The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination

Sponsor
Ege University (Other)
Overall Status
Completed
CT.gov ID
NCT06112600
Collaborator
(none)
126
1
3
21.5
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: VR
  • Procedure: Kaleidoscope
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This prospective, randomised controlled studyThis prospective, randomised controlled study
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Impact of Virtual Reality and Kaleidoscope Usage on Pain, Fear, and Anxiety in Children During Routine Vaccination: A Randomized Controlled Study
Actual Study Start Date :
Sep 15, 2021
Actual Primary Completion Date :
May 30, 2023
Actual Study Completion Date :
Jun 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  1. Parental satisfaction [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
48 Months to 48 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ege University İzmir Bornova Turkey 35040

Sponsors and Collaborators

  • Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merve Gümüş, Research Assistant Dr., Ege University
ClinicalTrials.gov Identifier:
NCT06112600
Other Study ID Numbers:
  • E-79593712-799
First Posted:
Nov 1, 2023
Last Update Posted:
Nov 1, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 1, 2023