The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination

NCT ID: NCT06112600

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-06-30

Brief Summary

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This study was designed to examine the effects of using virtual reality and kaleidoscope during routine vaccination in children aged 48 months on pain, fear, and anxiety. Children aged 48 months who were to receive the measles-mumps-rubella vaccine were randomized into three groups. Accordingly, the study sample consisted of a virtual reality group with 42 children, a kaleidoscope group with 42 children, and a control group with 42 children, totaling 126 children. Fear and pain were evaluated by both the researcher and the child before and after the procedure. Anxiety was assessed by the child after the procedure. The Wong Baker Faces Pain Rating Scale was used for pain, the Children's Fear Scale for fear, and the Child Anxiety Scale-State Version for anxiety.

Detailed Description

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Conditions

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Pain Pediatric Patient Fear Virtual Reality Nursing Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This prospective, randomised controlled study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

No attention-diverting method was applied to the children in this group and routine vaccination was administered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Virtual Reality group

The VR group received a VR application using the Oculus Quest 2 while being vaccinated.

Group Type EXPERIMENTAL

VR

Intervention Type PROCEDURE

Virtual reality glasses were used as a distraction method for children during vaccination.

Kaleidoscope group

In the Kaleidoscope group, children were given a kaleidoscope toy while being vaccinated.

Group Type EXPERIMENTAL

Kaleidoscope

Intervention Type PROCEDURE

Kaleidoscope toys were used as a distraction method for children during vaccination.

Interventions

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VR

Virtual reality glasses were used as a distraction method for children during vaccination.

Intervention Type PROCEDURE

Kaleidoscope

Kaleidoscope toys were used as a distraction method for children during vaccination.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* being 48 months
* being conscious (with the ability to communicate).

Exclusion Criteria

* Having a physical and psychological condition that prevents them from wearing glasses to view VR;
* Having a visual problem
* Having mental or physical disabilities
* Taking any analgesics, sedatives, or anticonvulsants in the past 24 hours
* Having chronic or life-threatening disease
* Refusing the VR or kaleidoscope intervention during vaccine injection.
Minimum Eligible Age

48 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Merve Gümüş

Research Assistant Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ege University

Izmir, Bornova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-79593712-799

Identifier Type: -

Identifier Source: org_study_id

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