Virtual Reality and Laser Biostimulation on Pain Perception and Dental Anxiety

Not Applicable

Completed

• Conditions: Dental Anxiety; Pain Intensity Assessment

• Registration Number: NCT06698562
• Lead Sponsor: SIRIN GUNER ONUR

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

Study Timeline

• Study Start: 2023-01-03
• Primary Completion: 2023-04-25
• Study Completion: 2023-05-15
• Status Verified: 2024-11
• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain perception	During local anesthesia application	The "Face, Legs, Activity, Cry, Consolability (FLACC)" pain assessment scale was also evaluated during local anesthesia application by an observer clinician other than the clinician to whom local anesthesia would be applied. The patient's reactions were evaluated by observation by the researcher. Pain values were determined between 0-2 for each parameter and 0-10 for the total scale score. According to the scale, the total score was evaluated as follows: 0: No pain, 1-3: Mild pain, 4-6: Moderate pain and discomfort, 7-10: Severe pain and discomfort.
Dental Anxiety	Right before and immediately after treatment	Dental anxiety levels of the children were physiologically evaluated using the 'Venham Picture Test'. The picture chosen by the patient was recorded on the scale. The Venham Picture Test was assessed right before and immediately after local anaesthetic injection by an observer clinician other than the clinician administering the local anesthesia. The children were shown 8 pairs of pictures of boys (one "anxious" picture and one "non-anxious" picture), each drawn in a contrasting mood, and were asked to choose the picture on each card that corresponded to their feelings. A score of 1 was given if the child chose the "anxious" picture and 0 if the child chose the "non-anxious" picture. To determine the total score, the number of "anxious" pictures was summed (lowest score 0, highest score 8).

Secondary Outcome Measures

Name	Time	Method
Dental Anxiety	Right before, during and immediately after the application of local anesthesia	Pulse rate and oxygen saturation values were measured with a pulse oximetry device. The measurement was started by attaching the finger apparatus of the device to the index finger of the left hand of the patients. Then, the pulse and SpO2 values right before, during and immediately after the application of local anesthesia were recorded. At the end of the session, these values were averaged and recorded in the case report form.

Trial Locations

Locations (1)

Altinbas University Faculty of Dentistry; 🇹🇷 Istanbul, Marmara, Turkey