The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06112600
• Other study ID #: E-79593712-799
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: June 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Months to 48 Months

Eligibility

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.

Related Conditions & MeSH terms

• Fear
• Nursing Caries
• Pain
• Pediatric Patient
• Virtual Reality

Intervention

Procedure:
• VR
Virtual reality glasses were used as a distraction method for children during vaccination.
• Kaleidoscope
Kaleidoscope toys were used as a distraction method for children during vaccination.

Locations

Country	Name	City	State
Turkey	Ege University	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Parental satisfaction	parental satisfaction scores measured with the 10-point Likert type scale. Minimum score is 0, maximum score is 10.	1 year