Burns Degree SecondNCT07507448
EFFECTS OF VİRTUAL REALİTY AND MOBİLE PHONE-BASED DİSTRACTİON ON PAİN AND ANXİETY DURİNG BURN DRESSİNG CHANGES: A RANDOMİZED CONTROLLED TRİAL
A study testing VR and Smartphone Distraction in people with Burns Degree Second, run by Senem Andı.
Trial summary
This randomized controlled trial aims to evaluate the effects of virtual reality (VR) and smartphone-based distraction methods on pain and anxiety during dressing changes in outpatients with burns. A total of 99 patients, with 33 in each group, will be randomly assigned to VR, smartphone, or control groups. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns Degree Second
- What is being tested?
- VR and Smartphone Distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years presenting to the burn outpatient clinic for dressing changes, Patients with second-degree burns involving ≤15% total body surface area (TBSA), Patients who are able to communicate verbally and in writing, Patients who have not used any pharmacological or non-pharmacological interventions that may affect pain within the last 24 hours, Patients who provide informed consent to participate in the study.
Who cannot join
- Patients with cognitive, auditory, or visual impairments that may interfere with study participation, Patients with burns located on the face or head that may prevent the use of VR equipment, Patients with any condition that may affect pain perception or the ability to complete study procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This randomized controlled trial aims to evaluate the effects of virtual reality (VR) and smartphone-based distraction methods on pain and anxiety during dressing changes in outpatients with burns. A total of 99 patients, with 33 in each group, will be randomly assigned to VR, smartphone, or control groups. Pain and anxiety will be assessed immediately after dressing using the Visual Analog Scale (VAS) and Burn-Specific Pain Anxiety Scale (BSPAS). The study is expected to provide evidence on non-pharmacological distraction methods that may improve patient comfort during burn care.
Read the detailed description
This study will recruit 99 outpatients attending a hospital burn center, with 33 patients in each group. Participants will be randomly assigned to one of three groups: VR, smartphone, or control.
VR Group: Patients will receive standard visual and auditory content via a VR headset during dressing changes.
Smartphone Group: Patients will use self-selected visual and auditory content on their personal smartphones during dressing changes.
Control Group: Patients will receive standard burn care without any distraction intervention.
Pain and anxiety will be measured immediately after the dressing procedure using the Visual Analog Scale (VAS) and Burn-Specific Pain Anxiety Scale (BSPAS).
- Conditions
- Burns Degree Second
- Being tested
- VR, Smartphone Distraction
- Keywords
- Virtual Reality, Smartphone, Burn Dressing, Pain Management, Anxiety Management, Non-Pharmacological Intervention
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRBehavioural
Participants will receive standard visual and auditory content via a VR headset during burn dressing changes. The intervention aims to distract patients from pain and anxiety. Pain and anxiety will be assessed immediately after the procedure using the Visual Analog Scale (VAS) and Burn-Specific Pain Anxiety Scale (BSPAS).
Smartphone DistractionBehavioural
Participants will use self-selected visual and auditory content on their personal smartphones during burn dressing changes to reduce pain and anxiety. Pain and anxiety will be measured immediately after the procedure using VAS and BSPAS.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants will receive standard burn care without any distraction intervention. Pain and anxiety will be assessed immediately after the procedure using VAS and BSPAS. |
| VR Group | Experimental | Participants will receive standard visual and auditory content via a VR headset during burn dressing changes. Pain and anxiety will be assessed immediately after the procedure using the Visual Analog Scale (VAS) and Burn-Specific Pain Anxiety Scale (BSPAS). Receives: Behavioral: VR |
| Smartphone Group | Experimental | Participants will use self-selected visual and auditory content on their personal smartphones during burn dressing changes. Pain and anxiety will be assessed immediately after the procedure using VAS and BSPAS. Receives: Behavioral: Smartphone Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Pain intensity measured by Visual Analog Scale (VAS)
Measured: Immediately after the dressing procedure
Burn-Specific Pain Anxiety Scale (BSPAS)
Anxiety level measured by Burn-Specific Pain Anxiety Scale (BSPAS)
Measured: Immediately after the dressing procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start30 Mar 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burns Degree SecondStudies 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
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Senem Andı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Senem Andı, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507448
- Sponsor's protocol ID
- ASE-1
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- 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 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF VİRTUAL REALİTY AND MOBİLE PHONE-BASED DİSTRACTİON ON PAİN AND ANXİETY DURİNG BURN DRESSİNG CHANGES: A RANDOMİZED CONTROLLED TRİAL
- ClinicalTrials.gov ID
- NCT07507448
- Acronym / sponsor ID
- ASE-1
- Conditions
- Burns Degree Second
- Keywords
- Virtual Reality, Smartphone, Burn Dressing, Pain Management, Anxiety Management, Non-Pharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Senem AndıUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 2 Apr 2026 (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 aims to evaluate the effects of virtual reality (VR) and smartphone-based distraction methods on pain and anxiety during dressing changes in outpatients with burns. A total of 99 patients, with 33 in each group, will be randomly assigned to VR, smartphone, or control groups. Pain and anxiety will be assessed immediately after dressing using the Visual Analog Scale (VAS) and Burn-Specific Pain Anxiety Scale (BSPAS). The study is expected to provide evidence on non-pharmacological distraction methods that may improve patient comfort during burn care.
