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NCT Number: NCT07306650

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

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.

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Key information

Conditions

Healthy Behavior Management

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

    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"

  2. 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.

    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.

  3. 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.

    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.

Secondary outcomes

  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.

    Measured using Frankl behavior scale. The investigator monitoring the participant will record the participant's behavior during and after receiving the injection. Behavior can be scored as definitely negative (--), negative (-), positive (+), or definitely positive (++). A score of (--) is the worst outcome, and a score of (++) is the best outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghalia Y Bhadila

CONTACT

[email protected]

00966-503637670

Mariam B Aldajani, Master of Dental Science (MDS)

CONTACT

[email protected]

00966-567808848

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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