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NCT Number: NCT06841601

Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception 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.

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Key information

Conditions

Pain Perception

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry- Alexandria University

Alexandria, 21511, Egypt

Location status: Recruiting

Location contact

Dina A Sharaf, PhD

CONTACT

[email protected]

4868308 ext. (203 )

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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

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.

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.

Primary outcomes

  1. Pain perception during needle insertion in different anesthetic techniques Using SEM scale

    Time frame: during the procedure (needle insertion)

    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.

Secondary outcomes

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

    Time frame: immediately after the procedure (needle insertion)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dina A Sharaf, PhD

CONTACT

[email protected]

01005319290 ext. 002

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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