BurnsVR-BurnNCT06913270
Virtual Reality Adjunct for Procedural Pain and Anxiety Management in Burn Wound Care
A study testing Immersive Virtual Reality Distraction (IVRD) and Nature Video Distraction (NVD) in people with Burns and Burn Wound, run by Al Hayah University In Cairo at 1 site in Egypt.
Trial summary
This randomized controlled trial is designed to evaluate the efficacy of immersive virtual reality (VR) as an adjunct to standard analgesia during dressing changes in adult burn patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burns, Burn Wound, Procedural Pain
- What is being tested?
- Immersive Virtual Reality Distraction (IVRD) and Nature Video Distraction (NVD)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2025to 25 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult burn patients (18-65 years) with confirmed partial-thickness burns. Scheduled for routine dressing changes. Able to provide informed consent. Baseline pain score of ≥4/10 during a dressing change session.
Who cannot join
- Patients with cognitive impairment preventing comprehension of the intervention.
- History of severe motion sickness or visual impairments that preclude the use of VR devices.
- Patients with contraindications to standard analgesic care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Al Hayah University
Cairo, 12111
Mohamed ElMeligie, Ph.D, 1159880001 ext. +20, mohamed.elmeligie@ahuc.edu.eg
About this study
Official title: Efficacy of Virtual Reality as an Adjunct for Procedural Pain and Anxiety Management in Burn Wound Care: A Single-Center, Randomized Controlled Trial
This randomized controlled trial is designed to evaluate the efficacy of immersive virtual reality (VR) as an adjunct to standard analgesia during dressing changes in adult burn patients. The study compares an intervention group receiving standard care combined with an immersive VR distraction (using a head-mounted display displaying an engaging virtual environment) versus a control group receiving standard care plus non-VR distraction (watching a nature video on a tablet). The primary outcomes include procedural pain intensity measured by the Visual Analog Scale (VAS) and anxiety levels measured by the State-Trait Anxiety Inventory (STAI). Secondary outcomes include patient satisfaction and physiological parameters (heart rate and blood pressure) recorded during the procedure. This trial addresses the critical gap of heterogeneity and small sample sizes noted in previous VR studies for burn care pain management (Dascal et al., 2017).
Read the detailed description
Procedural pain during dressing changes for burn wound care remains a substantial clinical challenge affecting both patient comfort and treatment compliance. Immersive VR technology has been suggested as an effective distraction technique, potentially reducing pain and associated anxiety by providing a highly engaging alternative sensory input. However, previous studies have been limited by variable protocols and modest sample sizes.
In this single-center RCT, adult burn patients aged 18-65 years with partial-thickness burns scheduled for routine dressing changes will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either:
Intervention Group: Standard care (analgesia as per institutional protocol) plus immersive VR distraction (using a commercially available head-mounted display with interactive virtual environments) Control Group: Standard care plus non-VR distraction, operationalized as watching a nature video on a tablet device.
Randomization will be computer generated.
Outcome assessors will be blinded to treatment assignment. The primary outcome measures are procedural pain intensity (assessed using a 10-cm Visual Analog Scale immediately post-procedure) and anxiety (assessed using the State-Trait Anxiety Inventory immediately post-procedure). Secondary endpoints include patient-reported satisfaction with the distraction modality and objective physiological parameters (heart rate and blood pressure) monitored throughout the procedure.
Data will be collected at each dressing change session over the study period, and repeated measures analysis will be applied to assess between-group differences.
- Conditions
- Burns, Burn Wound, Procedural Pain, Anxiety Acute
- Being tested
- Immersive Virtual Reality Distraction (IVRD), Nature Video Distraction (NVD)
- Medical subject headings
- Burns, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality Distraction (IVRD)Behavioural
Intervention Description:
Participants assigned to this intervention will receive standard analgesic care per institutional protocol in addition to an immersive virtual reality (VR) distraction intervention. During each burn dressing change, participants will wear a head-mounted display (HMD) that delivers an interactive and engaging virtual environment designed specifically to distract from procedural pain and reduce anxiety. The VR session will last for the entire duration of the dressing change (approximately 10-15 minutes) and will be administered during every session. The VR system is calibrated to provide high levels of sensory immersion to effectively divert attention from painful stimuli.
