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

Primary Purpose

Anxiety and Fear

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Use of virtual reality glasses during vaccination applications in children
Sponsored by
Karadeniz Technical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety and Fear focused on measuring Anxiety, Child, Fear, Vaccine, Virtual reality headset

Eligibility Criteria

72 Months - 84 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • DIRECTORATE OF PROVINCIAL EDUCATION, and PROVINCIAL HEALTH DIRECTORATE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 13, 2021
Last Updated
February 15, 2021
Sponsor
Karadeniz Technical University
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1. Study Identification

Unique Protocol Identification Number
NCT04755998
Brief Title
Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations
Official Title
Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations on Children's Fear and Anxiety Levels
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karadeniz Technical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety and Fear
Keywords
Anxiety, Child, Fear, Vaccine, Virtual reality headset

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The Experimental Group watched cartoons with virtual reality glasses during vaccination applications.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Pre-test and post-tests were applied to the non-intervention group
Intervention Type
Other
Intervention Name(s)
Use of virtual reality glasses during vaccination applications in children
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Child Fear Scale
Description
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.
Time Frame
with an average interval of three to five minutes
Title
The Children's Anxiety Scale-State Scale
Description
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.
Time Frame
with an average interval of three to five minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
72 Months
Maximum Age & Unit of Time
84 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İlknur KAHRİMAN, Assoc. Prof.
Organizational Affiliation
Karadeniz Technical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zila Ö KIRBAŞ, Master
Organizational Affiliation
Karadeniz Technical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DIRECTORATE OF PROVINCIAL EDUCATION, and PROVINCIAL HEALTH DIRECTORATE
City
Ordu
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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