Clinical trial NCT06315816: Virtual Reality Used During Tooth Extraction and Extirpation Treatment
Official title: The Effect of Virtual Reality Glasses Used During Tooth Extraction and Extirpation Treatment Under Local Anesthesia on Anxiety and Fear in 7-10 Years Old Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety and Fear
Tooth Disease
Keywords: Tooth extraction
Extirpation
Child
Anxiety
fear
Nursing
virtual reality
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The population will consist of children between the ages of 7-10 who presented to the pediatric dental clinic of an oral and dental health center Turkey. The sample size of the study was calculated as GPOWER 3.1 statistical analysis software, based on a significance level of 0.05, a power value of 80%, and an effect size of 0.15 (medium effect size). Considering 10% attrition, it will plan to sample a total of 80 children, including 40 in the experimental group and 40 in the control group. Eventually, a total of 120 children, 60 in the experimental group and 60 in the control group,will include in the study to reveal the relationship between the variables more clearly.
Primary purpose: PREVENTION

Brief summary: This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years.

Detailed description: Aims and Objectives: Virtual reality glasses can be used as a distraction method in dental practices for children. This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years.

Design: A randomized controlled experimental study design will use. Methods: The sample of the study consisted of 120 seven to ten-year-old children, including 60 in the experimental group and 60 in the control group, who will receive tooth extraction and extirpation treatment in the pediatric dental clinic of an oral and dental health center. Data collection tools included a Child and Family Information Form, the Children's Fear Scale, and the Child Anxiety Scale-State. During the procedure, the children in the experimental group will watch a video that they chose through virtual reality glasses. No intervention will apply to the control group. Data will analyz using the Chi-square test, t-test, Shapiro-Wilk, mean, and percentage distributions.

Eligibility criteria: Inclusion Criteria:

* Children who will between the ages of 7-10,
* Children who have Tooth Extraction
* Children who have Extirpation Treatment
* Have no cognitive development problems,

Exclusion Criteria:

* Children who will not want to participate in the study,
* Leave the research during the study,
* Have an audio-visual disorder that could prevent the use of virtual glasses.

Primary outcomes:
measure: Anxiety Means
timeFrame: 1-4 Weeks
measure: Fear Means
timeFrame: 1-4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hakkari
country: Turkey
facility: Hakkari University
state: Merkez
city: Hakkari
country: Turkey
facility: Hakkari University
Study officials:
affiliation: Hakkari University
name: Dilek Demir, PhD
role: PRINCIPAL_INVESTIGATOR
References: