Clinical trial NCT04755998: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety and Fear
Keywords: Anxiety, Child, Fear, Vaccine, Virtual reality headset
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 169
Sex: ALL
Minimum age (years): 72
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The Child Fear Scale
timeFrame: with an average interval of three to five minutes
measure: The Children's Anxiety Scale-State Scale
timeFrame: with an average interval of three to five minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: DIRECTORATE OF PROVINCIAL EDUCATION, and PROVINCIAL HEALTH DIRECTORATE
Study officials:
affiliation: Karadeniz Technical University
name: İlknur KAHRİMAN, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Karadeniz Technical University
name: Zila Ö KIRBAŞ, Master
role: PRINCIPAL_INVESTIGATOR
References: