Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children

NCT06841601 | Recruiting

• 1 other identifier: 0568-12/22
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Perception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain will be assessed after local anesthesia injection by means of Visual analogue scale.

  immediately after the procedure (needle insertion)

Study Arms (3)

topical anesthesia

ACTIVE COMPARATOR

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

vibration

EXPERIMENTAL

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

cold pack

EXPERIMENTAL

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

Interventions

topical anesthetic gel OTHER

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

topical anesthesia

Vibration OTHER

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.

vibration

Cold pack OTHER

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.

cold pack

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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 cellulites)
• Having active sites of pathosis in the area of injection that could affect anesthetic assessment.
• Children with special health care needs.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry- Alexandria University

Alexandria, 21511, Egypt

RECRUITING

MeSH Terms

Interventions

Vibration

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Central Study Contacts

Dina A Sharaf, PhD

CONTACT

01005319290; dina.sharaf@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatric Dentistry

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 24, 2025
• Study Start: February 23, 2025
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

EG (1)