Virtual Reality Outperforms Game Card Distraction in Reducing Distress During Pediatric Wound Care (NCT07335666) | Clinical Trial Compass
CompletedNot Applicable
Virtual Reality Outperforms Game Card Distraction in Reducing Distress During Pediatric Wound Care
Turkey (Türkiye)90 participantsStarted 2023-04-01
Plain-language summary
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.
Who can participate
Age range
5 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Procedural Fear
Timeframe: Immediately before the procedure and within 5 minutes after completion of wound care
2
Procedural Anxiety
Timeframe: Immediately before the procedure and within 5 minutes after completion of wound care
3
Procedural Pain Intensity
Timeframe: Immediately before the procedure and within 5 minutes after completion of wound care