- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06315816
Virtual Reality 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hakkari, Turkey
- Hakkari University
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Merkez
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Hakkari, Merkez, Turkey
- Hakkari University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No intervention
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|
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Experimental: 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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Means
Time Frame: 1-4 Weeks
|
Anxiety score will be measured with the Child Fear and Anxiety Scale.
The lowest score from the scale can be 0 and the highest score can be 10.
As the score obtained from the scale increases, the child's anxiety increases.
In this study, if children get high scores from the anxiety section of the scale, it will be determined that they have high procedural anxiety.
Getting a low score from the scale will indicate that their anxiety about the procedure is low.
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1-4 Weeks
|
|
Fear Means
Time Frame: 1-4 Weeks
|
Fear score will be measured with the Children's fear and anxiety scale.
The lowest score from the scale can be 0 and the highest score can be 10.
As the score obtained from the scale increases, the child's fear increases.
In this study, if children score high on the fear section of the scale, it will be determined that their fear of the procedure is high.
A low score on the scale will indicate that fears about the procedure are low.
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1-4 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dilek Demir, PhD, Hakkari University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DokuzEU-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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