Clinical trial NCT06698562: Virtual Reality and Laser Biostimulation on Pain Perception and Dental Anxiety
Official title: Effect of Virtual Reality and Laser Biostimulation on Pain Perception and Dental Anxiety in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Pain Intensity Assessment
Keywords: pain perception
dental anxiety
children
virtual reality
dental laser
Lead sponsor: Altinbas University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study included 40 Frankl "positive" and "definitely positive" pediatric patients between the ages of 6 and 10, applied to Altinbaş University Faculty of Dentistry Pediatric Dentistry Clinic for routine dental treatments between January 2023 and April 2023, and had no previous local anesthesia experience.

This study designed as a randomized, single-center, split-mouth, double blind clinical trial.
Primary purpose: TREATMENT

Brief summary: Dental anxiety in children can prevent planned treatment from being carried out, negatively affect the child's relationship with the dentist and make the treatment process difficult. The most common sources of directly anticipated anxiety are known to be associated with pain. Painful experiences are anxiety-provoking for people of all ages, especially children.This study aims to evaluate the effect of virtual reality glassess (VR) and low-level laser therapy (LLLT) on dental anxiety and pain perception during local anaesthesia administration in paediatric patients.

Detailed description: This study aims to investigate the combined effects of virtual reality glassess (VR) and low-level laser therapy (LLLT) on dental anxiety and pain perception in paediatric patients undergoing local anaesthesia for dental procedures. Dental anxiety is a common issue in children, often leading to increased pain perception and poor cooperation during treatment. Virtual reality has been proposed as a distraction technique, while LLLT is believed to reduce pain and inflammation. By exploring the effectiveness of these two interventions, the study seeks to determine whether VR and LLLT can serve as effective adjuncts to improve patient comfort, reduce anxiety, and enhance overall treatment experience during the administration of local anaesthesia

Eligibility criteria: Inclusion Criteria:

* No history of systemic disease or infectious disease
* Compliant with the dental treatments to be performed in the Children's Dental Hospital and able to answer the questions asked
* Exhibiting 'positive' and 'absolutely positive' behaviours during the examination, compliant according to the Frankl scale,
* Children with no previous experience of dental treatment with local anaesthesia

Exclusion Criteria:

* Children with any systemic condition
* Mentally and physically disabled, unable to co-operate,
* Children allergic to local anaesthesia,
* Previous dental treatment experience with local anaesthesia
* Exhibiting "negative" and "strongly negative" behaviour according to the Frankl scale
* Children with eye diseases such as myopia and astigmatism

Primary outcomes:
measure: Pain perception
timeFrame: Right before and immediately after treatment
measure: Dental Anxiety
timeFrame: Right before and immediately after treatment
measure: Pain perception
timeFrame: During local anesthesia application
Secondary outcomes:
measure: Dental Anxiety
timeFrame: Right before, during and immediately after the application of local anesthesia
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Altinbas University Faculty of Dentistry
state: Marmara
Study officials:
name: SIRIN GUNER ONUR, PhD
role: STUDY_DIRECTOR
References: