Virtual Reality Versus Game Card Distraction During Pediatric Wound Care (VR-WOUND)

August 31, 2026 updated by: Volkan Gokmen, Agri Ibrahim Cecen University

Virtual Reality Versus Distraction Game Cards for Reducing Fear, Anxiety, Pain, and Physiological Stress During Pediatric Open Wound Care

This completed randomized study compared two distraction approaches with standard care during pediatric open wound care. Ninety children aged 5-10 years were assigned to standard care alone, standard care plus distraction game cards, or standard care plus immersive audiovisual virtual reality. Fear, state anxiety, pain, heart rate, and peripheral oxygen saturation were assessed immediately before and shortly after wound care. The purpose was to compare psychological and physiological responses among the three groups and to assess whether virtual reality provided additional benefit compared with game cards.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open wound care procedures may cause fear, anxiety, pain, and physiological stress in children. This study was conducted in the pediatric emergency department of Ağrı Training and Research Hospital, Turkey, between April and May 2023.

Children aged 5-10 years who required open wound care were randomly allocated in a 1:1:1 ratio to standard care alone, standard care plus distraction game cards, or standard care plus immersive virtual reality. Standard care included wound cleansing, debridement, suturing when clinically indicated, and dressing.

In the game card group, a trained researcher used laminated illustrated cards with visual-search and pattern-recognition tasks and provided structured prompts throughout the procedure. In the virtual reality group, children viewed a preset sequence of passive, non-interactive, age-appropriate 360-degree three-dimensional audiovisual videos using a smartphone-based virtual reality headset throughout the procedure.

Fear, state anxiety, pain, heart rate, and peripheral oxygen saturation were measured immediately before wound care and within 5 minutes after completion. The study compared psychological and physiological responses among the three groups.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • AĞRI
      • Center, AĞRI, Turkey (Türkiye), 04100
        • Ağrı Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 5-10 years
  • Presented with an open wound requiring cleansing, dressing, debridement, and/or suturing
  • Hemodynamically stable at baseline, with peripheral oxygen saturation of at least 95 percentage and heart rate within age-appropriate limits
  • Able to communicate sufficiently to complete the study assessments
  • Written informed consent provided by a parent or legal guardian
  • Verbal assent provided by the child

Exclusion Criteria:

  • Neurodevelopmental or communication disorder that could interfere with study assessments
  • Significant visual or hearing impairment
  • Head or facial wound preventing use of the virtual reality headset
  • History of motion sickness or a previous adverse reaction to virtual reality
  • Receipt of sedatives or systemic opioid analgesics within 6 hours before the procedure
  • Requirement for procedural sedation during wound care
  • Any clinical condition judged by the attending physician to make participation inappropriate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care Control Group
Participants received standard pediatric wound care according to institutional protocols, including wound cleansing, debridement, suturing when clinically indicated, and dressing, without a structured distraction intervention.
Experimental: Distraction Game Card Group
Participants received standard wound care plus distraction using laminated illustrated game cards with visual-search and pattern-recognition tasks. A trained researcher provided structured prompts throughout wound care.
Behavioral: Distraction Game Cards
The distraction activity began immediately before wound care and continued throughout the procedure. A trained researcher used structured prompts approximately every 15-30 seconds to maintain engagement.
Experimental: Virtual Reality Distraction Group
Participants received standard wound care plus passive immersive audiovisual virtual reality delivered using a smartphone-based headset throughout the procedure.
Behavioral: Virtual Reality Distraction
A smartphone-based VR BOX 3.0 headset displayed a preset sequence of age-appropriate 360-degree three-dimensional videos with background music and ambient sounds. No hand controllers, gaze-based selection, or other interactive controls were used. The intervention began immediately before wound care and continued throughout the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Fear Scale Score
Time Frame: Immediately before wound care and within 5 minutes after completion of wound care
Fear was measured using the Children's Fear Scale. Scores range from 0 (no fear) to 4 (extreme fear), with higher scores indicating greater fear.
Immediately before wound care and within 5 minutes after completion of wound care
State-Trait Anxiety Inventory for Children-State Subscale Score
Time Frame: Immediately before wound care and within 5 minutes after completion of wound care
State anxiety was measured using the State-Trait Anxiety Inventory for Children-State subscale. Scores range from 20 to 60, with higher scores indicating greater state anxiety.
Immediately before wound care and within 5 minutes after completion of wound care
Wong-Baker FACES Pain Rating Scale Score
Time Frame: Immediately before wound care and within 5 minutes after completion of wound care
Pain intensity was measured using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain.
Immediately before wound care and within 5 minutes after completion of wound care

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: Immediately before wound care and within 5 minutes after completion of wound care
Heart rate was measured in beats per minute using a fingertip pulse oximeter after a stable 30-second recording.
Immediately before wound care and within 5 minutes after completion of wound care
Peripheral Oxygen Saturation (SpO₂)
Time Frame: Immediately before wound care and within 5 minutes after completion of wound care
Peripheral oxygen saturation was measured as a percentage using a fingertip pulse oximeter after a stable 30-second recording.
Immediately before wound care and within 5 minutes after completion of wound care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agri Ibrahim Cecen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VR-WOUNDCARE-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the parental consent process did not authorize sharing outside the research team and the small, single-center pediatric sample presents a risk of participant re-identification. Aggregate results will be reported in publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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