Burns ElbowsNCT05973162
Effects of Virtual Reality in Pediatric Burn Patients
A study testing Virtual Realty Training and Transverse friction massage (TFM) in people with Burns Elbows and Pediatric ALL, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this randomized controlled trial is to find the effectiveness of Virtual reality as an adjunctive to transverse friction massage in pediatric burn patients for reducing pain, anxiety and enhancing elbow range of motion. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Burns Elbows, Pediatric ALL
- What is being tested?
- Virtual Realty Training and Transverse friction massage (TFM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2023to 28 Apr 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Willingly participated in the study.
- Age group:6-18.
- Gender: both Male and Female
- Acute burn injuries of elbow region (grade 2)
- Superficial wounds healing phase( 5-10) days
- TBSA is less than 20%
Who cannot join
- Motion sickness
- History of seizure activity
- Burns on body region that impede use of VR equipment (ears, eyes, head)
- Deep burn (Grade 3,4)
- Fractures
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Burn units of Rawalpindi/Islamabad (PIMS hospital, Max Health hospital)
Islamabad, Punjab Province
KINZA ANWAR, MS-OMPT, +92-3239735427, kinza.anwar@riphah.edu.pk
Lareb Sattar, MS-OMPT*
About this study
Official title: Effects of Virtual Reality as an Adjunctive to Transverse Friction Massage in Pediatric Burn Patients
The aim of this randomized controlled trial is to find the effectiveness of Virtual reality as an adjunctive to transverse friction massage in pediatric burn patients for reducing pain, anxiety and enhancing elbow range of motion.
Read the detailed description
A burn injury is damage to the skin or other body parts caused by heat, chemicals, electricity, radiation, or friction.Pain or discomfort, redness and swelling, blistering, peeling skin, scarring , difficulty breathing, shock in cases of severe burn, fever as a complication of burn, anxiety and depression are some main signs and symptoms after burn injuries. Upper limb burn injuries are more common as compared to lower limb , trunk or head and neck. Physical therapy plays an important role in reducing pain and improving range of motion and prevention of contractures formation after burn injuries.
Virtual Reality training (VR) uses a computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real or physical way. In the context of burn injuries, VR can be used as a distraction technique during wound care procedures or as an adjunct to pain management, and reduction of anxiety level.
Transverse friction massage Therapy is a Cyriax technique , is applied by the fingers directly to the lesion and transverse to the direction of fibers.Pressure is applied with the ball of the practitioners thumb or fingers to the patient's skin or muscles. Friction massage applied correctly will quickly result in analgesic effect over the treated area. Friction prevents the adhesion formations as a result leads to improvement of range of motion , prevention of contractures formation as well as pain relief.
- Conditions
- Burns Elbows, Pediatric ALL
- Being tested
- Virtual Realty Training, Transverse friction massage (TFM)
- Keywords
- Virtual Reality, Pediatric burn patients,, transverse friction massage, Elbow burn injuries
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Realty TrainingOther
They would be receiving treatment as follow:
Virtual Reality is a technology that aims to completely immerse the user inside the computer generated world, giving the impression to the user that they have "stepped inside" the synthetic world. RA mobile phone , head mounted display (HMD) will be used and videos of patient's interest will be played on phone which will create a 3D world around the patient.
And while watching conventional physical therapy will be performed side by side.
Conventional PT including range of motion exercises of elbow region including flexion, extension, supination, pronation, stretching and strengthening exercises of elbow muscles. Frequency: 10 reps with 5 sec hold for 3 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins Type: Strengthening Exercises
Transverse friction massage (TFM)Other
They would be receiving treatment as follow:
Transverse friction massage (Soft tissue mobilization technique) on the surrounding burn region for 5-10min in intervals. Frequency: 3 times/week for 2 consecutive weeks. Intensity: moderate intensity (pain free) Time: 10 mins Conventional PT including range of motion exercises of elbow region including flexion, extension, supination, pronation, stretching and strengthening exercises of elbow muscles. Frequency: 10 reps with 5 sec hold for 3 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins Type: Strengthening Exercises
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality training | Active comparator | Virtual Reality + Conventional PT Receives: Other: Virtual Realty Training |
| Transverse friction massage (TFM) | Experimental | Transverse friction massage (TFM)+ Conventional PT Receives: Other: Transverse friction massage (TFM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo Elbow Performance Index
MEPI is an instrument used to test the limitations, caused by pathology, of the elbow during activities of daily living (ADL). This specific test uses 4 subscales:
- Pain,
- Range of Motion
- Stability
- Daily Function The clinical information is rated based on a 100 points scale.
- <60 - poor
- 60-74 - fair
- 75-89 - good
- 90-100 - excellent
Measured: 2 weeks
Secondary outcomes (2)
Burn Specific Pain Anxiety Scale (BSPAS)
The BSPAS is a 9 item self report scale for the assessment of pain related and anticipatory anxiety in burn patients. The items are scored on a 100 mm visual analog line with two reference points given values of 0 and 100. The reference points are identified by these numbers, and also by the expressions 'not at all' and 'the worst imaginable way'. There is no middle ranged reference position or 'neutral' point on this visual analog line.
