Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children

Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception During Needle Insertion in Children

Local anesthesia is an anxiety-provoking procedure. Pain control is important for effective behavior guidance, specially among pediatric patients.

This study aims to evaluate the effectiveness of Buzzy® as a topical anesthetic in pain perception through two ways: once using vibration mode without the cold pack and the other using the cold pack without vibration and comparing it to topical anesthetic gel during different anesthetic techniques Methods: A randomized controlled clinical trial involving 72 healthy cooperative patients aged 5-9 years. They will be allocated to receive local anesthesia either using the vibration mode of Buzzy Bee (test group) or the cold pack of Buzzy Bee (test group) or conventional topical anesthetic gel (control group). Pain response will be assessed using Visual Analog Scale (VAS) and SEM scale.

Study Overview

• Status: Recruiting
• Conditions: Pain Perception
• Intervention / Treatment: Other: topical anesthetic gel; Other: Vibration; Other: Cold pack

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dina A Sharaf, PhD; Phone Number: 002 01005319290; Email: dina.sharaf@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt, 21511
    • Recruiting
    • Faculty of Dentistry- Alexandria University
    • Contact: Dina A Sharaf, PhD; Phone Number: (203 ) 4868308; Email: dent.admin@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients indicated for simple restorative procedures.
2. Children with physical status ASA I, II.
3. Children with no learning disabilities
4. Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
5. Patients whom parents will give consent to participate

Exclusion Criteria:

1. Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
2. Patients with acute oral or facial infection (swelling and/or cellulites)
3. Having active sites of pathosis in the area of injection that could affect anesthetic assessment.
4. Children with special health care needs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: topical anesthesia; Topical anesthetic gels are applied prior to injection at the injection site to minimize pain upon insertion of the needle during local anesthesia	Other: topical anesthetic gel; gels applied directly to the mucous membranes to provide localized relief of pain by numbing the area. They typically contain active ingredients such as lidocaine, benzocaine, or prilocaine, which work by blocking nerve signals to reduce sensation and discomfort
Experimental: vibration; Vibration using a vibrating devise (Buzzy) can help reduce the pain during local anesthesia injection. It is placed extra-orally before and during needle insertion	Other: Vibration; The vibration generated by the Buzzy device functions as a non-pharmacological agent that can reduce pain perception in children based on the principles of the Gate Control Theory of Pain.
Experimental: cold pack; Cold pack provided with the Buzzy device will be used without the vibration mode of the device. It is applied extra-orally before and during needle insertion.	Other: Cold pack; cold packs are also provided by the Buzzy device. they act as non-pharmacological agents that can reduce pain perception in children based on the Gate Control Theory of Pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception during needle insertion in different anesthetic techniques Using SEM scale	Objective method of pain assessment using SEM (sound, eye and movement scale). It is a behavioral assessment tool to evaluate pain and distress responses in children during dental procedures. It uses scores from 0 till 3 according to increasing levels of distress.	during the procedure (needle insertion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain will be assessed after local anesthesia injection by means of Visual analogue scale.	Subjective method of pain assessment where patients will be instructed how to point to the position on the line between faces to indicate how much pain they felt during local anesthesia administration. The total scores range from 0 to 10. Happy to sad faces are connected to the line, with a higher score indicating more severe pain	immediately after the procedure (needle insertion)

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Estimated): February 23, 2025
• Primary Completion (Estimated): March 25, 2025
• Study Completion (Estimated): March 25, 2025

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 0568-12/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No