The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination

The Impact of Virtual Reality and Kaleidoscope Usage on Pain, Fear, and Anxiety in Children During Routine Vaccination: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Pain; Fear; Virtual Reality; Nursing Caries; Pediatric Patient
• Intervention / Treatment: Procedure: VR; Procedure: Kaleidoscope

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İzmir, Bornova, Turkey, 35040
      • Ege University

Participation Criteria

Eligibility Criteria

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

Description

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.

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 Group; No attention-diverting method was applied to the children in this group and routine vaccination was administered.
Experimental: Virtual Reality group; The VR group received a VR application using the Oculus Quest 2 while being vaccinated.	Procedure: VR; Virtual reality glasses were used as a distraction method for children during vaccination.
Experimental: Kaleidoscope group; In the Kaleidoscope group, children were given a kaleidoscope toy while being vaccinated.	Procedure: Kaleidoscope; Kaleidoscope toys were used as a distraction method for children during vaccination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental satisfaction	parental satisfaction scores measured with the 10-point Likert type scale. Minimum score is 0, maximum score is 10.	1 year

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: E-79593712-799

Drug and device information, study documents

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