The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination

Study Overview
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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.

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

Conditions
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Pain, Pediatric Patient, Fear, Virtual Reality, Nursing Caries

Intervention / Treatment
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* Procedure: VR
* Procedure: Kaleidoscope


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 48 Months
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This prospective, randomised controlled study
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |