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

Not Applicable

Completed

• Conditions: Anxiety and Fear
• Interventions: Other: Use of virtual reality glasses during vaccination applications in children

• Registration Number: NCT04755998
• Lead Sponsor: Karadeniz Technical University

Brief Summary

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.

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 Timeline

• Study Start: 2019-09-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-02
• Study First Submitted: 2021-02-13
• Study First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-15
• Study First Posted: 2021-02-16
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Use of virtual reality glasses during vaccination applications in children	The Experimental Group watched cartoons with virtual reality glasses during vaccination applications.

Primary Outcome Measures

Name	Time	Method
The Child Fear Scale	with an average interval of three to five minutes	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.
The Children's Anxiety Scale-State Scale	with an average interval of three to five minutes	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.

Trial Locations

Locations (1)

DIRECTORATE OF PROVINCIAL EDUCATION, and PROVINCIAL HEALTH DIRECTORATE; 🇹🇷 Ordu, Turkey