An interventional study of Distraction Game Cards and Virtual Reality Distraction in Pediatric Wounds, Procedural Pain and Procedure-Related Anxiety, sponsored by Agri Ibrahim Cecen University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Agri Ibrahim Cecen University · Not applicable, Interventional, and Supportive 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.
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.
237 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's enrollment of 90 is close to the median of 83 across 223 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Agri Ibrahim Cecen University is the lead sponsor of 39 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Participants received standard pediatric wound care according to institutional protocols, including wound cleansing, debridement, suturing when clinically indicated, and dressing, without a structured distraction intervention.
Participants received standard wound care plus distraction using laminated illustrated game cards with visual-search and pattern-recognition tasks. A trained researcher provided structured prompts throughout wound care.
Behavioral: Distraction Game Cards
Participants received standard wound care plus passive immersive audiovisual virtual reality delivered using a smartphone-based headset throughout the procedure.
Behavioral: Virtual Reality Distraction
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.
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.
Children's Fear Scale Score
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.
Time frame: Immediately before wound care and within 5 minutes after completion of wound care
State-Trait Anxiety Inventory for Children-State Subscale Score
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.
Time frame: Immediately before wound care and within 5 minutes after completion of wound care
Wong-Baker FACES Pain Rating Scale Score
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.
Time frame: Immediately before wound care and within 5 minutes after completion of wound care
Heart Rate
Heart rate was measured in beats per minute using a fingertip pulse oximeter after a stable 30-second recording.
Time frame: Immediately before wound care and within 5 minutes after completion of wound care
Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation was measured as a percentage using a fingertip pulse oximeter after a stable 30-second recording.
Time frame: Immediately before wound care and within 5 minutes after completion of wound care
Plan to share: No — Individual participant data will not be shared because the parental consent process did not authorize sharing outside the research team and the small, single-center pediatric sample presents a risk of participant re-identification. Aggregate results will be reported in publications.
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Agri Ibrahim Cecen University