The effect of Lavender and Rose Aromatherapy on Emergence Agitation in Children Following Dental Treatment with General Anesthesia, A Clinical trial

General goals: Assessment of the effect of lavender and rose aromatherapy on emergence agitation in children following dental treatment under general anesthesia

Randomized parallel-arm design, double-blind, a sample size of 57 patients

The study is carried out in the operating room of the pediatric department of the Faculty of Dentistry, Tehran University of Medical Sciences. After being extubated, the child enters the recovery room, where the diffuser was previously turned on. A fixed video camera is in front of the child's bed, broadcast live on a monitor outside the recovery room. In each group, 0, 10, 15, and 30 minutes after the child is out of deep sedation, emergence delirium, and pain severity are assessed by trained personnel; with PAED (Pediatric Anesthesia Emergence Delirium Scale) and mCHEOP scale (modified children's hospital of eastern Ontario pain scale) respectively. The assessment is done outside the recovery room. Therefore this person is blinded to the aroma used. During this time, the child's nausea or vomiting and need for painkillers are also recorded. After all data collection, statistical analysis is performed to look for meaningful differences between the three groups.

Inclusion criteria 1. Children between 3 to 6 years old 2. Children requiring dental treatment on deciduous teeth under general anesthesia 3. Children classified as groups 1 and 2 of the ASA (American Society of Anaesthesiologists) grading system 4. Parent or guardian's consent Exclusion criteria 1. Nasal obstruction 2. Children requiring dental extraction

Intervention groups 1. Lavender group 2. Rose group 3. control group

emergence delirium; pain severity; postoperative nausea and vomiting

Daily, about ten children are admitted for dental procedures under general anesthesia in the Faculty of Dentistry operating room between 7:00 am and 2:00 pm. The duration of surgeries vary, and the exact time children are brought to the recovery room is unknown. When the aroma diffuser is turned on in the recovery room, the plant's aroma remains until the end of the session, and it needs to be ventilated for the next aroma in the room. Therefore, it is possible to use one aroma each day, and all the children admitted will inhale the same aroma. According to the limitations of the intervention, random allocation is done in a cluster manner. Three identical bottles, one containing lavender, one containing rose, and one containing distilled water, are prepared. These bottles are named (A, B, C). Three closed envelopes are also prepared, each with one of A, B, or C written inside. The envelopes are numbered (1, 2, 3). On the first day of the trial, 1 hour before admission of the first patient, one of the numbers 1, 2, or 3 is selected using a random number generator, and the envelope is opened. Next, the contents of the corresponding bottle are poured into the diffuser. On the second day, using a random number generator, one of the numbers is selected, and the envelope is opened. On the third day, the remaining contents of the bottle are poured into the diffuser. On the fourth day, one of the three envelopes is chosen again. This process continues until the participants of all three groups reach 19 people.

Participant: The children's consciousness is altered after general anesthesia; therefore, they are considered blind. Researcher: Essential oils containers are identical and numbered. The researcher is unaware of the aroma assigned to each group. Outcome evaluator: To blind this person to the diffused aroma, the child's condition is filmed in the recovery room. The evaluator evaluates the child without being aware of the diffused aroma. Data Analyzer: Evaluations are recorded by bottle number. The analyzer is aware of the people in a group but unaware of the aroma assigned to each group.

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