Effect of Using Virtual Reality Goggles on Fear and Pain Level During Vaccination in Children

NCT06560320 | Completed

• 1 other identifier: GO 2024/176
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using Virtual Reality Glasses reducing fear and pain during routine vaccination in children.

Conditions

Fear of Pain; Fear; Virtual Reality; Pain; Vaccination; Children

Keywords

fear; Pain; Virtual Reality; Vaccination; Child; Children

Outcome Measures

Primary Outcomes (2)

• Children's Fear Scale

  CFS is used for measuring the child's anxiety level. CFS is a scale which makes an evaluation from 0 to 4 consisting of five facial expressions drawn to show expressions that vary from neutral expression (0=no anxiety) to scared face (4=severe anxiety).

  Through painful procedure completion, an average of 10 minutes

• Wong-Baker FACES Pain Rating Scale

  In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.

  Through painful procedure completion, an average of 10 minutes

Study Arms (2)

Virtual Reality Glasses Group

EXPERIMENTAL

Virtual Reality (VR) Glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses before starting the application and it continued until the end of vaccination procedure.

Behavioral: Virtual Reality Glasses

Control group

NO INTERVENTION

In this group, children received routine vaccination procedure.

Interventions

Virtual Reality Glasses BEHAVIORAL

Virtual Reality(VR) Glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses before starting the application and it continued until the end of the vaccination procedure.

Virtual Reality Glasses Group

Eligibility Criteria

• Age: 48 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children the ages of 48 months,
• Volunteering of the child and parent to participate in the study,
• Healthy children,
• Vaccination should be done by the same nurse,

You may not qualify if:

• The child has any acute or chronic disease,
• The child has a mental disability, vision, speech or communication problems,
• The parent has hearing, vision or verbal communication difficulties,
• The child used analgesics in the last 6 hours,
• Infection, disruption of skin integrity and rash in the area where the application will be made,

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Burdur Bucak

Burdur, Bucak, 15030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Selda Ateş Beşirik

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This prospective, randomised controlled study.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: April 1, 2024
• Primary Completion: February 10, 2025
• Study Completion: March 15, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)