Effect of Vibrasthetic Device on Pain Reduction During Local Anesthesia in Pediatric Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorKing Abdulaziz University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Uncooperative children
Children with special healthcare needs
Children with conditions affecting pain perception
Trial design
Design model
Crossover
Treatments tested in this trial
Vibrating device
DeviceBattery 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/SurgeryThe operator will hold the participant's lip between their forefinger and thumb to manually vibrate the lip and hence vibrating the injection site.
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: DeviceExperimental treatment 1 intervention
Group B: ManualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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"
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.2
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.
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.3
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.
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 outcomes
1
Behavior and cooperation
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.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: