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

NCT07261410 | Completed

• 1 other identifier: VRdeuOculus2
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Anxiety State; Venipuncture

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Control

NO INTERVENTION

Standart care

Active VR

EXPERIMENTAL

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

Passive VR

EXPERIMENTAL

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

Interventions

active VR distraction DEVICE

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.

Active VR

passive VR distraction DEVICE

watching the application by wearing virtual glasses with Oculus Guest 2

Passive VR

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Gülçin Özalp Gerçeker, Prof.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor, Pediatric Nursing Department

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: January 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)