NCT07740850

Brief Summary

This study evaluates whether virtual reality (VR)-based distraction can reduce pain during intravenous cannulation and venous blood sampling in children treated in a pediatric emergency department. Children aged 6-11 years who required these procedures received either standard care or VR distraction using age-appropriate audiovisual content. The primary outcome was procedure-related pain measured by the Wong-Baker FACES Pain Rating Scale. Secondary outcomes included procedural duration, cooperation, first-attempt success, behavioral distress, and parental satisfaction. The study also explored whether the effectiveness of VR was associated with patient engagement during the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

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

September 13, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
Last Updated

August 3, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

May 21, 2026

Last Update Submit

July 31, 2026

Conditions

Keywords

Virtual RealityPediatric Emergency DepartmentProcedural PainIntravenous CannulationVenous Blood SamplingPain ManagementDistraction Therapy

Outcome Measures

Primary Outcomes (1)

  • Procedure-related pain

    Procedure-related pain assessed using the Wong-Baker FACES Pain Rating Scale (WBFPS) following intravenous cannulation or venous blood sampling.

    Immediately after the procedure

Study Arms (1)

Virtual Reality Group

EXPERIMENTAL

Children received age-appropriate audiovisual distraction through a virtual reality headset during intravenous cannulation or venous blood sampling procedures.

Device: Virtual Reality-Based Distraction

Interventions

Participants received age-appropriate audiovisual distraction through a virtual reality headset (Meta Quest 3S) during intravenous cannulation or venous blood sampling. The intervention aimed to reduce procedural pain and distress by redirecting attention away from the procedure toward immersive VR content.

Virtual Reality Group

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6-11 years
  • Requirement for intravenous cannulation or venous blood sampling in the -pediatric emergency department
  • Ability to understand and engage with virtual reality content
  • Written informed consent obtained from parent or legal guardian

You may not qualify if:

  • Visual or hearing impairment preventing VR use
  • Neurological or developmental disorders affecting communication or cooperation
  • Altered level of consciousness
  • Hemodynamic instability requiring immediate intervention
  • Previous participation in the study
  • Refusal of participation by the child or parent/legal guardian
  • Contraindications to virtual reality exposure (e.g., severe motion sickness or intolerance)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, ProceduralAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Emergency Medicine Specialist

Study Record Dates

First Submitted

May 21, 2026

First Posted

August 3, 2026

Study Start

September 13, 2024

Primary Completion

January 22, 2026

Study Completion

January 22, 2026

Last Updated

August 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be publicly shared because the study includes pediatric participants, and data sharing may increase the risk of participant re-identification. De-identified data may be made available upon reasonable request to the corresponding author, subject to institutional ethics approval and applicable regulations.

Locations