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IRCT20220107053654N2 IRCT 2026-07-14 Oroumia University of Medical Sciences Effect of Lavender Oil on The Anxiety, Heart Rate And Blood Pressure of Children Investigation of The Effect of Lavender Oil Inhalation on Anxiety, Heart Rate And Blood Pressure of Children's Dental Treatment 2025-10-23 anticipated 46 Complete https://irct.ir/trial/90006 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 local anesthetic injection. Intervention 1: 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. Intervention 2: Control group: Distilled water was administered by inhalation 60 minutes before the start of the dental procedure (local anesthetic injection). A total of 0.5 mL of distilled water was applied to a 7.5 × 7.5 cm gauze pad, which was placed 20 cm from the child's nose for 15 minutes. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its publication schedule has not yet been determined.
public Maryam Khosrozadeh
Mohtasham Street, Molavi 2, Behdari District Urmia, West Azerbaijan Province
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3365 0729 khosrozadeh.mm@gmail.com Oroumia University of Medical Sciences scientific Maryam Khosrozadeh
Mohtasham Street, Molavi 2, Behdari District Urmia, West Azerbaijan Province
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3365 0729 khosrozadeh.mm@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) children with healthy systemic condition Age of patients between 7 and 9 years Children requiring restorative treatment of the mandibular permanent first molar on one side 7 years 9 years Both Patients with prior dental treatment Children with symptoms of dental pain T41.3X5 Adverse effect of local anesthetics Treatment - Drugs Treatment - Drugs 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: Distilled water was administered by inhalation 60 minutes before the start of the dental procedure (local anesthetic injection). A total of 0.5 mL of distilled water was applied to a 7.5 × 7.5 cm gauze pad, which was placed 20 cm from the child's nose for 15 minutes. Anxiety. Timepoint: During local anesthetic administration; 60 minutes after the intervention. Method of measurement: Facial rating scale. Heart rate. Timepoint: Once before receiving the inhaled aroma; and again 1 minute after completion of the local anesthetic injection. Method of measurement: Digital sphygmomanometer. Systolic blood pressure. Timepoint: Once before receiving the inhaled aroma; and again 1 minute after completion of the local anesthetic injection. Method of measurement: Digital sphygmomanometer. Diastolic blood pressure. Timepoint: Once before receiving the inhaled aroma; and again 1 minute after completion of the local anesthetic injection. Method of measurement: Digital sphygmomanometer. Oroumia University of Medical Sciences Approved 2025-10-22 Research Ethics Committees of Urmia University of Medical Sciences Urmia University of Medical Sciences, Emergency Alley, Resalat St., Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)