Virtual Reality and Laser Biostimulation on Pain Perception and Dental Anxiety

Effect of Virtual Reality and Laser Biostimulation on Pain Perception and Dental Anxiety in Children

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.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety; Pain Intensity Assessment
• Intervention / Treatment: Other: Tell Show Do Group + LLLT; Other: Tell Show Do Group; Other: Distraction with Virtual reality glassess + LLLT; Other: Distraction with Virtual reality glassess

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Marmara
    • Istanbul, Marmara, Turkey, 34147
      • Altinbas University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group IIa Tell- Show-Do; Placebo topical anesthesia + LLLT + Local anesthesia	Other: Tell Show Do Group + LLLT; The injection site was dried with a cotton pellet and placebo topical anaesthesia was applied with a pre-sterilised wooden ear stick in a circular motion followed by laser biostimulation. The Wiser diode laser (Doctor Smile, Vicenza, Italy), a diode laser device with a wavelength of 980 nm and equipped with a 600 μm diameter fibre, was used to deliver low-level laser therapy to the area of interest. The tip of the laser carrier system was placed at a distance of 1 cm from the target tissue without contact and applied with continuous circular movements as recommended by the manufacturer. A silicone piece was placed on the end of the carrier system to ensure that the distance to the tissue remained constant in each application. The focal spot area was determined as 0.087 cm2. The power of the laser used in our study was determined as 0.3 W and the application time was selected as 60 seconds. During the whole procedure, the patient wore virtual glasses and the physician wore protective go; Other: Tell Show Do Group; In this session, the injection area was dried with a cotton pellet before injection. A topical anaesthetic gel containing 20% benzocaine (Vision pat gel) was applied to the mucosal tissues to be injected using a pre-sterilised ear stick. After the application of the topical anaesthetic agent, the laser device was positioned in the same way, but without applying energy, and the sound of the laser device was pre-recorded and the study was blinded. In this way, a placebo effect was created and the patient was prevented from distinguishing between the laser and non-laser session. After this procedure, local anaesthesia was applied.; Other Names: Group IIb
Placebo Comparator: Group IIb Tell- Show-Do; Topical anesthesia + placebo LLLT + Local anesthesia	Other: Tell Show Do Group; In this session, the injection area was dried with a cotton pellet before injection. A topical anaesthetic gel containing 20% benzocaine (Vision pat gel) was applied to the mucosal tissues to be injected using a pre-sterilised ear stick. After the application of the topical anaesthetic agent, the laser device was positioned in the same way, but without applying energy, and the sound of the laser device was pre-recorded and the study was blinded. In this way, a placebo effect was created and the patient was prevented from distinguishing between the laser and non-laser session. After this procedure, local anaesthesia was applied.; Other Names: Group IIb
Active Comparator: Group Ia Distraction (VR); Placebo topical anesthesia + LLLT + Local anesthesia	Other: Distraction with Virtual reality glassess + LLLT; The injection area was dried with a cotton pellet before injection. A topical anaesthetic gel containing 20% benzocaine (Vision pat gel) was applied to the mucosal tissues to be injected using a pre-sterilised ear stick. After the application of the topical anaesthetic agent, the laser device was positioned in the same way, but without applying energy, and the sound of the laser device was pre-recorded and the study was blinded. In this way, a placebo effect was created and the patient was prevented from distinguishing between the laser and non-laser session. After this procedure, local anaesthesia was applied.
Placebo Comparator: Grup Ib Distraction (VR); Topical anesthesia + placebo LLLT + Local anesthesia	Other: Distraction with Virtual reality glassess; the injection site was dried with a cotton pellet and placebo topical anaesthesia was applied with a pre-sterilised wooden ear stick in a circular motion followed by laser biostimulation. The Wiser diode laser (Doctor Smile, Vicenza, Italy), a diode laser device with a wavelength of 980 nm and equipped with a 600 μm diameter fibre, was used to deliver low-level laser therapy to the area of interest. The tip of the laser carrier system was placed at a distance of 1 cm from the target tissue without contact and applied with continuous circular movements as recommended by the manufacturer. A silicone piece was placed on the end of the carrier system to ensure that the distance to the tissue remained constant in each application. The focal spot area was determined as 0.087 cm2. The power of the laser used in our study was determined as 0.3 W and the application time was selected as 60 seconds. The patient and the physician wore protective goggles during the whole procedure to prevent possi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception	In this study, each patient received both topical anaesthesia and DSLT treatment using a split-mouth design.Pain perception was measured by Wong and Baker scale. In this scale there are 6 different facial expressions ranging from very happy to very unhappy to express the level of pain.The scale includes six faces, each illustrating a different level of pain intensity: 0 (No Pain), 1 (Very Mild Pain), 2 (Mild Pain), 3 (Moderate Pain), 4 (Severe Pain) 5 (Very Very Severe Pain). The Wong Baker facial expression pain scale was evaluated right before and immediately after the application of local anesthesia by an observer physician other than the physician administering local anesthesia. The pictures on this scale were introduced to the patient in an appropriate language. Right before and immediately after local anesthetic injection, the picture chosen by the patient was recorded on the scale.	Right before and immediately after treatment
Dental Anxiety	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).	Right before and immediately after treatment
Pain perception	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.	During local anesthesia application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Anxiety	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.	Right before, during and immediately after the application of local anesthesia

Collaborators and Investigators

• Sponsor: SIRIN GUNER ONUR
• Investigators: Study Director: SIRIN GUNER ONUR, PhD

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: children; dental anxiety; virtual reality; pain perception; dental laser
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pain; Anxiety Disorders
• Other Study ID Numbers: 2022/143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No