Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations

Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations on Children's Fear and Anxiety Levels

This study was conducted with a randomized controlled experimental design to determine the effect of virtual reality headset on children's fear and anxiety during vaccinations.

Research Hypotheses:

Hypothesis 0a (H0a): There is no difference in fear scores between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.

Hypothesis 1a (H1a): There is a difference in fear scores between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.

Hypothesis 0b (H0b): There is no difference in anxiety scores between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.

Hypothesis 1b (H1b): There is a difference in anxiety scores experienced between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.

Study Overview

• Status: Completed
• Conditions: Anxiety and Fear
• Intervention / Treatment: Other: Use of virtual reality glasses during vaccination applications in children

Detailed Description

Interventions made for protecting health or curing diseases, significantly affect children's psychological state and social adaptation. Being one of these interventions, vaccination may cause fear and anxiety in children. This fear and anxiety may affect children's future treatment and care experiences and result in fright and avoidance in them. Thus, it is important to try and reduce biological stress and to cope with psychosocial stress. One of the methods which can be used for this purpose is virtual reality headset used as a distraction method. This study was conducted with a randomized controlled experimental design to determine the effect of virtual reality headset on children's fear and anxiety during vaccinations. The population of the study consisted of first grade students attending primary schools in the city center of Ordu. The study was completed with 84 students in the experimental group and 85 students in the control group. With the sample number obtained as a result of the study, the test power was found to be 89.8% when the alpha error was 0.05 and the effect size was kept at 0.5. The data were collected using the Child and Parent Introductory Information Form, Children's Fear Scale, and Children's Anxiety Scale-State Scale.

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ordu, Turkey
    • DIRECTORATE OF PROVINCIAL EDUCATION, and PROVINCIAL HEALTH DIRECTORATE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 7 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parental consent
• Student's willingness to participate in the research
• The student does not have a mental or neurological disability
• Not being able to communicate
• The student does not have a chronic illness
• The student does not have an illness that causes acute or chronic pain
• The student has not used any analgesic medication in the last 24 hours.

Exclusion Criteria:

• Lack of parental consent
• Student's unwillingness to participate in the research
• The student has a mental or neurological disability
• The student has a communication disability
• The student has a chronic illness
• The student has an illness that causes acute or chronic pain
• The student's use of medication that will have an analgesic effect in the last 24 hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Group; The Experimental Group watched cartoons with virtual reality glasses during vaccination applications.	Other: Use of virtual reality glasses during vaccination applications in children; To the experimental group: Before the vaccine administration; Children's Fear Scale, and Children's Anxiety Scale-State Scale was applied to the student.; Cartoons and virtual reality glasses that the student wanted to watch were prepared.; While the nurse was preparing the vaccines, the student was put on virtual reality glasses and the distance settings of the lenses were adjusted and the cartoons he chose to watch during the vaccination applications started to be shown. Since virtual reality glasses can cause anxiety attacks manifested by nausea in some children, this was also tested beforehand. It took about two minutes to administer the vaccine and watch cartoons. Those applied after the vaccine administration; - Children's Fear Scale, and Children's Anxiety Scale-State Scale was applied to the student.
NO_INTERVENTION: Control Group; Pre-test and post-tests were applied to the non-intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Child Fear Scale	This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. It can be used for children aged 5-10 years.	with an average interval of three to five minutes
The Children's Anxiety Scale-State Scale	It assesses children's anxiety in clinical settings and uses before medical procedures. The Children's Anxiety Scale-State Scale is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety. Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.	with an average interval of three to five minutes

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Study Director: Ilknur Kahriman, Assoc. Prof., Karadeniz Technical University; Principal Investigator: Zila Ö KIRBAŞ, Master, Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: February 13, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (ACTUAL): February 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Anxiety, Child, Fear, Vaccine, Virtual reality headset
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: İlknur KAHRİMAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: 12 months after publication
• IPD Sharing Access Criteria: Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No