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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Burns Degree Second
• Intervention / Treatment: Behavioral: VR; Behavioral: Smartphone Distraction

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 Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Senem Andı, PhD; Phone Number: +905077257047; Email: senemperktas@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Participants will receive standard burn care without any distraction intervention. Pain and anxiety will be assessed immediately after the procedure using VAS and BSPAS.
Experimental: VR Group; 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).	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).
Experimental: Smartphone Group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Pain intensity measured by Visual Analog Scale (VAS)	Immediately after the dressing procedure
Burn-Specific Pain Anxiety Scale (BSPAS)	Anxiety level measured by Burn-Specific Pain Anxiety Scale (BSPAS)	Immediately after the dressing procedure

Collaborators and Investigators

• Sponsor: Senem Andı

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Smartphone; Virtual Reality; Pain Management; Non-Pharmacological Intervention; Burn Dressing; Anxiety Management
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: ASE-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No