Effect of Vibrasthetic Device on Pain Reduction During Local Anesthesia in Pediatric Patients

Official title

Effect of Vibrasthetic Vibration Device on Pain Reduction During Local Anesthesia in Pediatric Patients: A Randomized Clinical Study

Overview

The goal of this clinical trial is to test if children aged between 6 and 14 years who are receiving a dental injection will feel less pain by using a vibration device applied to the injection site during the injection compared to vibrating the lip using only the researcher's hands without using the vibration device. It will also test if this device makes them feel less anxious during the injection. The main question it aims to answer is: Does using the Vibrasthetic device make dental injections more comfortable for children? Researchers will compare the effect of using this vibration device versus using their hands for manual vibration of the lip in the same child. Participants will: * Experience one method of vibration during their visit to the dentist (either the vibration device or manual vibration). * then after 2 weeks they will go to the same dentist again and experience the other method of vibration. * Receive the dental treatment they need in both visits. Participants will be asked to rate the pain they felt after the injection. This will be done by the participants choosing one of 6 pictures we will show them. Each picture explains the level of the pain they felt, and each picture has a score. We will score the pain the participants felt by looking at which picture they chose to describe their pain from the injection.

Detailed description

Each participant will start their dental appointment by them sitting on a chair beside the dental chair and having their heart rate recorded by a pulse oximeter for baseline comfort level. They will be randomly assigned to either receive the vibration using the Vibrasthetic vibration device or by the dentist researcher manually vibrating the participant's lip during the injection. Topical anesthesia will be applied on the injection site and then they will receive the dental injection along with experiencing vibration in the area of the dental injection administered. Immediately after the injection, the participant will rate the pain intensity felt during the injection using validated Pain Scale (Wong-Baker). During the injection, a separate researcher, called the monitor, will monitor the participant's pain using the FLACC scale (Face, Legs, Activity, Cry, Consolability). Also, the monitor will record the participant's behavior using the Frankl scale, after which the participant will receiver their needed dental treatment. In the following visit, the participant will receive the other vibration method before their dental treatment with the recording of the same metrics by the researchers.

Interventions

• Device Vibrating device
  Battery powered, no need to replace vibrating head of the unit (only a plastic barrier is required to cover the device), not investigated before.
• Procedure Manual vibration
  The operator will hold the participant's lip between their forefinger and thumb to manually vibrate the lip and hence vibrating the injection site.

Primary outcome measures

• Pain level [Time frame: Participant will record the level of pain felt immediately after receiving the injection. This usually occurs around 10 mins after the start of the appointment.]
• Pain level [Time frame: Participant pain will be recorded by the investigator monitoring the participant using the scale while the patient is receiving the injection. This usually occurs around 10 mins after the start of the appointment.]
• Pain level [Time frame: This metric will be measured from the start of the appointment until the participant receives the injection. This will usually take around 10 minutes.]

Secondary outcome measures (1)

• Behavior and cooperation [Time frame: This metric is measured by judging the participant's behavior, and is recorded after the injection is given. This will take around 10 mins from the start of the appointment.]

Eligibility criteria

Inclusion criteria

• Children aged 6-14 years
• who have previously received local anesthesia
• and whose behavior, according to the Frankl scale, was positive or definitely positive
• and the absence of systemic diseases or known allergies to local anesthetic agents

Exclusion criteria

• Uncooperative children
• Children with special healthcare needs
• Children with conditions affecting pain perception

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Supportive care

Study locations

Saudi Arabia · 1 center

• King Abdulaziz University Dental Hospital — Jeddah

Publications

• Ching D, Finkelman M, Loo CY. Effect of the DentalVibe injection system on pain during local anesthesia injections in adolescent patients. Pediatr Dent. 2014 Jan-Feb;36(1):51-5. PMID 24717710
• Oliveira MA, Bendo CB, Ferreira MC, Paiva SM, Vale MP, Serra-Negra JM. Association between childhood dental experiences and dental fear among dental, psychology and mathematics undergraduates in Brazil. Int J Environ Res Public Health. 2012 Dec 17;9(12):4676-87. doi: 10.3390/ijerph9124676. PMID 23247225
• Kadam, N. S., Hegde, A. M., & Sharma, A. (2024). Comparative evaluation of anxiety levels in children using distraction techniques: An assessment with Venham Picture Test and pulse oximeter. Journal of Scientific Dentistry, 12(2), 95-101

Identifiers

NCT: NCT07306650 · 96-06-25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