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

NCT04755998 | Completed

• 1 other identifier: İlknur KAHRİMAN
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety and Fear

Keywords

Anxiety, Child, Fear, Vaccine, Virtual reality headset

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Other: Use of virtual reality glasses during vaccination applications in children

Control Group

NO INTERVENTION

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

Interventions

Use of virtual reality glasses during vaccination applications in children 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.

Experimental Group

Eligibility Criteria

• Age: 72 Months - 84 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

DIRECTORATE OF PROVINCIAL EDUCATION, and PROVINCIAL HEALTH DIRECTORATE

Ordu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• İlknur KAHRİMAN, Assoc. Prof.

  Karadeniz Technical University

  STUDY DIRECTOR

• Zila Ö KIRBAŞ, Master

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 16, 2021
• Study Start: September 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 12 months after publication
• Access Criteria: Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (1)