AnxietyNCT07849192
COMPARISON OF THE TOPICAL ANAESTHETIC EFFICACY OF VARIOUS AGENTS WITH ANAESTHETIC EFFECTS IN CHILDREN
A study testing Vemcaine, Essences and Essential Oils and VISION in people with Anxiety, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to compare the effectiveness of natural methods-such as basil oil, chamomile oil, and ice-with synthetic topical anesthetics, such as topical anesthetic sprays and topical anesthetic creams, and to assess their effects on pain and anxiety levels in children. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Vemcaine, Essences and Essential Oils and VISION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 19 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged 6-12 years
- Patients requiring buccal infiltration anesthesia in the upper jaw
- Upper jaw teeth requiring restoration that do not exhibit pain, pulpitis, or percussion symptoms and do not have an abscess
- Patients with no open lesions, trauma, etc., in the anesthetic area inside the mouth
- Patients who are willing to participate and have signed an informed consent form
- Patients with no known allergy to topical anesthetic agents or their derivatives
Show all 9Show fewer
- Patients without systemic disorders or serious mental/psychological disorders -Patients without any allergies (non-atopic)
- Patients who have not taken any medications within the past 24 hours that could affect their pain threshold (e.g., analgesics, anxiolytics, anti-inflammatory drugs)
- Patients scoring 3 or 4 (positive, definitely positive) on the Frankl Behavior Scale.
Who cannot join
- Patients younger than 6 years or older than 12 years
- Patients who do not require maxillary buccal infiltration anesthesia
- Patients with maxillary teeth presenting with pain, tenderness to percussion, symptoms of pulpitis, or the presence of an abscess
- Patients with any open lesion, aphthous ulcer, trauma, or similar condition in the intraoral area where anesthesia will be administered
- Patients who are unwilling to participate and do not sign the informed consent form
- Patients with a known allergy to topical anesthetic agents or their derivatives
Show all 10Show fewer
- Patients with systemic disorders or severe mental/psychological disorders
- Patients with any known allergy (atopic individuals)
- Patients who have used medications within the previous 24 hours that may affect the pain threshold (e.g., analgesics, anxiolytics, or anti-inflammatory drugs)
- Patients with a score of 1 or 2 on the Frankl Behavior Rating Scale (definitely negative or negative).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF THE TOPICAL ANAESTHETIC EFFICACY OF VARIOUS AGENTS WITH ANAESTHETIC EFFECTS AND EVALUATION OF THEIR EFFECTS ON PAIN AND ANXIETY IN CHILDREN
The purpose of the study is to compare the effectiveness of natural methods-such as basil oil, chamomile oil, and ice-with synthetic topical anesthetics, such as topical anesthetic sprays and topical anesthetic creams, and to assess their effects on pain and anxiety levels in children. The patient is expected to answer the questions asked by the physician during the procedure.
- Conditions
- Anxiety
- Being tested
- Vemcaine, Essences and Essential Oils, VISION, ICE
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VemcaineOther
topical anesthetic spray
Essences and Essential OilsOther
topical anesthetic effect of chamomile oil
VISIONOther
topical anesthetic gel
ICEOther
topical anesthetic effect of ice
Essences and Essential OilsOther
topical anesthetic effect of basil oil
| Study group | Role | What they receive |
|---|---|---|
| Topical Anesthetic Spray | Active comparator | Not described Receives: Other: Vemcaine |
| Topical Anesthetic Gel | Active comparator | Not described Receives: Other: VISION |
| Ice | Active comparator | Not described Receives: Other: ICE |
| Basil Oil | Active comparator | Not described Receives: Other: Essences and Essential Oils |
| Chamomile Oil | Active comparator | Not described Receives: Other: Essences and Essential Oils |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS(Visual Analogue Scale)
The VAS is widely used worldwide to measure pain intensity. It is rated on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain imaginable.
Measured: during topical and local anesthesia procedure
SEM (SOUND, EYE, MOTOR) SCALE
The SEM scale is used to objectively assess anxiety. It evaluates anxiety based on vocalizations, eye signs, and motor movements. Each measure is assigned a score ranging from 1 to 4, where 1 = comfortable and 4 = severe discomfort. The total score ranges from 3 to 12, where 3 = comfortable and 12 = severe discomfort. The total score is calculated as the sum of the three scores assigned for vocalizations, eye signs, and motor movements.
