Virtual Reality Used During Tooth Extraction and Extirpation Treatment

Anxiety and Fear Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06315816
• Other study ID #: DokuzEU-1
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Dokuz Eylul University
• Contact: Dilek Demir Kösem, PhD
• Phone: +905534813290
• Email: dilekdemir624[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety and Fear
• Anxiety Disorders
• Tooth Disease
• Tooth Diseases

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Turkey	Hakkari University	Hakkari	Merkez
Turkey	Hakkari University	Hakkari

Sponsors (1)

Lead Sponsor	Collaborator
Murat Bektas

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Means	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.	1-4 Weeks
Primary	Fear Means	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.	1-4 Weeks