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

NCT07306650 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-01-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • King Abdulaziz University

    lead OTHER

Principal Investigators

  • Mariam B Aldajani · King Abdulaziz University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-26
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306650 on ClinicalTrials.gov