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

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое 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).
• Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07507448 · ASE-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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