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

Sponsor
Karadeniz Technical University (Other)
Overall Status
Completed
CT.gov ID
NCT04755998
Collaborator
(none)
169
1
2
4
42.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Use of virtual reality glasses during vaccination applications in children
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
169 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations on Children's Fear and Anxiety Levels
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
72 Months to 84 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 DIRECTORATE OF PROVINCIAL EDUCATION, and PROVINCIAL HEALTH DIRECTORATE Ordu Turkey

Sponsors and Collaborators

  • Karadeniz Technical University

Investigators

  • Study Director: İlknur KAHRİMAN, Assoc. Prof., Karadeniz Technical University
  • Principal Investigator: Zila Ö KIRBAŞ, Master, Karadeniz Technical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
İlknur KAHRİMAN, Assoc. Prof., Karadeniz Technical University
ClinicalTrials.gov Identifier:
NCT04755998
Other Study ID Numbers:
  • İlknur KAHRİMAN
First Posted:
Feb 16, 2021
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by İlknur KAHRİMAN, Assoc. Prof., Karadeniz Technical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2021