Virtual Reality Used During Tooth Extraction and Extirpation Treatment

NCT06315816 | Completed

• 1 other identifier: DokuzEU-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety and Fear; Tooth Disease

Keywords

Tooth extraction; Extirpation; Child; Anxiety; fear; Nursing; virtual reality

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Experimantal

EXPERIMENTAL

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.

Behavioral: virtual reality glasses used during tooth extraction and extirpation treatment

Control

NO INTERVENTION

No intervention

Interventions

virtual reality glasses used during tooth extraction and extirpation treatment 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

Experimantal

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Murat Bektaş: lead

Study Sites (2)

Hakkari University

Hakkâri, Merkez, Turkey (Türkiye)

Location

Hakkari University

Hakkâri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Tooth Diseases

Condition Hierarchy (Ancestors)

Mental Disorders; Stomatognathic Diseases

Study Officials

• Dilek Demir, PhD

  Hakkari University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data will be analyzed by a statistician blind to the groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: March 18, 2024
• Study Start: April 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 30, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: When study will finish, study protocol will share
• Access Criteria: It will be shared by the authors.

Locations

TU (2)