Nature Video Distraction (NVD)Behavioural
Intervention Description:
Participants in this intervention will receive the same standard analgesic care provided to all subjects and, in addition, will watch a nature video on a tablet device during the burn dressing change. The video distraction serves as an active comparator to the immersive VR. The nature video is selected to be calming and engaging, and it will be played continuously during the dressing change session (approximately 10-15 minutes). This intervention allows evaluation of whether immersive VR provides additional benefit in reducing procedural pain and anxiety over a standard video distraction.
| Study group | Role | What they receive |
|---|---|---|
| VR Distraction | Experimental | Participants in this arm will receive standard analgesic care according to institutional protocols plus an immersive virtual reality (VR) distraction intervention. During each burn dressing change, participants will wear a head-mounted display delivering an interactive, engaging virtual environment specifically designed for distraction. This arm aims to assess the efficacy of VR in reducing procedural pain intensity and anxiety compared to the control condition. Receives: Behavioral: Immersive Virtual Reality Distraction (IVRD) |
| Nature Video Distraction | Active comparator | Participants in this arm will receive the same standard analgesic care as the experimental group and will be provided with a non-VR distraction intervention. They will watch a nature video displayed on a tablet device during each burn dressing change session. This comparator is designed to control for the effects of distraction, allowing assessment of whether immersive VR provides additional benefit beyond conventional video distraction. Receives: Behavioral: Nature Video Distraction (NVD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Status via Burn Specific Health Scale - Brief (BSHS-B)
The Burn Specific Health Scale - Brief (BSHS-B) is a validated questionnaire designed to assess physical, psychosocial, and functional outcomes in burn survivors. It evaluates domains such as physical functioning, pain, emotional health, and social reintegration. Changes in functional status over time will help determine the impact of the burn injury and the effect of the intervention on recovery.
Measured: Assessments will be conducted at baseline (within 2 weeks post-discharge) and at follow-up visits at 3, 6, and 12 months.
Return-to-Work Rate
This outcome measure evaluates the proportion of participants who have successfully returned to work at 12 months post-discharge. Return-to-work status will be verified by self-report and cross-referenced with available medical and employment records, serving as an indicator of long-term functional recovery and social reintegration.
Measured: Assessed at 12 months post-discharge.
Secondary outcomes (3)
Quality of Life (QoL) via SF-36 Health Survey
The SF-36 Health Survey is a comprehensive, validated instrument designed to measure quality of life across eight domains, including physical functioning, bodily pain, general health perceptions, vitality, social functioning, role limitations due to physical and emotional problems, and mental health. This will provide insight into the broader impact of burn injuries and recovery over time.
Measured: Evaluations will occur at baseline (within 2 weeks post-discharge) and at 3, 6, and 12 months follow-up.
Range of Motion (ROM) Measurements
Range of motion (ROM) in the affected areas will be assessed using standardized goniometry. This measurement quantifies physical mobility and joint function, providing objective data on the physical recovery and potential functional limitations post-burn injury.
Measured: Measurements will be recorded at baseline and at follow-up visits at 3, 6, and 12 months.
Psychological Well-Being via Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a validated self-report questionnaire used to assess anxiety and depressive symptoms. Improving psychological well-being is a key aspect of overall recovery for burn survivors.
Measured: HADS assessments will be administered at baseline (within 2 weeks post-discharge) and then at 3, 6, and 12 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start12 Apr 2025 (estimated)
- Primary completion25 May 2026 (estimated)
- Study completion25 May 2026 (estimated)
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.
- 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
- Model description
- Participants are randomly assigned to one of two parallel arms evaluating two distraction strategies during burn dressing changes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayah University In Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913270
- Sponsor's protocol ID
- VRBURN2025-01
- Acronym
- VR-Burn
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality as an Adjunct for Procedural Pain and Anxiety Management in Burn Wound Care: A Single-Center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06913270
- Acronym / sponsor ID
- VR-Burn / VRBURN2025-01
- Conditions
- Burns, Burn Wound, Procedural Pain, Anxiety Acute
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al Hayah University In CairoUniversity, hospital or other
- Study start
- 12 Apr 2025 (estimated)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 25 May 2026 (estimated)
- First posted
- 6 Apr 2025 (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 randomized controlled trial is designed to evaluate the efficacy of immersive virtual reality (VR) as an adjunct to standard analgesia during dressing changes in adult burn patients. The study compares an intervention group receiving standard care combined with an immersive VR distraction (using a head-mounted display displaying an engaging virtual environment) versus a control group receiving standard care plus non-VR distraction (watching a nature video on a tablet). The primary outcomes include procedural pain intensity measured by the Visual Analog Scale (VAS) and anxiety levels measured by the State-Trait Anxiety Inventory (STAI). Secondary outcomes include patient satisfaction and physiological parameters (heart rate and blood pressure) recorded during the procedure. This trial addresses the critical gap of heterogeneity and small sample sizes noted in previous VR studies for burn care pain management (Dascal et al., 2017).
Detailed description
Procedural pain during dressing changes for burn wound care remains a substantial clinical challenge affecting both patient comfort and treatment compliance. Immersive VR technology has been suggested as an effective distraction technique, potentially reducing pain and associated anxiety by providing a highly engaging alternative sensory input. However, previous studies have been limited by variable protocols and modest sample sizes.
In this single-center RCT, adult burn patients aged 18-65 years with partial-thickness burns scheduled for routine dressing changes will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either:
Intervention Group: Standard care (analgesia as per institutional protocol) plus immersive VR distraction (using a commercially available head-mounted display with interactive virtual environments) Control Group: Standard care plus non-VR distraction, operationalized as watching a nature video on a tablet device.
