Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children

NCT ID: NCT06841601

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-23
• Study Completion Date: 2025-03-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

topical anesthetic gel

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Vibration

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Cold pack

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Dina Sharaf

Lecturer of Pediatric Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry- Alexandria University

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina A Sharaf, PhD

Role: CONTACT

dina.sharaf@alexu.edu.eg

01005319290 ext. 002

Facility Contacts

Dina A Sharaf, PhD

Role: primary

dent.admin@alexu.edu.eg

4868308 ext. (203 )

Other Identifiers

0568-12/22

Identifier Type: -

Identifier Source: org_study_id