Investigation of The Effect of Lavender Oil Inhalation on Anxiety, Heart Rate And Blood Pressure of Children's Dental Treatment

Comparison of the effect of lavender oil inhalation with the control group on blood pressure, anxiety, and heart rate after anesthetic injection.

Randomized controlled clinical trial with a control group, single‑blind, parallel group, phase 3 conducted on 46 patients, Stratified block randomization with SPSS

Patients presenting to the Urmia Faculty of Dentistry who meet the study inclusion criteria will be stratified by gender and randomly allocated to intervention and control groups. In the intervention group, lavender oil will be inhaled before anesthetic injection, and distilled water in the control group. The principal investigator will be blinded to group allocation. Anxiety level, heart rate, and blood pressure will be measured before and after the intervention.

Inclusion criteria: healthy children with healthy systemic condition; patients aged 7 to 9 years; children requiring restorative treatment of a unilateral mandibular permanent first molar. Exclusion criteria: patients with previous dental treatment; dental pain

The intervention group receives inhalational lavender oil aroma (Essential oil will be obtained by hydrodistillation of dried plant parts and subsequently purifies with anhydrous sodium thiosulfate; Prepared at the Faculty of Pharmacology, Urmia University of Medical Sciences) 60 minutes before the start of dental procedures (anesthetic injection); 0.5 mL of the oil is dripped onto a 7.5 × 7.5 cm gauze and placed 20 cm from the child’s nose for 15 minutes. Control group: The same protocol will be followed, but with distilled water dripped onto the sterile gauze.

Anxiety; blood pressure; heart rate

In order to control for the confounding effect of gender on anxiety levels, stratified randomization will be used. For this purpose, participants will first be divided into two strata (girls and boys) based on gender. To allocate participants to the intervention and control groups, a random sequence will be generated using SPSS software, taking into account random blocks of a size of 4. The unit of randomization will be the individual participant. To ensure allocation concealment, the generated sequence will not be available to the main investigator, and sealed envelopes will be used so that the allocation of each individual to the groups will be performed by a person who does not play a role in the screening and enrollment process of the participants. Finally, 12 girls and 11 boys will be entered into the study in each group.

The researcher and the treating dentist will not be aware of the patient’s exposure to the aroma. The implementation of the intervention will be performed by another student who will have no role in data collection or data analysis. Following completion of the intervention, the room will be ventilated in order to maintain the blinding conditions, and subsequently the dental treatment will be initiated. In the control group, all procedures will be performed similarly, with the difference that sterile distilled water will be used on the gauze instead of lavender essence.