BurnsNCT05352711
Virtual Reality on Pain and Range of Motion on Burn
A study testing active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con and active assisted range of motion exercise in people with Burns, run by Cairo University at 1 site in Egypt.
Trial summary
The Purpose of the study is to determine the effect of virtual reality exercise on pain and shoulder range of motion in pediatrics with 2nd-degree anterior shoulder burn injuries. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Burns
- What is being tested?
- active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con and active assisted range of motion exercise
- 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
- 20 Apr 2022to 30 Jun 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 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range between 9-16 years.
- Both sexes will participate in the study.
- Patients who suffered from anterior shoulder burns with involvement of axillary fold.
- patient who suffered from second degree burns.
- all patients are acute cases .
Who cannot join
- injuries to the face or head
- Injuries in hands
- Cognitive impairment
- A history of severe motion sickness
- Mental health problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality Exercise on Pain and Range of Motion in Pediatrics With Second Degree Anterior Shoulder Burn Injuries
The Purpose of the study is to determine the effect of virtual reality exercise on pain and shoulder range of motion in pediatrics with 2nd-degree anterior shoulder burn injuries.
Read the detailed description
Burns are an important cause of injury to young children, being the third most frequent cause of injury resulting in death behind motor vehicle accidents and drowning. Burn injuries account for the greatest length of stay of all hospital admissions for injuries and costs associated with care are substantial. The majority of burn injuries in children are scald injuries resulting from hot liquids, occurring most commonly in children aged 0-4 years. Other types of burns include electrical, chemical and intentional injury. Mechanisms of injury are often unique to children and involve exploratory behavior without the requisite comprehension of the dangers in their environment.
Immersive virtual reality (VR) is a new form of cognitive distraction and has been found to be an effective adjunctive, nonpharmacologic analgesic for postburn physical therapy. The VR gives the individual the illusion of "going into" the 3-dimensional computer generated environment, as if it were a place in which they are actually physically present. The strength of the presence is thought to reflect the amount of attention that is drawn into the virtual world. Because VR is a highly attention-grabbing experience, it can be an effective psychological pain control technique. Less attention to pain can result in reductions in pain intensity, unpleasantness, and the amount of time patients spend thinking about their pain.
- Conditions
- Burns
- Being tested
- active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con, active assisted range of motion exercise
- Keywords
- burn injuries
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand conDevice
VR is mainly created by generating visual effects through head-mounted display (HMD) systems. An HMD is a device worn on the head or as part of a helmet with a built-in display and lenses, allowing the user to experience the virtual world with the help of a wide viewing angle, head and hand movements tracking as well as objects interacting by controllers.
active assisted range of motion exerciseOther
Patients were treated active assisted ROM physical therapy 2 sessions per week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| active assisted exercise with Oculus Quest virtual reality (VR) group | Experimental | This group includes 30 patients suffered from pain and loss of shoulder flexion ROM, The patients will treated with active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand controller ) for 30 min. 2 times per week for 4 weeks The ROM will be assessed by mobile goniometer application and Smart phone version of visual analogue scale (VAS) to assess pain and The Quality-of-Life Scale for Children to assess the psychometric properties after the 1st session, day 14 and day 28. Receives: Device: active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con |
| active assisted range of motion exercise group | Active comparator | This group includes 30 patients suffering from pain and loss of shoulder flexion ROM. Patients will recieve active-assisted ROM physical therapy 2 sessions per week for 4 weeks. Receives: Other: active assisted range of motion exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
status of ROM for shoulder flexion assessment in day 1
mobile applications (apps) specifically designed to measure ROM
Measured: Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 1
change of ROM for shoulder flexion assessment in day 14
mobile applications (apps) specifically designed to measure ROM
Measured: Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 14
change of ROM for shoulder flexion assessment in day 28
mobile applications (apps) specifically designed to measure ROM
Measured: Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 28
status of shoulder pain assessment in day 1
Smart phone version of visual analogue scale (VAS) for assessing the pain ,the user touches the line, marking the location along the line that indicates the severity of the pain. An integer score between 0 and 100 is calculated based on the location of the marker relative to the ends of the line.(0 indicates no pain while 100 indicates worest pain)
Measured: evaluate psychometric properties within the distinct targeted samples in day 1
change of shoulder pain assessment in day 14
Smart phone version of visual analogue scale (VAS) for assessing the pain ,the user touches the line, marking the location along the line that indicates the severity of the pain. An integer score between 0 and 100 is calculated based on the location of the marker relative to the ends of the line.(0 indicates no pain while 100 indicates worest pain)
Measured: evaluate psychometric properties within the distinct targeted samples in day 14
change of shoulder pain assessment in day 28
Smart phone version of visual analogue scale (VAS) for assessing the pain ,the user touches the line, marking the location along the line that indicates the severity of the pain. An integer score between 0 and 100 is calculated based on the location of the marker relative to the ends of the line. (0 indicates no pain while 100 indicates worest pain)
Measured: evaluate psychometric properties within the distinct targeted samples in day 28
Secondary outcomes (2)
presentation of an individual's perception of their current health state
Quality-of-Life Scale from 0 to 10 (0 is the worst health you could imagine. 10 is the best health you could imagine)
Measured: questionnaire is used to asses the quality of patient's life at the first day of treatment
change in presentation of an individual's perception of their current health state
Quality-of-Life Scale from 0 to 10 (0 is the worst health you could imagine. 10 is the best health you could imagine)
Measured: this questionnaire will be used to asses the quality of patient's life at the day 28 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start20 Apr 2022
- Primary completion30 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Alaa Eid Abd-Elhafez, Cairo University
- Investigators
- Amal Mohamed Abd Albaky, Professor, Study chair, Vice dean of high education Faculty of Physical Therapy Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352711
- Sponsor's protocol ID
- P.T.REC/012/003467
- Status last verified
- Feb 2024
- First submitted
- 13 Apr 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Exercise on Pain and Range of Motion in Pediatrics With Second Degree Anterior Shoulder Burn Injuries
- ClinicalTrials.gov ID
- NCT05352711
- Acronym / sponsor ID
- P.T.REC/012/003467
- Conditions
- Burns
- Keywords
- burn injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Apr 2022 (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 study is to determine the effect of virtual reality exercise on pain and shoulder range of motion in pediatrics with 2nd-degree anterior shoulder burn injuries.
