Effect of Virtual Reality and Serious Games on Pain, Fear, Anxiety, and Satisfaction During Skin Prick Testing in Children

NCT ID: NCT06993259

Last Updated: 2025-05-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-05-15

Brief Summary

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This randomized controlled trial evaluated the effectiveness of virtual reality (VR) and serious gaming (SG) in reducing pain, fear, and anxiety, and improving satisfaction during skin prick testing (SPT) in children aged 6-12 years. A total of 90 children were randomly assigned to three groups: standard care (control), VR, or SG. The VR group watched a 360° animated video using a headset, while the SG group played Subway Surfers on a tablet. Pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction (VAS) were measured post-procedure.

Detailed Description

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Conditions

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Pain Anxiety Fear Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This research was designed as a randomized controlled trial with a parallel-group structure (intervention-control) to examine the effects of serious gaming and virtual reality interventions on reducing pain, fear, and anxiety levels, as well as improving care satisfaction among children aged 6-12 years who underwent skin prick tests.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Serious Game

Group Type EXPERIMENTAL

Serious game

Intervention Type DEVICE

Children in the serious game group played Subway Surfers on a tablet starting three minutes before and continuing throughout the skin prick test. The game was chosen by pediatric experts for its age-appropriateness and ability to sustain attention without overstimulation. As a fast-paced, interactive tool, it served as an effective distraction to reduce pain, fear, and anxiety. After the procedure, children and parents rated pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction using structured feedback forms.

Virtual Reality

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type DEVICE

Children in the virtual reality (VR) group watched a 360° Ice Age video via headset starting three minutes before and continuing throughout the allergy test. The video, selected by pediatric experts, was age-appropriate, visually rich, and emotionally neutral. VR provided immersive distraction to reduce pain, fear, and anxiety. After the test, children and parents rated pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction through structured forms.

Interventions

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Virtual Reality

Children in the virtual reality (VR) group watched a 360° Ice Age video via headset starting three minutes before and continuing throughout the allergy test. The video, selected by pediatric experts, was age-appropriate, visually rich, and emotionally neutral. VR provided immersive distraction to reduce pain, fear, and anxiety. After the test, children and parents rated pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction through structured forms.

Intervention Type DEVICE

Serious game

Children in the serious game group played Subway Surfers on a tablet starting three minutes before and continuing throughout the skin prick test. The game was chosen by pediatric experts for its age-appropriateness and ability to sustain attention without overstimulation. As a fast-paced, interactive tool, it served as an effective distraction to reduce pain, fear, and anxiety. After the procedure, children and parents rated pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction using structured feedback forms.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children aged 6 to 12 years
* Scheduled to undergo an allergy skin prick test
* No visual impairments
* No use of anxiolytic or analgesic medication within the past six hours
* Voluntary agreement to participate (child assent and parental consent)

Exclusion Criteria

* Not within the 6-12 age range
* Not scheduled for an allergy skin prick test
* Presence of visual impairments
* Use of anxiolytic or analgesic medication within the past six hours
* Refusal to participate
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Trakya University

OTHER

Sponsor Role lead

Responsible Party

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Remziye Semerci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Koç University

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KOC_UNI

Identifier Type: -

Identifier Source: org_study_id

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