Actively Recruiting
Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception During Needle Insertion in Children
Led by Alexandria University · Updated on 2025-02-24
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how different methods of pain control affect children's pain perception during local anesthesia injections. The study focuses on healthy children aged 5 to 9 years undergoing simple restorative dental procedures. It compares the use of the Buzzy device in two ways: vibration mode without a cold pack and cold pack without vibration, against the standard topical anesthetic gel. The goal is to see which method better reduces pain and anxiety during the needle insertion. The study includes three groups: one receiving topical anesthetic gel applied to numb the injection site, another using vibration from the Buzzy device placed outside the mouth during needle insertion, and a third using the cold pack from the Buzzy device without vibration. All treatments are applied before and during the injection. Participants are randomly assigned to one of these groups to compare their pain responses. During the procedure, pain perception is measured using the SEM scale while the needle is inserted. Immediately after, pain is also assessed with a Visual Analog Scale (VAS). Parents provide consent for participation, and children with cooperative behavior are included. The study collects data on pain levels and behavior to evaluate how each method influences pain relief in children during dental anesthesia.
CONDITIONS
Brief Title
Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients indicated for simple restorative procedures
- Children with physical status ASA I or II
- Children with no learning disabilities
- Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale
- Patients whose parents will give consent to participate
You will not qualify if you...
- Patients allergic to local anesthesia or having a family history of allergy to local anesthesia
- Patients with acute oral or facial infection (swelling and/or cellulitis)
- Having active sites of pathosis in the area of injection that could affect anesthetic assessment
- Children with special health care needs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure day
Participants receive one of three anesthetic techniques including topical anesthetic gel, vibration using the Buzzy device, or cold pack application before and during needle insertion to reduce pain.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry- Alexandria University
Alexandria, Egypt, 21511
Actively Recruiting
Research Team
D
Dina A Sharaf, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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