Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:53 AM
Study NCT ID:
NCT07335666
Status:
COMPLETED
Last Update Posted:
2026-01-13
First Post:
2026-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Outperforms Game Card Distraction in Reducing Distress During Pediatric Wound Care
Sponsor:
Agri Ibrahim Cecen University
Organization:
Study Overview
Official Title:
Virtual Reality Versus Distraction Game Cards for Reducing Fear, Anxiety, Pain, and Physiological Stress During Pediatric Open Wound Care
Status:
COMPLETED
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR-WOUND
Brief 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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: