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Completed

NCT Number: NCT06112600

The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination

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.

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Key information

Conditions

Pain Fear Neurologic Manifestations Nursing Caries Pathological Conditions, Signs and Symptoms Pediatric Patient Signs and Symptoms Virtual Reality

Age range

48 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Bornova, 35040, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VR

Procedure

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

Kaleidoscope

Procedure

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

Primary outcomes

  1. Procedural Pain

    Time frame: 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.

  2. Fear

    Time frame: 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.

  3. Anxiety

    Time frame: 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 outcomes

  1. Parental satisfaction

    Time frame: 1 year

    parental satisfaction scores measured with the 10-point Likert type scale. Minimum score is 0, maximum score is 10.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2023
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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