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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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