

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
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
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%
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

1 secondary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Background: PubMed 34154898Ali RR, Selim AO, Abdel Ghafar MA, Abdelraouf OR, Ali OI. Virtual reality as a pain distractor during physical rehabilitation in pediatric burns. Burns. 2022 Mar;48(2):303-308. doi: 10.1016/j.burns.2021.04.031. Epub 2021 May 5.
Background: PubMed 33443603Ang SP, Montuori M, Trimba Y, Maldari N, Patel D, Chen QC. Recent Applications of Virtual Reality for the Management of Pain in Burn and Pediatric Patients. Curr Pain Headache Rep. 2021 Jan 14;25(1):4. doi: 10.1007/s11916-020-00917-0.
BackgroundCenters for Disease Control and Prevention [CDC], (2019). WISQARS data visualization. Available at: https://wisqars-viz.cdc.gov:8006/lcd/home (Accessed on 1 August 2023)
BackgroundD'Alessandro, L.N., Corrales, I.L., Klein, S., Kondo, D., & Stinson, J. (2022). Using virtual reality distraction during wound management: A brief case report in a patient with epidermolysis bullosa. Pediatric Pain Letter,24(1):1-7.
Background: PubMed 31135178Dumoulin S, Bouchard S, Ellis J, Lavoie KL, Vezina MP, Charbonneau P, Tardif J, Hajjar A. A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department. Games Health J. 2019 Aug;8(4):285-293. doi: 10.1089/g4h.2018.0111. Epub 2019 May 24.
Background: PubMed 31136330Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
Background: PubMed 31097353Elrod J, Schiestl CM, Mohr C, Landolt MA. Incidence, severity and pattern of burns in children and adolescents: An epidemiological study among immigrant and Swiss patients in Switzerland. Burns. 2019 Aug;45(5):1231-1241. doi: 10.1016/j.burns.2019.02.009. Epub 2019 May 13.
Background: PubMed 36013218Garrido-Ardila EM, Santos-Dominguez M, Rodriguez-Mansilla J, Torres-Piles ST, Rodriguez-Dominguez MT, Gonzalez-Sanchez B, Jimenez-Palomares M. A Systematic Review of the Effectiveness of Virtual Reality-Based Interventions on Pain and Range of Joint Movement Associated with Burn Injuries. J Pers Med. 2022 Jul 31;12(8):1269. doi: 10.3390/jpm12081269.
Background: PubMed 33321461Gerceker GO, Bektas M, Aydinok Y, Oren H, Ellidokuz H, Olgun N. The effect of virtual reality on pain, fear, and anxiety during access of a port with huber needle in pediatric hematology-oncology patients: Randomized controlled trial. Eur J Oncol Nurs. 2021 Feb;50:101886. doi: 10.1016/j.ejon.2020.101886. Epub 2020 Dec 1.
Background: PubMed 30844056Hansen JK, Voss J, Ganatra H, Langner T, Chalise P, Stokes S, Bhavsar D, Kovac AL. Sedation and Analgesia During Pediatric Burn Dressing Change: A Survey of American Burn Association Centers. J Burn Care Res. 2019 Apr 26;40(3):287-293. doi: 10.1093/jbcr/irz023.
Background: PubMed 31440148Hoffman HG, Rodriguez RA, Gonzalez M, Bernardy M, Pena R, Beck W, Patterson DR, Meyer WJ 3rd. Immersive Virtual Reality as an Adjunctive Non-opioid Analgesic for Pre-dominantly Latin American Children With Large Severe Burn Wounds During Burn Wound Cleaning in the Intensive Care Unit: A Pilot Study. Front Hum Neurosci. 2019 Aug 8;13:262. doi: 10.3389/fnhum.2019.00262. eCollection 2019.
Background: PubMed 32054846Jeschke MG, van Baar ME, Choudhry MA, Chung KK, Gibran NS, Logsetty S. Burn injury. Nat Rev Dis Primers. 2020 Feb 13;6(1):11. doi: 10.1038/s41572-020-0145-5.
Individual participant dataSharing planned: No

Related trials for Burn

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Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality in people with Burn and Hydrotherapy, run by Matrouh University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06160518, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.