NCT06112600

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

October 23, 2023

Last Update Submit

October 27, 2023

Conditions

PainPediatric PatientFearVirtual RealityNursing Caries

Outcome Measures

Primary Outcomes (3)

  • Procedural Pain

    Just before vaccination, both the child and the researcher used the Wong-Baker Faces Scale. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/no pain) to crying (10 = hurts worst). The child can choose the face that best illustrates the physical pain.

    1 year

  • Fear

    Just before vaccination, both the child and the researcher used the Children's Fear Scale. The scale includes five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) and has been validated for the Turkish population The scale allows for evaluations on a scale from 0 to 4.

    1 year

  • Anxiety

    Just before vaccination, both the child and the researcher used the Children's Anxiety Meter-State. It is drawn like a thermometer with a bulb at the bottom. It includes horizontal lines going up to the top (0-10). Children are asked to mark how feel "right now" to measure state anxiety. Higher values represent higher anxiety.

    1 year

Secondary Outcomes (1)

  • Parental satisfaction

    1 year

Study Arms (3)

Control Group

NO INTERVENTION

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

Virtual Reality group

EXPERIMENTAL

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

Procedure: VR

Kaleidoscope group

EXPERIMENTAL

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

Procedure: Kaleidoscope

Interventions

VRPROCEDURE

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

Virtual Reality group
KaleidoscopePROCEDURE

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

Kaleidoscope group

Eligibility Criteria

Age48 Months - 48 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This prospective, randomised controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Dr.

Study Record Dates

First Submitted

October 23, 2023

First Posted

November 1, 2023

Study Start

September 15, 2021

Primary Completion

May 30, 2023

Study Completion

June 30, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations

TU(1)