Measured: during topical and local anesthesia procedure
Finger-Type Pulse Oximeter (heart rate measurement device)
A finger-type pulse oximeter is a non-invasive method that allows us to assess changes in oxygen saturation in arterial blood through the skin. Using a pulse oximeter, changes in oxygen saturation levels and heart rate can be measured within a short period of time.
Measured: during topical and local anesthesia procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Apr 2025
- Primary completion2 Jun 2025
- Study completion19 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849192
- Sponsor's protocol ID
- 581-581-03
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual patient data may be shared only for the purpose of publishing the results, but I haven't decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE TOPICAL ANAESTHETIC EFFICACY OF VARIOUS AGENTS WITH ANAESTHETIC EFFECTS AND EVALUATION OF THEIR EFFECTS ON PAIN AND ANXIETY IN CHILDREN
- ClinicalTrials.gov ID
- NCT07849192
- Acronym / sponsor ID
- 581-581-03
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 19 Oct 2025 (actual)
- First posted
- 30 Sep 2026 (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.
The purpose of the study is to compare the effectiveness of natural methods-such as basil oil, chamomile oil, and ice-with synthetic topical anesthetics, such as topical anesthetic sprays and topical anesthetic creams, and to assess their effects on pain and anxiety levels in children. The patient is expected to answer the questions asked by the physician during the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Topical Anesthetic Spray | Active comparator | Other: Vemcaine |
| Topical Anesthetic Gel | Active comparator | Other: VISION |
| Ice | Active comparator | Other: ICE |
| Basil Oil | Active comparator | Other: Essences and Essential Oils |
| Chamomile Oil | Active comparator | Other: Essences and Essential Oils |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patients aged 6-12 years
- Patients requiring buccal infiltration anesthesia in the upper jaw
- Upper jaw teeth requiring restoration that do not exhibit pain, pulpitis, or percussion symptoms and do not have an abscess
- Patients with no open lesions, trauma, etc., in the anesthetic area inside the mouth
- Patients who are willing to participate and have signed an informed consent form
Key exclusion criteria (10 listed)
- Patients younger than 6 years or older than 12 years
- Patients who do not require maxillary buccal infiltration anesthesia
- Patients with maxillary teeth presenting with pain, tenderness to percussion, symptoms of pulpitis, or the presence of an abscess
- Patients with any open lesion, aphthous ulcer, trauma, or similar condition in the intraoral area where anesthesia will be administered
- Patients who are unwilling to participate and do not sign the informed consent form
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 |
|---|---|---|
| Vemcainetopical anesthetic spray | Other | Topical Anesthetic Spray |
| Essences and Essential Oilstopical anesthetic effect of chamomile oil | Other | Chamomile Oil |
| VISIONtopical anesthetic gel | Other | Topical Anesthetic Gel |
| ICEtopical anesthetic effect of ice | Other | Ice |
| Essences and Essential Oilstopical anesthetic effect of basil oil | Other | Basil Oil |
Primary outcome
VAS(Visual Analogue Scale)
Time frame: during topical and local anesthesia procedure
The VAS is widely used worldwide to measure pain intensity. It is rated on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain imaginable.
SEM (SOUND, EYE, MOTOR) SCALE
Time frame: during topical and local anesthesia procedure
The SEM scale is used to objectively assess anxiety. It evaluates anxiety based on vocalizations, eye signs, and motor movements. Each measure is assigned a score ranging from 1 to 4, where 1 = comfortable and 4 = severe discomfort. The total score ranges from 3 to 12, where 3 = comfortable and 12 = severe discomfort. The total score is calculated as the sum of the three scores assigned for vocalizations, eye signs, and motor movements.
Finger-Type Pulse Oximeter (heart rate measurement device)
Time frame: during topical and local anesthesia procedure
A finger-type pulse oximeter is a non-invasive method that allows us to assess changes in oxygen saturation in arterial blood through the skin. Using a pulse oximeter, changes in oxygen saturation levels and heart rate can be measured within a short period of time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided. Individual patient data may be shared only for the purpose of publishing the results, but I haven't decided yet.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vemcaine, Essences and Essential Oils and VISION in people with Anxiety, run by Uşak University at 1 site in Turkey (Türkiye).
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 9 inclusion and 10 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: finished, as of the sponsor's last update on 30 Sep 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS(Visual Analogue Scale) (time frame: during topical and local anesthesia procedure). The study lists 3 primary outcomes in all. 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 30 Sep 2026.