Ağrı Training and Research Hospital
Center, AĞRI, 04100, Turkey (Türkiye)
NCT Number: NCT07335666
Children often experience fear, anxiety, and pain during wound care procedures, which can make treatment more difficult and distressing. Non-pharmacological distraction techniques may help reduce these negative experiences without the use of medications. Virtual reality (VR) provides immersive visual and auditory stimulation, while simple distraction tools such as game cards offer a low-cost alternative.
This randomized controlled study aims to compare the effectiveness of immersive virtual reality glasses and distraction game cards in reducing fear, anxiety, pain, and physiological stress responses in children aged 5 to 10 years undergoing open wound care. Ninety children are randomly assigned to one of three groups: standard care alone, standard care with distraction game cards, or standard care with virtual reality glasses. Psychological outcomes (fear, anxiety, and pain) and physiological indicators (heart rate and oxygen saturation) are measured before and after the wound care procedure. The results of this study will help identify effective, non-pharmacological strategies to improve children's experiences during painful medical procedures and support child-centered care in pediatric clinical settings.
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Notify Me5 year–10 year
All sexes
Interventional
Not applicable
Center, AĞRI, 04100, Turkey (Türkiye)
Open wound care procedures are common in pediatric emergency settings and are frequently associated with fear, anxiety, pain, and physiological stress in children. These responses may interfere with cooperation during treatment and negatively affect children's short- and long-term perceptions of healthcare. Although pharmacological approaches can reduce pain, non-pharmacological interventions are increasingly recommended as complementary strategies to minimize distress without additional medical risk.
Distraction techniques represent one of the most widely used non-pharmacological approaches in pediatric care. Immersive virtual reality (VR) has gained attention as a promising distraction method due to its ability to provide multisensory engagement and strong attentional capture. By immersing children in an interactive virtual environment, VR may reduce awareness of painful stimuli and procedural threat. In contrast, distraction game cards offer a simple, low-cost alternative that engages children cognitively through visual search and pattern recognition tasks. Despite growing evidence supporting both approaches, direct comparisons between immersive VR and low-cost distraction methods during pediatric wound care remain limited.
This study is designed as a single-center, parallel-group randomized controlled trial conducted in the pediatric emergency department of Agri Training and Research Hospital in Turkey. Children aged 5-10 years who require open wound care, including cleansing, dressing, or suturing, are eligible to participate. Following informed consent from parents or guardians and assent from children, participants are randomly allocated in a 1:1:1 ratio to one of three groups: standard wound care alone (control group), standard care with distraction game cards, or standard care with immersive virtual reality glasses.
All participants receive wound care according to institutional clinical protocols. Children in the virtual reality group wear VR glasses displaying age-appropriate immersive content throughout the procedure. Children in the game card group engage with illustrated distraction cards facilitated by a trained researcher. Psychological outcomes, including fear, state anxiety, and pain, are assessed immediately before and shortly after the procedure using validated child-appropriate scales. Physiological responses, including heart rate and peripheral oxygen saturation, are measured concurrently using a pulse oximeter.
The primary objective of the study is to compare post-procedural fear, anxiety, and pain levels between groups. Secondary objectives include evaluation of within-group changes and comparison of physiological stress indicators across interventions. By directly comparing immersive virtual reality with a simple, low-cost distraction method, this study aims to provide clinically relevant evidence to inform the selection of effective, feasible, and scalable non-pharmacological interventions for pediatric wound care.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Children aged 5 to 10 years.
Presentation with an open wound requiring wound care procedures such as cleansing, dressing, debridement, and/or suturing.
Hemodynamic stability at baseline (peripheral oxygen saturation ≥95% and heart rate within age-appropriate limits).
Ability to communicate sufficiently to complete study assessments.
Provision of written informed consent by a parent or legal guardian.
Provision of verbal assent by the child. -
Exclusion criteria
Presence of neurodevelopmental disorders or communication impairments that could interfere with study assessments.
Significant visual or hearing impairment.
Head or facial wounds that prevent the use of virtual reality glasses.
History of motion sickness or previous adverse reactions to virtual reality.
Receipt of sedatives or systemic opioid analgesics within 6 hours prior to the procedure.
Requirement for procedural sedation during wound care.
Any clinical condition deemed by the attending physician to make participation inappropriate.
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Laminated illustrated game cards containing visual search and pattern-recognition tasks were used as a behavioral distraction during pediatric wound care. A trained researcher facilitated engagement by asking structured questions approximately every 15-30 seconds throughout the procedure to maintain the child's attention.
Immersive virtual reality distraction was delivered using virtual reality glasses connected to a smartphone displaying age-appropriate three-dimensional and 360-degree audiovisual content throughout the wound care procedure to provide multisensory engagement and reduce procedural distress.
Time frame: Immediately before the procedure and within 5 minutes after completion of wound care
Children's fear related to the wound care procedure, assessed using the Children's Fear Scale. Scores range from 0 (no fear) to 4 (extreme fear), with higher scores indicating greater fear.
Time frame: Immediately before the procedure and within 5 minutes after completion of wound care
Children's state anxiety during wound care, measured using the State Anxiety Inventory for Children. Total scores range from 20 to 60, with higher scores indicating greater anxiety.
Time frame: Immediately before the procedure and within 5 minutes after completion of wound care
Pain intensity experienced by children during wound care, assessed using the Wong-Baker Faces Pain Scale. Scores range from 0 (no pain) to 10 (worst possible pain).
Time frame: Immediately before the procedure and within 5 minutes after completion of wound care
Physiological stress response measured as heart rate (beats per minute) using a fingertip pulse oximeter during a stable 30-second recording period.
Time frame: Immediately before the procedure and within 5 minutes after completion of wound care
Physiological response measured as peripheral oxygen saturation (%) using a fingertip pulse oximeter during a stable 30-second recording period.
Agri Ibrahim Cecen University
Other
Virtual Reality Versus Distraction Game Cards for Reducing Fear, Anxiety, Pain, and Physiological Stress During Pediatric Open Wound Care
Acronym: VR-WOUND
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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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