- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07740850
Virtual Reality for Procedural Pain During IV Cannulation in Children (VR-PED)
The Impact of Virtual Reality Distraction on Procedural Pain, Duration, and Parental Satisfaction During Intravenous Cannulation and Blood Sampling in the Pediatric Emergency Department: A Prospective Quasi-Experimental Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Painful procedures such as intravenous cannulation and venous blood sampling are common in pediatric emergency departments and may lead to distress, anxiety, and negative healthcare experiences. Virtual reality (VR) has emerged as a non-pharmacological intervention that may reduce procedural pain through immersive distraction.
This prospective quasi-experimental study was conducted in a tertiary pediatric emergency department between September 2024 and September 2025. A total of 150 children aged 6-11 years requiring intravenous cannulation or venous blood sampling were included. Participants were enrolled sequentially, with 100 children assigned to the VR group and 50 to standard care. The VR intervention consisted of age-appropriate audiovisual content delivered through a VR headset during the procedure.
The primary outcome was procedure-related pain measured using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes included procedural duration, cooperation, first-attempt success, behavioral distress, parental satisfaction, and VR response. The study aimed to assess whether VR distraction may improve procedural experience and reduce procedure-related pain in pediatric emergency settings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Izmir, Turkey (Türkiye), 35100
- Ege University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Group
Children received age-appropriate audiovisual distraction through a virtual reality headset during intravenous cannulation or venous blood sampling procedures.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedure-related pain
Time Frame: Immediately after the procedure
|
Procedure-related pain assessed using the Wong-Baker FACES Pain Rating Scale (WBFPS) following intravenous cannulation or venous blood sampling.
|
Immediately after the procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGE-ETHICS-22-5.1T-33
- Project No: 32350 (Other Grant/Funding Number: Ege University Scientific Research Projects Coordination Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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