Detailed description
This study will recruit 99 outpatients attending a hospital burn center, with 33 patients in each group. Participants will be randomly assigned to one of three groups: VR, smartphone, or control.
VR Group: Patients will receive standard visual and auditory content via a VR headset during dressing changes.
Smartphone Group: Patients will use self-selected visual and auditory content on their personal smartphones during dressing changes.
Control Group: Patients will receive standard burn care without any distraction intervention.
Pain and anxiety will be measured immediately after the dressing procedure using the Visual Analog Scale (VAS) and Burn-Specific Pain Anxiety Scale (BSPAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants will receive standard burn care without any distraction intervention. Pain and anxiety will be assessed immediately after the procedure using VAS and BSPAS. |
| VR Group | Experimental | Behavioral: VRParticipants will receive standard visual and auditory content via a VR headset during burn dressing changes. Pain and anxiety will be assessed immediately after the procedure using the Visual Analog Scale (VAS) and Burn-Specific Pain Anxiety Scale (BSPAS). |
| Smartphone Group | Experimental | Behavioral: Smartphone DistractionParticipants will use self-selected visual and auditory content on their personal smartphones during burn dressing changes. Pain and anxiety will be assessed immediately after the procedure using VAS and BSPAS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-65 years presenting to the burn outpatient clinic for dressing changes, Patients with second-degree burns involving ≤15% total body surface area (TBSA), Patients who are able to communicate verbally and in writing, Patients who have not used any pharmacological or non-pharmacological interventions that may affect pain within the last 24 hours, Patients who provide informed consent to participate in the study.
Key exclusion criteria (1 listed)
- Patients with cognitive, auditory, or visual impairments that may interfere with study participation, Patients with burns located on the face or head that may prevent the use of VR equipment, Patients with any condition that may affect pain perception or the ability to complete study procedures.
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 |
|---|---|---|
| VRParticipants will receive standard visual and auditory content via a VR headset during burn dressing changes. The intervention aims to distract patients from pain and anxiety. Pain and anxiety will be assessed immediately after the procedure using the Visual Analog Scale (VAS) and Burn-Specific Pain Anxiety Scale (BSPAS). | Behavioural | VR Group |
| Smartphone DistractionParticipants will use self-selected visual and auditory content on their personal smartphones during burn dressing changes to reduce pain and anxiety. Pain and anxiety will be measured immediately after the procedure using VAS and BSPAS. | Behavioural | Smartphone Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Immediately after the dressing procedure
Pain intensity measured by Visual Analog Scale (VAS)
Burn-Specific Pain Anxiety Scale (BSPAS)
Time frame: Immediately after the dressing procedure
Anxiety level measured by Burn-Specific Pain Anxiety Scale (BSPAS)
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 2 Apr 2026.
- Individual participant dataSharing planned: No
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The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
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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.
Questions about this trial
What is this clinical trial studying?
A study testing VR and Smartphone Distraction in people with Burns Degree Second, run by Senem Andı.
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 1 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: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Senem Andı, PhD (+905077257047, senemperktas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Immediately after the dressing procedure). 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 2 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.