NCT07739381

Brief Summary

This randomized controlled trial was conducted to evaluate the effects of virtual reality and tablet-based audiovisual distraction on pain, anxiety, and fear in children undergoing intravenous cannulation in a pediatric emergency department. Children aged 7 to 12 years were randomly assigned to three groups: virtual reality, tablet, and control. During intravenous cannulation, children in the virtual reality group watched an entertaining video using a virtual reality headset, while children in the tablet group watched the same video on a tablet. Children in the control group received routine care without an audiovisual distraction intervention. Pain, anxiety, and fear were assessed using age-appropriate validated scales. The study compared the effects of the two distraction methods with routine care and with each other.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

virtual realitytabletchildrenfearanxiety

Outcome Measures

Primary Outcomes (1)

  • Pain During Intravenous Cannulation

    Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale. The scale consists of six facial expressions representing increasing levels of pain. Scores range from 0 to 10, with higher scores indicating greater pain intensity. Pain was assessed immediately after intravenous cannulation.

    Immediately after intravenous cannulation

Secondary Outcomes (1)

  • Anxiety Before and After Intravenous Cannulation

    Immediately before and immediately after intravenous cannulation

Study Arms (3)

Virtual Reality Group

EXPERIMENTAL

Children watched an age-appropriate entertaining video using a virtual reality headset during intravenous cannulation.

Behavioral: Virtual Reality Distraction

tablet Group

EXPERIMENTAL

Children watched the same age-appropriate entertaining video on a tablet during intravenous cannulation.

Behavioral: Tablet Distraction

control group

NO INTERVENTION

Children underwent intravenous cannulation according to routine clinical practice without any audiovisual distraction intervention.

Interventions

Children in the virtual reality group received virtual reality-based distraction during intravenous cannulation. A virtual reality headset was used to divert the child's attention from the procedure.

Virtual Reality Group

Children in the tablet group watched an age-appropriate cartoon on a tablet during intravenous cannulation to divert their attention from the procedure.

tablet Group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • It was that the child belonged to the 7-12 age group and was fully conscious.

You may not qualify if:

  • Children with hearing, cognitive, or visual impairments; children unaccompanied by a parent; children with whom communication cannot be established; and children with critical health issues and/or conditions requiring immediate intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Evliya Çelebi Training and Research Hospital

Kütahya, Kütahya, 4300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, ProceduralAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1:1 ratio to the virtual reality, tablet, or control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research asisstant

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start

April 1, 2022

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations