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Not yet recruiting NCT07507448

EFFECTS OF VİRTUAL REALİTY AND MOBİLE PHONE-BASED DİSTRACTİON ON PAİN AND ANXİETY DURİNG BURN DRESSİNG CHANGES: A RANDOMİZED CONTROLLED TRİAL

No phase Interventional Burns Degree Second

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR, Smartphone Distraction.
Who it may be relevant to
Registry conditions: Burns Degree Second. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Behavioral VR
    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).
  • Behavioral Smartphone Distraction
    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.

Primary outcome measures

  • Visual Analog Scale (VAS) [Time frame: Immediately after the dressing procedure]
  • Burn-Specific Pain Anxiety Scale (BSPAS) [Time frame: Immediately after the dressing procedure]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07507448 · ASE-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