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

NCT07306650 | Not Yet Recruiting

• 1 other identifier: 96-06-25
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Behavior Management

Keywords

Vibrasthetic; Vibration; child behavior management; local anesthesia; pediatric dentistry

Outcome Measures

Primary Outcomes (3)

• Pain level

  Measured subjectively using an Arabic validated Wong-Baker Faces Pain Rating Scale by the participant choosing the picture that best describes the pain they felt. Minimum score is zero, maximum score is 10. Score of zero is the best outcome, which translates into "No hurt = no pain felt". Score of 10 is the worst outcome, which translates into "Hurts most = severe pain felt"

  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

  Measured objectively using Face, Legs, Activity, Cry, Consolability (FLACC) scale. The investigator monitoring the participant will record the participant's reaction while receiving the injection. Minimum score is zero, maximum score is 10. A score of zero is the best outcome, and a score of 10 is the worst outcome.

  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

  Measured using a pulse oxymeter placed on the participant's forefinger. Pulse rate will be recorded before the participant sits on the dental chair (while they are sitting on a chair next to the dental chair) to measure baseline heart rate. Then pulse rate will be recorded again immediately by the investigator monitoring the participant after the participant receives the injection.

  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 Outcomes (1)

• Behavior and cooperation

  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.

Study Arms (2)

Device

EXPERIMENTAL

This group will experience receiving a dental injection while the operator uses a vibrating device (Vibrasthetic) to vibrate the injection site.

Device: Vibrating device

Manual

ACTIVE COMPARATOR

Our study is a crossover study, so the participants will receive the dental injection while the operator manually vibrates their lip by holding the lip between their forefinger and thumb (control). The partcipants will be randomized, so phase I for the participants may be either the device or manual, and phase II will be the other method of vibration not used in phase I.

Procedure: Manual vibration

Interventions

Vibrating device 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.

Device

Manual vibration PROCEDURE

The operator will hold the participant's lip between their forefinger and thumb to manually vibrate the lip and hence vibrating the injection site.

Manual

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University Dental Hospital

Jeddah, Saudi Arabia

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

Study Officials

• Mariam B Aldajani

  King Abdulaziz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam B Aldajani, Master of Dental Science (MDS)

CONTACT

00966-567808848; maldajani@kau.edu.sa

Ghalia Y Bhadila

CONTACT

00966-503637670; gbhadila@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: December 26, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)