Virtual RealityNCT06612892
Immersive Versus Passive Virtual Reality on Upper Limb Pain and Range of Motion in Pediatric Burn
A study testing Virtual reality games in immersive VR modality, Virtual reality show in passive VR modality: and traditional physiotherapy in people with Virtual Reality and Immersive Virtual Reality, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the present study was to declare the difference between using immersive virtual reality vs passive virtual reality on pain management and improvement of ROM post physiotherapy exercise and mobilization sessions in pediatric burn patients. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Virtual Reality, Immersive Virtual Reality, Pediatric Burn
- What is being tested?
- Virtual reality games in immersive VR modality, Virtual reality show in passive VR modality: and traditional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2024to 10 Sep 2024
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Sixty patients have 2nd degree thermal burn injury, from both genders their ages will be ranged from 7 - 17 years old.
- They will be diagnosed by their physicians with 2nd degree thermal burn injury affecting upper limbs and referred for physical therapy management .
- TBSA calculated up to 9 for one upper limb.
- The patients will be in the acute stage post burn injury; the duration of burn will be 3 weeks post injury.
- Medically and psychologically stable patients
Who cannot join
- The potential participants will be excluded if they meet one of the following criteria:
- Cardiac diseases.
- Hand Burn
- Exposed tendons.
- Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases.
- Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases.
Show all 13Show fewer
- Patients with facial burn.
- Patients will have an inability to tolerate visual stimulation (e.g., susceptibility to migraines aggravated by light) or inability to tolerate the head mounted display (e.g., sensitivity to touch around the face and head).
- Patients with visual or auditory disorders.
- Patients with unstable fractures.
- Central Nervous System (CNS) problems.
- Patients with medical red flags as severe psychiatric disorder or cognitive deficits .
- Medically unstable and uncooperative patients.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the present study was to declare the difference between using immersive virtual reality vs passive virtual reality on pain management and improvement of ROM post physiotherapy exercise and mobilization sessions in pediatric burn patients.
Read the detailed description
Burn injuries are devastating and cause long-term damage to health. Thermal injuries, caused by hot liquids, solids, or fire, account for the majority of these injuries. Around 11 million burn cases occur annually worldwide. Rehabilitation aims to improve joint range od motion and control pain. Nonpharmocologic strategies like hypnosis and VR systems have shown promise in pain control. Multidisciplinary interventions from psychologists, physiotherapists, and pain management specialists can contribute to patient recovery. VR offers a holistic care device for pediatric burn patients.
- Being tested
- Virtual reality games in immersive VR modality, Virtual reality show in passive VR modality:, traditional physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality games in immersive VR modalityDevice
virtual reality involved three characters: a muscular boxer, a superhero, and a rock climber, with patients performing tasks in standing or sitting. Each experience takes 6 minutes, with 5-minute intervals between. Experimenters will instruct users on hand controls and virtual body observation.
Virtual reality show in passive VR modality:Device
In this modality the patient was asked to have a comfortable seat wearing the head set without holding the controllers , the therapist will play a relaxing show as a nature view or colorful scene as a sort of relaxation and mind distraction for around 20 minutes while asking the patient to perform upper limb muscle ROM exercise in active or active assisted form.
traditional physiotherapyOther
Includes stretching exercise for upper limb muscles affected by burn, scar tissue release , and splinting technique.
| Study group | Role | What they receive |
|---|---|---|
| Immersive virtual reality | Experimental | consisted of 30 patients and received procedure as immersive virtual reality program selected to enhance patient to use his upper limbs in order to interact with the show or game selected Receives: Device: Virtual reality games in immersive VR modality; Other: traditional physiotherapy |
| Passive virtual reality | Active comparator | consisted of 3o patients and received procedure as passive virtual reality program as the patient just wear the headset with a view or show meant only to distract pain while following therapist commands to do active or active assisted upper limbs ROM ex. Receives: Device: Virtual reality show in passive VR modality:; Other: traditional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing the pain intensity using Colored Analog Scale (CAS)
The Colored Analog Scale (CAS) is a thermometer-like tool that gradually darkens red as you progress, allowing children to indicate their pain levels with markers on the scale's back.
Measured: at baseline and after 6 weeks
assessing the range of motion using digital goniometer
The physical therapist will have to measure ROM before and after the intervention to monitor the improvement ,as the study focus on upper limb range of motion , following joints movement will be measured : shoulder flexion and abduction , elbow flexion and extension , wrist flexion and extension , forearm supination and pronation)
Measured: at baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start10 Mar 2024
- Primary completion10 Jun 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haytham Mostafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612892
- Sponsor's protocol ID
- Haitham-005156
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elsayed AGF, Mahmoud HMY, Eladl HM, Amer TA, Ali KM. Interactive versus passive virtual reality on upper limb pain, function, and range of motion in pediatric thermal burns, a randomized controlled trial. Burns. 2026 May;52(4):107920. doi: 10.1016/j.burns.2026.107920. Epub 2026 Feb 16.
