The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination

Not Applicable

Completed

• Conditions: Virtual Reality; Pediatric Patient; Fear; Nursing Caries; Pain
• Interventions: Procedure: Kaleidoscope; Procedure: VR

• Registration Number: NCT06112600
• Lead Sponsor: Ege University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-15
• Primary Completion: 2023-05-30
• Study Completion: 2023-06-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kaleidoscope group	Kaleidoscope	In the Kaleidoscope group, children were given a kaleidoscope toy while being vaccinated.
Virtual Reality group	VR	The VR group received a VR application using the Oculus Quest 2 while being vaccinated.

Primary Outcome Measures

Name	Time	Method
Procedural Pain	1 year	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.
Fear	1 year	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.
Anxiety	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Parental satisfaction	1 year	parental satisfaction scores measured with the 10-point Likert type scale. Minimum score is 0, maximum score is 10.

Trial Locations

Locations (1)

Ege University; 🇹🇷 İzmir, Bornova, Turkey