Virtual Reality Used During Tooth Extraction and Extirpation Treatment

NCT ID: NCT06315816

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Anxiety and Fear Tooth Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The data will be analyzed by a statistician blind to the groups.

Study Groups

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Experimantal

The children will ask to choose a three-dimensional cartoon from the list to watch during the procedure, it will run, the mobile phone will placed into the virtual reality glasses, and the children wear the VR glasses and start watching the cartoon. During the procedure, the children's parents and the researcher will present, and the children watch the cartoon through virtual reality glasses. After the procedure, the virtual reality glasses will removed, and ten minutes after the procedure will completed, the CFS and the CAS-S will apply as a post-test.

Group Type EXPERIMENTAL

virtual reality glasses used during tooth extraction and extirpation treatment

Intervention Type BEHAVIORAL

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

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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virtual reality glasses used during tooth extraction and extirpation treatment

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Murat Bektaş

OTHER

Sponsor Role lead

Responsible Party

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Murat Bektaş

Head of Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dilek Demir, PhD

Role: PRINCIPAL_INVESTIGATOR

Hakkari University

Locations

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Hakkari University

Hakkâri, Merkez, Turkey (Türkiye)

Site Status

Hakkari University

Hakkâri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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DokuzEU-1

Identifier Type: -

Identifier Source: org_study_id

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