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

NCT ID: NCT04755998

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2019-12-31

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.

Conditions

Anxiety and Fear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

The Experimental Group watched cartoons with virtual reality glasses during vaccination applications.

Group Type: EXPERIMENTAL

Use of virtual reality glasses during vaccination applications in children

Intervention Type: OTHER

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.

Control Group

Pre-test and post-tests were applied to the non-intervention group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 72 Months
• Maximum Eligible Age: 84 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karadeniz Technical University

OTHER

Sponsor Role: lead

Responsible Party

İlknur KAHRİMAN

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İlknur KAHRİMAN, Assoc. Prof.

Role: STUDY_DIRECTOR

Karadeniz Technical University

Zila Ö KIRBAŞ, Master

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Locations

DIRECTORATE OF PROVINCIAL EDUCATION, and PROVINCIAL HEALTH DIRECTORATE

Ordu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

İlknur KAHRİMAN

Identifier Type: -

Identifier Source: org_study_id