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Completed

NCT Number: NCT04755998

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

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.

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Key information

Conditions

Anxiety and Fear Anxiety Disorders Mental Disorders

Age range

72 month–84 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DIRECTORATE OF PROVINCIAL EDUCATION, and PROVINCIAL HEALTH DIRECTORATE

Ordu, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The Child Fear Scale

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations on Children's Fear and Anxiety Levels

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 16, 2021
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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