Detailed description
Burns are an important cause of injury to young children, being the third most frequent cause of injury resulting in death behind motor vehicle accidents and drowning. Burn injuries account for the greatest length of stay of all hospital admissions for injuries and costs associated with care are substantial. The majority of burn injuries in children are scald injuries resulting from hot liquids, occurring most commonly in children aged 0-4 years. Other types of burns include electrical, chemical and intentional injury. Mechanisms of injury are often unique to children and involve exploratory behavior without the requisite comprehension of the dangers in their environment.
Immersive virtual reality (VR) is a new form of cognitive distraction and has been found to be an effective adjunctive, nonpharmacologic analgesic for postburn physical therapy. The VR gives the individual the illusion of "going into" the 3-dimensional computer generated environment, as if it were a place in which they are actually physically present. The strength of the presence is thought to reflect the amount of attention that is drawn into the virtual world. Because VR is a highly attention-grabbing experience, it can be an effective psychological pain control technique. Less attention to pain can result in reductions in pain intensity, unpleasantness, and the amount of time patients spend thinking about their pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active assisted exercise with Oculus Quest virtual reality (VR) group | Experimental | Device: active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand conThis group includes 30 patients suffered from pain and loss of shoulder flexion ROM, The patients will treated with active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand controller ) for 30 min. 2 times per week for 4 weeks The ROM will be assessed by mobile goniometer application and Smart phone version of visual analogue scale (VAS) to assess pain and The Quality-of-Life Scale for Children to assess the psychometric properties after the 1st session, day 14 and day 28. |
| active assisted range of motion exercise group | Active comparator | Other: active assisted range of motion exerciseThis group includes 30 patients suffering from pain and loss of shoulder flexion ROM. Patients will recieve active-assisted ROM physical therapy 2 sessions per week for 4 weeks. |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age range between 9-16 years.
- Both sexes will participate in the study.
- Patients who suffered from anterior shoulder burns with involvement of axillary fold.
- patient who suffered from second degree burns.
- all patients are acute cases .
Key exclusion criteria (5 listed)
- injuries to the face or head
- Injuries in hands
- Cognitive impairment
- A history of severe motion sickness
- Mental health problems.
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 |
|---|---|---|
| active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand conVR is mainly created by generating visual effects through head-mounted display (HMD) systems. An HMD is a device worn on the head or as part of a helmet with a built-in display and lenses, allowing the user to experience the virtual world with the help of a wide viewing angle, head and hand movements tracking as well as objects interacting by controllers. | Device | active assisted exercise with Oculus Quest virtual reality (VR) group |
| active assisted range of motion exercisePatients were treated active assisted ROM physical therapy 2 sessions per week for 4 weeks. | Other | active assisted range of motion exercise group |
Primary outcome
status of ROM for shoulder flexion assessment in day 1
Time frame: Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 1
mobile applications (apps) specifically designed to measure ROM
change of ROM for shoulder flexion assessment in day 14
Time frame: Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 14
mobile applications (apps) specifically designed to measure ROM
change of ROM for shoulder flexion assessment in day 28
Time frame: Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 28
mobile applications (apps) specifically designed to measure ROM
status of shoulder pain assessment in day 1
Time frame: evaluate psychometric properties within the distinct targeted samples in day 1
Smart phone version of visual analogue scale (VAS) for assessing the pain ,the user touches the line, marking the location along the line that indicates the severity of the pain. An integer score between 0 and 100 is calculated based on the location of the marker relative to the ends of the line.(0 indicates no pain while 100 indicates worest pain)
change of shoulder pain assessment in day 14
Time frame: evaluate psychometric properties within the distinct targeted samples in day 14
Smart phone version of visual analogue scale (VAS) for assessing the pain ,the user touches the line, marking the location along the line that indicates the severity of the pain. An integer score between 0 and 100 is calculated based on the location of the marker relative to the ends of the line.(0 indicates no pain while 100 indicates worest pain)
change of shoulder pain assessment in day 28
Time frame: evaluate psychometric properties within the distinct targeted samples in day 28
Smart phone version of visual analogue scale (VAS) for assessing the pain ,the user touches the line, marking the location along the line that indicates the severity of the pain. An integer score between 0 and 100 is calculated based on the location of the marker relative to the ends of the line. (0 indicates no pain while 100 indicates worest pain)
2 secondary outcomes
presentation of an individual's perception of their current health state
Time frame: questionnaire is used to asses the quality of patient's life at the first day of treatment
change in presentation of an individual's perception of their current health state
Time frame: this questionnaire will be used to asses the quality of patient's life at the day 28 of treatment
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 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Amal Mohamed Abd Albaky, Professor study chair
Vice dean of high education Faculty of Physical Therapy Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con and active assisted range of motion exercise in people with Burns, 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 5 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 7 Feb 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?
status of ROM for shoulder flexion assessment in day 1 (time frame: Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2024.