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Completed

NCT Number: NCT07335666

Virtual Reality Versus Game Card Distraction During Pediatric 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.

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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ağrı Training and Research Hospital

Center, AĞRI, 04100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Distraction Game Cards

Behavioral

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.

Virtual Reality Distraction

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Agri Ibrahim Cecen University

Other

Registry information

Official study title

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

Acronym: VR-WOUND

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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