Pain PerceptionNCT06841601
Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children
A study testing topical anesthetic gel, Vibration and Cold pack in people with Pain Perception, run by Alexandria University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Pain Perception
- What is being tested?
- topical anesthetic gel, Vibration and Cold pack
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Feb 2025to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry- Alexandria University
Alexandria, 21511
Dina A Sharaf, PhD, 4868308 ext. (203 ), dent.admin@alexu.edu.eg
About this study
Official title: Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception During Needle Insertion 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.
- Conditions
- Pain Perception
- Being tested
- topical anesthetic gel, Vibration, Cold pack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical anesthetic gelOther
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
VibrationOther
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 packOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Other: Cold pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: immediately after the procedure (needle insertion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start23 Feb 2025 (estimated)
- Primary completion25 Mar 2025 (estimated)
- Study completion25 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain PerceptionStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Sharaf, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841601
- Sponsor's protocol ID
- 0568-12/22
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception During Needle Insertion in Children
- ClinicalTrials.gov ID
- NCT06841601
- Acronym / sponsor ID
- 0568-12/22
- Conditions
- Pain Perception
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 23 Feb 2025 (estimated)
- Primary completion
- 25 Mar 2025 (estimated)
- Study completion
- 25 Mar 2025 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| topical anesthesia | Active comparator | Other: topical anesthetic gelTopical anesthetic gels are applied prior to injection at the injection site to minimize pain upon insertion of the needle during local anesthesia |
| vibration | Experimental | Other: VibrationVibration using a vibrating devise (Buzzy) can help reduce the pain during local anesthesia injection. It is placed extra-orally before and during needle insertion |
| cold pack | Experimental | Other: Cold packCold 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. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical anesthetic gelgels 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 | Other | topical anesthesia |
| VibrationThe 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. | Other | vibration |
| Cold packcold 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. | Other | cold pack |
Primary outcome
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.
1 secondary outcome
Pain will be assessed after local anesthesia injection by means of Visual analogue scale.
Time frame: immediately after the procedure (needle insertion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing topical anesthetic gel, Vibration and Cold pack in people with Pain Perception, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina A Sharaf, PhD (01005319290 ext. 002, dina.sharaf@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception during needle insertion in different anesthetic techniques Using SEM scale (time frame: during the procedure (needle insertion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.