PubMed 41775030
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Versus Passive Virtual Reality on Upper Limb Pain and Range of Motion in Pediatric Burn
- ClinicalTrials.gov ID
- NCT06612892
- Acronym / sponsor ID
- Haitham-005156
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 25 Sep 2024 (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.
The purpose of the present study was to declare the difference between using immersive virtual reality vs passive virtual reality on pain management and improvement of ROM post physiotherapy exercise and mobilization sessions in pediatric burn patients.
Detailed description
Burn injuries are devastating and cause long-term damage to health. Thermal injuries, caused by hot liquids, solids, or fire, account for the majority of these injuries. Around 11 million burn cases occur annually worldwide. Rehabilitation aims to improve joint range od motion and control pain. Nonpharmocologic strategies like hypnosis and VR systems have shown promise in pain control. Multidisciplinary interventions from psychologists, physiotherapists, and pain management specialists can contribute to patient recovery. VR offers a holistic care device for pediatric burn patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersive virtual reality | Experimental | Device: Virtual reality games in immersive VR modality, Other: traditional physiotherapyconsisted of 30 patients and received procedure as immersive virtual reality program selected to enhance patient to use his upper limbs in order to interact with the show or game selected |
| Passive virtual reality | Active comparator | Device: Virtual reality show in passive VR modality:, Other: traditional physiotherapyconsisted of 3o patients and received procedure as passive virtual reality program as the patient just wear the headset with a view or show meant only to distract pain while following therapist commands to do active or active assisted upper limbs ROM ex. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Sixty patients have 2nd degree thermal burn injury, from both genders their ages will be ranged from 7 - 17 years old.
- They will be diagnosed by their physicians with 2nd degree thermal burn injury affecting upper limbs and referred for physical therapy management .
- TBSA calculated up to 9 for one upper limb.
- The patients will be in the acute stage post burn injury; the duration of burn will be 3 weeks post injury.
- Medically and psychologically stable patients
Key exclusion criteria (13 listed)
- Cardiac diseases.
- Hand Burn
- Exposed tendons.
- Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases.
- Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases.
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 reality games in immersive VR modalityvirtual reality involved three characters: a muscular boxer, a superhero, and a rock climber, with patients performing tasks in standing or sitting. Each experience takes 6 minutes, with 5-minute intervals between. Experimenters will instruct users on hand controls and virtual body observation. | Device | Immersive virtual reality |
| Virtual reality show in passive VR modality:In this modality the patient was asked to have a comfortable seat wearing the head set without holding the controllers , the therapist will play a relaxing show as a nature view or colorful scene as a sort of relaxation and mind distraction for around 20 minutes while asking the patient to perform upper limb muscle ROM exercise in active or active assisted form. | Device | Passive virtual reality |
| traditional physiotherapyIncludes stretching exercise for upper limb muscles affected by burn, scar tissue release , and splinting technique. | Other | Immersive virtual reality, Passive virtual reality |
Primary outcome
assessing the pain intensity using Colored Analog Scale (CAS)
Time frame: at baseline and after 6 weeks
The Colored Analog Scale (CAS) is a thermometer-like tool that gradually darkens red as you progress, allowing children to indicate their pain levels with markers on the scale's back.
assessing the range of motion using digital goniometer
Time frame: at baseline and after 6 weeks
The physical therapist will have to measure ROM before and after the intervention to monitor the improvement ,as the study focus on upper limb range of motion , following joints movement will be measured : shoulder flexion and abduction , elbow flexion and extension , wrist flexion and extension , forearm supination and pronation)
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 25 Sep 2024.
- Derived from this study: PubMed 41775030Elsayed AGF, Mahmoud HMY, Eladl HM, Amer TA, Ali KM. Interactive versus passive virtual reality on upper limb pain, function, and range of motion in pediatric thermal burns, a randomized controlled trial. Burns. 2026 May;52(4):107920. doi: 10.1016/j.burns.2026.107920. Epub 2026 Feb 16.
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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 games in immersive VR modality, Virtual reality show in passive VR modality: and traditional physiotherapy in people with Virtual Reality and Immersive Virtual Reality, run by Cairo 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 13 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 25 Sep 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?
assessing the pain intensity using Colored Analog Scale (CAS) (time frame: at baseline and after 6 weeks). The study lists 2 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 NCT06612892, which also lists 1 linked publication.
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 25 Sep 2024.