Randomization will be computer generated.
Outcome assessors will be blinded to treatment assignment. The primary outcome measures are procedural pain intensity (assessed using a 10-cm Visual Analog Scale immediately post-procedure) and anxiety (assessed using the State-Trait Anxiety Inventory immediately post-procedure). Secondary endpoints include patient-reported satisfaction with the distraction modality and objective physiological parameters (heart rate and blood pressure) monitored throughout the procedure.
Data will be collected at each dressing change session over the study period, and repeated measures analysis will be applied to assess between-group differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel arms evaluating two distraction strategies during burn dressing changes.
| Arm | Type | Receives |
|---|---|---|
| VR Distraction | Experimental | Behavioral: Immersive Virtual Reality Distraction (IVRD)Participants in this arm will receive standard analgesic care according to institutional protocols plus an immersive virtual reality (VR) distraction intervention. During each burn dressing change, participants will wear a head-mounted display delivering an interactive, engaging virtual environment specifically designed for distraction. This arm aims to assess the efficacy of VR in reducing procedural pain intensity and anxiety compared to the control condition. |
| Nature Video Distraction | Active comparator | Behavioral: Nature Video Distraction (NVD)Participants in this arm will receive the same standard analgesic care as the experimental group and will be provided with a non-VR distraction intervention. They will watch a nature video displayed on a tablet device during each burn dressing change session. This comparator is designed to control for the effects of distraction, allowing assessment of whether immersive VR provides additional benefit beyond conventional video distraction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult burn patients (18-65 years) with confirmed partial-thickness burns. Scheduled for routine dressing changes. Able to provide informed consent. Baseline pain score of ≥4/10 during a dressing change session.
Key exclusion criteria (3 listed)
- Patients with cognitive impairment preventing comprehension of the intervention.
- History of severe motion sickness or visual impairments that preclude the use of VR devices.
- Patients with contraindications to standard analgesic care.
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 |
|---|---|---|
| Immersive Virtual Reality Distraction (IVRD)Intervention Description: Participants assigned to this intervention will receive standard analgesic care per institutional protocol in addition to an immersive virtual reality (VR) distraction intervention. During each burn dressing change, participants will wear a head-mounted display (HMD) that delivers an interactive and engaging virtual environment designed specifically to distract from procedural pain and reduce anxiety. The VR session will last for the entire duration of the dressing change (approximately 10-15 minutes) and will be administered during every session. The VR system is calibrated to provide high levels of sensory immersion to effectively divert attention from painful stimuli. | Behavioural | VR Distraction |
| Nature Video Distraction (NVD)Intervention Description: Participants in this intervention will receive the same standard analgesic care provided to all subjects and, in addition, will watch a nature video on a tablet device during the burn dressing change. The video distraction serves as an active comparator to the immersive VR. The nature video is selected to be calming and engaging, and it will be played continuously during the dressing change session (approximately 10-15 minutes). This intervention allows evaluation of whether immersive VR provides additional benefit in reducing procedural pain and anxiety over a standard video distraction. | Behavioural | Nature Video Distraction |
Primary outcome
Functional Status via Burn Specific Health Scale - Brief (BSHS-B)
Time frame: Assessments will be conducted at baseline (within 2 weeks post-discharge) and at follow-up visits at 3, 6, and 12 months.
The Burn Specific Health Scale - Brief (BSHS-B) is a validated questionnaire designed to assess physical, psychosocial, and functional outcomes in burn survivors. It evaluates domains such as physical functioning, pain, emotional health, and social reintegration. Changes in functional status over time will help determine the impact of the burn injury and the effect of the intervention on recovery.
Return-to-Work Rate
Time frame: Assessed at 12 months post-discharge.
This outcome measure evaluates the proportion of participants who have successfully returned to work at 12 months post-discharge. Return-to-work status will be verified by self-report and cross-referenced with available medical and employment records, serving as an indicator of long-term functional recovery and social reintegration.
3 secondary outcomes
Quality of Life (QoL) via SF-36 Health Survey
Time frame: Evaluations will occur at baseline (within 2 weeks post-discharge) and at 3, 6, and 12 months follow-up.
Range of Motion (ROM) Measurements
Time frame: Measurements will be recorded at baseline and at follow-up visits at 3, 6, and 12 months.
Psychological Well-Being via Hospital Anxiety and Depression Scale (HADS)
Time frame: HADS assessments will be administered at baseline (within 2 weeks post-discharge) and then at 3, 6, and 12 months follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality Distraction (IVRD) and Nature Video Distraction (NVD) in people with Burns and Burn Wound, run by Al Hayah University In Cairo 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Zoheiry, Ph.D (1277774949 ext. +20, ibrahim.alzoheiry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Status via Burn Specific Health Scale - Brief (BSHS-B) (time frame: Assessments will be conducted at baseline (within 2 weeks post-discharge) and at follow-up visits at 3, 6, and 12 months.). 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?
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 6 Apr 2025.