Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children
ConditionPain Perception
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-9
SponsorAlexandria University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
topical anesthetic gel
Other interventiongels 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 interventionThe 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 interventioncold 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.
Treatment groups
72 Participants
are divided into 3 treatment groupsGroup A: topical anesthesiaActive comparator 1 intervention
Group B: vibrationExperimental treatment 1 intervention
Group C: cold packExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
during the procedure (needle insertion)Secondary outcomes
1
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
Time frame
immediately after the procedure (needle insertion)Sponsors and contacts
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Source ClinicalTrials.gov