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IRCT20230114057124N1 IRCT 2023-04-26 Tehran University of Medical Sciences Effect of Lavender aromatherapy on emergence agitation The effect of Lavender and Rose Aromatherapy on Emergence Agitation in Children Following Dental Treatment with General Anesthesia, A Clinical trial 2023-04-30 anticipated 57 Complete https://irct.ir/trial/68383 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. N/A Postoperative emergence delirium. Intervention 1: First intervention group: 30 minutes before starting the surgery, in the lavender group (A), 15 drops of lavender essential oil (Tabib Daro, Iran) is poured into 350 ml of city water and diffused by an aroma diffuser (Aroma Diffuser, Muji, Japan). The diffuser is placed in the recovery room where the child is transferred immediately after extubation. The diffuser remains on until the last child is discharged from the recovery ward. In the lavender and rose groups, the diffuser is filled as needed to establish the ratio of water and essential oil. Intervention 2: Intervention group: In this group, 10 drops of rose essential oil (Tabib Daro, Iran) is poured into 350 ml of city water and diffused by a diffuser. Details are similar to the lavender group. Intervention 3: Control group: In this group, the diffuser device containing 350 ml of city water is placed in the recovery without any additives. Details are similar to intervention groups. No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information
public Maryam Sadr Hosseini
North Karegar St,Tehran-Iran
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5801 ms-sadrhosseini@student.tums.ac.ir Tehran University of Medical Sciences scientific Saeede Mokhtari
Tehran university of medical sciences dental school, North Karegar St.,Tehran-Iran
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5801 smokhtari@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Children requiring dental treatment on deciduous teeth under general anesthesia Children classified as groups 1 and 2 of the ASA grading system 3 years 6 years Both Children requiring dental extraction Nasal obstruction F05.8 An etiologically nonspecific organic cerebral syndrome characterized by concurrent disturbances of consciousness and attention, perception, thinking, memory, psychomotor behaviour, emotion, and the sleep-wake schedule. The duration is variable and the deg Prevention Prevention Prevention First intervention group: 30 minutes before starting the surgery, in the lavender group (A), 15 drops of lavender essential oil (Tabib Daro, Iran) is poured into 350 ml of city water and diffused by an aroma diffuser (Aroma Diffuser, Muji, Japan). The diffuser is placed in the recovery room where the child is transferred immediately after extubation. The diffuser remains on until the last child is discharged from the recovery ward. In the lavender and rose groups, the diffuser is filled as needed to establish the ratio of water and essential oil. Intervention group: In this group, 10 drops of rose essential oil (Tabib Daro, Iran) is poured into 350 ml of city water and diffused by a diffuser. Details are similar to the lavender group. Control group: In this group, the diffuser device containing 350 ml of city water is placed in the recovery without any additives. Details are similar to intervention groups. The PAED score in the recovery room. Timepoint: 0, 10, 15 and 30 minutes after coming out of deep sedation. Method of measurement: PAED (pediatric anesthesia emergence delirium) scale. Tehran University of Medical Sciences Approved 2022-12-20 Research Ethics Committees of School of Dentistry- Tehran University of Medical Sciences Tehran university of medical sciences dental school, North Karegar St.,Tehran-Iran Tehran Tehran Iran (Islamic Republic of)