Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2024-01-01
2025-02-01
Brief Summary
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To evaluate the effectiveness of VR in reducing procedural anxiety, fear, and pain, and in improving compliance in children undergoing SPT.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Virtual reality
Virtual reality
VR application via a head-mounted display one minute before and throughout the SPT procedure. The VR intervention utilized a Samsung Gear VR headset (Samsung, Seoul, South Korea) in conjunction with a Samsung S7 or S8 mobile device to provide an immersive and engaging experience. Children were allowed to choose from a range of age-appropriate VR content designed to enhance engagement and relaxation. Prior to the procedure, children were trained on how to use the headset by study staff to ensure a smooth experience.
Standard of care
No interventions assigned to this group
Interventions
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Virtual reality
VR application via a head-mounted display one minute before and throughout the SPT procedure. The VR intervention utilized a Samsung Gear VR headset (Samsung, Seoul, South Korea) in conjunction with a Samsung S7 or S8 mobile device to provide an immersive and engaging experience. Children were allowed to choose from a range of age-appropriate VR content designed to enhance engagement and relaxation. Prior to the procedure, children were trained on how to use the headset by study staff to ensure a smooth experience.
Eligibility Criteria
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Inclusion Criteria
* between 4 and 18 years of age
Exclusion Criteria
* motion sickness,
* severe developmental delay,
* non-Italian-speaking patients
* Participants who had used systemic antihistamines or corticosteroids within the past seven days
4 Years
18 Years
ALL
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Roberto Berni Canani, MD, PhD
Full Professor
Locations
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Univeristy of Naples Federico II
Naples, , Italy
Countries
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Other Identifiers
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11n24
Identifier Type: -
Identifier Source: org_study_id