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IRCT20190119042406N1 IRCT 2019-02-11 Shiraz University of Medical Sciences Evaluation of the effect of aromatherapy on dental anxiety Evaluation of the effect of aromatherapy with lavender essential oil on dental anxiety by measuring pulse rate and salivary cortisol during dental treatment in pediatric patients 2019-02-04 anticipated 24 Complete https://irct.ir/trial/36943 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: Block permutation design was used to randomized patients to case and control groups, Blinding description: pediatric patients and the person who evaluates the consequences and the analyzer wont be aware of the goal of the aromatherapy. N/A Dental anxiety in pediatric patients. Intervention 1: Intervention group: Each patient receive restorative treatment under aromatherapy with lavender essential oil in the intervention session. 2 drops of pure lavender essential oil from Tisserand company is poured in 100 ml water in Zyklusmed humidifier and diffused in the air 30 minutes before patient's arrival. Intervention 2: Control group: Each patient receive restorative treatment without aromatherapy with lavender essential oil in the control session. Only water is poured in Zyklusmed humidifier and water steam diffuse in the air 30 minutes before patient's arrival. Yes - There is a plan to make this available What will be shared: After making the participants unknown, all data are accessible . When: Data will be accessible 6 months after publishing the results. To whom: University researchers Conditions: Data will be accessible to the studies in which these data are needed such as mete analysis. Where to obtain: Ghaderi_fa@sums.ac.ir solhjoo_neda@yahoo.com How to obtain: Applicants for data should present the researchers the university authorization. Comments:
public Neda Solhjou
Qom Abad Ave, Ghasredasht Blvd, Shiraz dental school
Shiraz Iran (Islamic Republic of) 713451836 +98 71 3626 3194 Solhjoo_Neda@yahoo.com Shiraz University of Medical Sciences scientific Faezeh Ghaderi
Shiraz dental school, Ghasrdasht St
Shiraz Iran (Islamic Republic of) 713451836 +98 71 3632 8096 ghaderi_fa@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Healthy children with 7-9 years of age Patients who exhibit Frank’s behavior rating grade III or IV Children who have decayed lower second primary molars bilaterally which need class I restorative treatment 7 years 9 years Both Patients who have any previous dental visit Children with common cold Children with history of allergy Children who currently use any medication Patients with any history of dental pain F06.4 Anxiety disorder due to known physiological condition Treatment - Other Placebo Intervention group: Each patient receive restorative treatment under aromatherapy with lavender essential oil in the intervention session. 2 drops of pure lavender essential oil from Tisserand company is poured in 100 ml water in Zyklusmed humidifier and diffused in the air 30 minutes before patient's arrival. Control group: Each patient receive restorative treatment without aromatherapy with lavender essential oil in the control session. Only water is poured in Zyklusmed humidifier and water steam diffuse in the air 30 minutes before patient's arrival. Salivary cortisol level. Timepoint: Saliva samples are collected before and after dental treatment. Method of measurement: The level of cortisol in saliva samples are detected using commercial ELISA cortisol kit. Pulse rate. Timepoint: Before the treatment, during the treatment after drilling, at the end of the treatment. Method of measurement: Finger type pulse oximeter. Patient’s anxiety in a subjective way. Timepoint: After injection of local anesthesia. Method of measurement: visual analog scale. Shiraz University of Medical Sciences Approved 2018-11-27 Ethics committee of Shiraz University of Medical Sciences Zand Blvd, Shiraz university of medical sciences. Shiraz Fars Iran (Islamic Republic of)