NCT07507448

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

2 days

First QC Date

March 27, 2026

Last Update Submit

March 27, 2026

Conditions

Keywords

Virtual RealitySmartphoneBurn DressingPain ManagementAnxiety ManagementNon-Pharmacological Intervention

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

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).

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.

Behavioral: Smartphone Distraction

Interventions

VRBEHAVIORAL

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).

VR Group

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.

Smartphone Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 2, 2026

Study Start

March 30, 2026

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share