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

King Abdulaziz University

Status: Not yet enrolling

Conditions: Healthy; Behavior Management

Treatments: Device: Vibrating device; Procedure: Manual vibration

Study type: Interventional

Funder types: Other

Identifiers

NCT07306650

96-06-25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

22 participants in 2 patient groups

Device

Experimental group

Description:

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

Treatment:

Device: Vibrating device

Manual

Active Comparator group

Description:

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.

Treatment:

Procedure: Manual vibration