Anxiety
Conditions
Brief 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. The patient is expected to answer the questions asked by the physician during the procedure.
Interventions
OTHERVemcaine
topical anesthetic spray
topical anesthetic effect of chamomile oil
OTHERVISION
topical anesthetic gel
OTHERICE
topical anesthetic effect of ice
Sponsors
Uşak University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * 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.
Exclusion criteria
* 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 * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS(Visual Analogue Scale) | 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 | 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) | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed