Active Virtual Reality Distraction on Procedure-Related Emotional Behaviour, Pain, And Anxiety (Oculus2)

Active Virtual Reality Distraction on Procedure-Related Emotional Behaviour, Pain, And Anxiety During Venipuncture

This study aimed to evaluate the effect of virtual reality methods on procedure-related emotional behaviour, pain, and anxiety levels in school-age children undergoing venipuncture.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety State; Venipuncture
• Intervention / Treatment: Device: active VR distraction; Device: passive VR distraction

Detailed Description

Participants were assigned to three groups through stratified randomization: the active VR, the passive VR, and the control group. Children in the VR groups wore VR goggles (Oculus Quest 2) during venipuncture.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye), 35100
    • Dokuz Eylül University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The child agrees to participate in the study voluntarily.
• The parent agrees to participate in the study voluntarily.
• Obtaining consent forms from the child and parent

Exclusion Criteria:

• The child has a physical and psychological deficit that will prevent him from wearing the glasses that will be placed on his head to watch virtual reality.
• Having fever (>37.5C) and severe dehydration
• The patient did not take analgesics before the intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standart care
Experimental: Active VR; The remote control of the virtual glasses will be given to the hand that will not be interfered with, and the child will start, slow down or stop the application herself. Samsung Gear Oculus Guest 2 headset allows watching virtual reality applications.	Device: active VR distraction; The remote control of the virtual glasses will be given to the hand, and the child will start, slow down or stop the application herself.
Experimental: Passive VR; It was said that he could watch videos by wearing virtual headset glasses during the procedure. A virtual reality application with Oculus Guest 2 that will attract the attention of children was determined by the researchers.	Device: passive VR distraction; watching the application by wearing virtual glasses with Oculus Guest 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
procedure related pain	Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).	3 minutes after the phlebotomy
procedure related anxiety	The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety	3 minutes after the phlebotomy
procedure related emotional apperance	This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors	immediately after the phlebotomy

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Principal Investigator: Gülçin Özalp Gerçeker, Prof., Dokuz Eylül University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: VRdeuOculus2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No