- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06513260
Effect of Virtual Reality Distraction on Anxiety Control During Impacted Molar Tooth Surgery
Evaluation of the Effect of Virtual Reality Distraction on Controlling Dental Anxiety During the Surgical Extraction of Impacted Lower Third Molar Teeth
The goal of this clinical trial is to investigate the effectiveness of virtual reality distraction therapy using virtual reality glasses in reducing dental anxiety during the surgical extraction of impacted lower third molar teeth.The main questions it aims to answer are:
- Is the use of the virtual reality distraction during the procedure effective on perceived pain and anxiety?
- Evaluation of the effectiveness of the virtual reality distraction based on initial anxiety test scores.
- Does the use of the virtual reality headset cause difficulties for the clinician in performing the procedure?
Patients will undergo anxiety tests before surgery.
Pre-operative vital signs will be recorded.
The procedure will be performed either with or without virtual reality glasses, according to the randomly assigned groups.
Post-operative vital signs will be recorded.
At the end of the procedure, all patients will undergo anxiety tests and verbal rating scales.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Kütahya, Turkey (Türkiye), 43020
- Kutahya Health Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being over 18 years old
- Being systemically healthy
- Needing surgical extraction treatment of impacted lower third molar (in mesioangular position according to Tetsch and Wagner Classification)
- Having a score of 11 or higher on the dental anxiety scale
Exclusion Criteria:
- History of seizures or convulsive disorders
- Balance disorders such as nystagmus or vertigo
- Use of psychotropic medications
- Undergoing treatment for anxiety
- Patients with psychiatric disorders
- Presence of dermatological lesions, especially around the face and eyes
- Presence of any lesion in the eye that would prevent the use of virtual reality
- Presence of systemic diseases and medication use contraindicating surgical extraction of impacted teeth
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Virtual reality application
Application of virtual reality glasses during surgical extraction of impacted lower third molars.
|
Surgical extraction of impacted mandibular third molars in the mesioangular position, according to the Tetsch and Wagner classification
|
|
No application
No application of virtual reality glasses during surgical extraction of impacted lower third molars.
|
Surgical extraction of impacted mandibular third molars in the mesioangular position, according to the Tetsch and Wagner classification
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Dental Anxiety Scale Scores
Time Frame: Baseline
|
In patients with and without the use of virtual reality glasses, the dental anxiety scale and verbal rating scales evaluating their experience during the treatment will be applied.
|
Baseline
|
|
Heart rate measurements
Time Frame: During the operation
|
In patients with and without the use of virtual reality glasses, heart rate will be monitored before, during, and after the treatment.
|
During the operation
|
|
Blood pressure measurements
Time Frame: During the operation
|
In patients with and without the use of virtual reality glasses, blood pressure will be monitored before, during, and after the treatment.
|
During the operation
|
|
Oxygen saturation measurements
Time Frame: During the operation
|
In patients with and without the use of virtual reality glasses, saturation will be monitored before, during, and after the treatment.
|
During the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dentist feedback
Time Frame: Baseline
|
Verbal rating scales will be applied to the dentist to evaluate the potential difficulties associated with the use of virtual reality distraction.
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Eda İzgi, Kütahya University of Health Sciences
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KutahyaHSU/Edaİzgi/001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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