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Virtual Reality Versus Game Card Distraction During Pediatric Wound Care

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07335666
Acronym
VR-WOUND
Enrollment
90
Registered
2026-01-13
Start date
2023-04-01
Completion date
2023-05-30
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Wounds, Procedural Fear, Procedural Pain, Procedure-Related Anxiety

Keywords

Virtual Reality, Distraction Techniques, Game Card Distraction, Immersive Distraction, Pediatric Wound Care, Child-Centered Care, Non-Pharmacological Intervention, Procedural Pain Management, Procedural Anxiety

Brief summary

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.

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.

Interventions

BEHAVIORALDistraction 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.

BEHAVIORALVirtual 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.

Sponsors

Agri Ibrahim Cecen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Participants and intervention providers were not masked. A separate research assistant who did not deliver the interventions and was not informed of group allocation administered the outcome measures and entered the data. Psychological outcomes were child self-reports, and participants were aware of the intervention they received.

Intervention model description

Participants were randomly assigned in a 1:1:1 ratio to three parallel groups: standard care alone, standard care plus distraction game cards, or standard care plus immersive audiovisual virtual reality.

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Children's Fear Scale ScoreImmediately before wound care and within 5 minutes after completion of wound careFear was measured using the Children's Fear Scale. Scores range from 0 (no fear) to 4 (extreme fear), with higher scores indicating greater fear.
State-Trait Anxiety Inventory for Children-State Subscale ScoreImmediately before wound care and within 5 minutes after completion of wound careState 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.
Wong-Baker FACES Pain Rating Scale ScoreImmediately before wound care and within 5 minutes after completion of wound carePain 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.

Secondary

MeasureTime frameDescription
Heart RateImmediately before wound care and within 5 minutes after completion of wound careHeart rate was measured in beats per minute using a fingertip pulse oximeter after a stable 30-second recording.
Peripheral Oxygen Saturation (SpO₂)Immediately before wound care and within 5 minutes after completion of wound carePeripheral oxygen saturation was measured as a percentage using a fingertip pulse oximeter after a stable 30-second recording.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026