NCT06841601 Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children
| NCT ID | NCT06841601 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alexandria University |
| Condition | Pain Perception |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-02-23 |
| Primary Completion | 2025-03-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2025-02-23 with a primary completion date of 2025-03-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06841601 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 9 Years, studying Pain Perception. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06841601 currently recruiting?
Yes, NCT06841601 is actively recruiting participants. Contact the research team at dina.sharaf@alexu.edu.eg for enrollment information.
Where is the NCT06841601 trial being conducted?
This trial is being conducted at Alexandria, Egypt.
Who is sponsoring the NCT06841601 clinical trial?
NCT06841601 is sponsored by Alexandria University. The trial plans to enroll 72 participants.