Measured: 2 weeks
Goniometer
It is an instrument that measures the available range of motion at a joint.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start30 Aug 2023
- Primary completion28 Mar 2024 (estimated)
- Study completion28 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burns ElbowsStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kinza Anwar, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973162
- Sponsor's protocol ID
- REC/01651 Lareb Sattar
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality as an Adjunctive to Transverse Friction Massage in Pediatric Burn Patients
- ClinicalTrials.gov ID
- NCT05973162
- Acronym / sponsor ID
- REC/01651 Lareb Sattar
- Conditions
- Burns Elbows, Pediatric ALL
- Keywords
- Virtual Reality, Pediatric burn patients,, transverse friction massage, Elbow burn injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 28 Mar 2024 (estimated)
- Study completion
- 28 Apr 2024 (estimated)
- First posted
- 2 Aug 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.
The aim of this randomized controlled trial is to find the effectiveness of Virtual reality as an adjunctive to transverse friction massage in pediatric burn patients for reducing pain, anxiety and enhancing elbow range of motion.
Detailed description
A burn injury is damage to the skin or other body parts caused by heat, chemicals, electricity, radiation, or friction.Pain or discomfort, redness and swelling, blistering, peeling skin, scarring , difficulty breathing, shock in cases of severe burn, fever as a complication of burn, anxiety and depression are some main signs and symptoms after burn injuries. Upper limb burn injuries are more common as compared to lower limb , trunk or head and neck. Physical therapy plays an important role in reducing pain and improving range of motion and prevention of contractures formation after burn injuries.
Virtual Reality training (VR) uses a computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real or physical way. In the context of burn injuries, VR can be used as a distraction technique during wound care procedures or as an adjunct to pain management, and reduction of anxiety level.
Transverse friction massage Therapy is a Cyriax technique , is applied by the fingers directly to the lesion and transverse to the direction of fibers.Pressure is applied with the ball of the practitioners thumb or fingers to the patient's skin or muscles. Friction massage applied correctly will quickly result in analgesic effect over the treated area. Friction prevents the adhesion formations as a result leads to improvement of range of motion , prevention of contractures formation as well as pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality training | Active comparator | Other: Virtual Realty TrainingVirtual Reality + Conventional PT |
| Transverse friction massage (TFM) | Experimental | Other: Transverse friction massage (TFM)Transverse friction massage (TFM)+ Conventional PT |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Willingly participated in the study.
- Age group:6-18.
- Gender: both Male and Female
- Acute burn injuries of elbow region (grade 2)
- Superficial wounds healing phase( 5-10) days
Key exclusion criteria (5 listed)
- Motion sickness
- History of seizure activity
- Burns on body region that impede use of VR equipment (ears, eyes, head)
- Deep burn (Grade 3,4)
- Fractures
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 Realty TrainingThey would be receiving treatment as follow: Virtual Reality is a technology that aims to completely immerse the user inside the computer generated world, giving the impression to the user that they have "stepped inside" the synthetic world. RA mobile phone , head mounted display (HMD) will be used and videos of patient's interest will be played on phone which will create a 3D world around the patient. And while watching conventional physical therapy will be performed side by side. Conventional PT including range of motion exercises of elbow region including flexion, extension, supination, pronation, stretching and strengthening exercises of elbow muscles. Frequency: 10 reps with 5 sec hold for 3 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins Type: Strengthening Exercises | Other | Virtual Reality training |
| Transverse friction massage (TFM)They would be receiving treatment as follow: Transverse friction massage (Soft tissue mobilization technique) on the surrounding burn region for 5-10min in intervals. Frequency: 3 times/week for 2 consecutive weeks. Intensity: moderate intensity (pain free) Time: 10 mins Conventional PT including range of motion exercises of elbow region including flexion, extension, supination, pronation, stretching and strengthening exercises of elbow muscles. Frequency: 10 reps with 5 sec hold for 3 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins Type: Strengthening Exercises | Other | Transverse friction massage (TFM) |
Primary outcome
Mayo Elbow Performance Index
Time frame: 2 weeks
MEPI is an instrument used to test the limitations, caused by pathology, of the elbow during activities of daily living (ADL). This specific test uses 4 subscales: * Pain, * Range of Motion * Stability * Daily Function The clinical information is rated based on a 100 points scale. * <60 - poor * 60-74 - fair * 75-89 - good * 90-100 - excellent
2 secondary outcomes
Burn Specific Pain Anxiety Scale (BSPAS)
Time frame: 2 weeks
Goniometer
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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.
Kinza Anwar, MS-OMPT principal investigator
Riphah International 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 Virtual Realty Training and Transverse friction massage (TFM) in people with Burns Elbows and Pediatric ALL, run by Riphah International University at 1 site in Pakistan.
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 6 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: status not confirmed, as of the sponsor's last update on 5 Sep 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kinza Anwar, MS-OMPT (+92-3239735427, kinza.anwar@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mayo Elbow Performance Index (time frame: 2 weeks). 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 5 Sep 2023.