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IRCT20101220005426N15 IRCT 2026-05-14 Kerman University of Medical Sciences Investigating the Effect of Lavender on the Level of Sedation in Hospitalized Children in the ICU Investigating the inhalation effect of lavender essential oil on sedation levels in children hospitalized in the intensive care unit (ICU) 2026-05-31 anticipated 70 Recruiting https://irct.ir/trial/89940 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting the patients, a block randomization method with block sizes of 4, 6, and 8 (using SPSS software) will be used to assign individuals to the two groups. This method will also ensure concealment of allocation. In this approach, each individual will be assigned a unique code, which will be attached to the medication packages, thereby also facilitating the blinding process. Patients will be placed into either the intervention group (35 patients) or the placebo group (35 patients), Blinding description: This is a double blinded study in which people will be divided into two control and intervention groups. Participants and data analyzers will not be not aware of the allocation of the study groups. 1 Agitation rate. Intervention 1: Intervention group: In the intervention group, in addition to the routine care provided in the intensive care unit (for controlling anxiety and agitation, which includes the use of sedatives such as benzodiazepines—e.g., midazolam at an initial dose of 0.1 mg/kg and a maintenance dose of 0.05 mg/kg/h, or lorazepam at an initial dose of 0.05 mg/kg—and haloperidol at an initial dose of 0.04 mg/kg and a maintenance dose of 0.05 mg/kg/day if agitation occurs, based on physician’s orders), lavender oil is also used to manage anxiety. The method involves soaking gauze with 5 drops of lavender extract (lavender essential oil from Royaye Salamat Company) at a 2% concentration, with a final linalool concentration of 0.5%. The gauze is placed 10 cm from the patient’s collar every 8 hours, and the patient inhales the vapor for 30 minutes. This intervention will be repeated three times per patient and will last a total of 24 hours. Intervention 2: Control group: In addition to routine intensive care unit (ICU) care (to manage anxiety and agitation, including the use of sedative benzodiazepines such as midazolam at an initial dose of 0.1 mg/kg and maintenance dose of 0.05 mg/kg/h, or lorazepam at an initial dose of 0.05 mg/kg, and haloperidol at an initial dose of 0.04 mg/kg and maintenance dose of 0.05 mg/kg/day if agitation occurs, as per physician’s order), patients will receive a placebo (distilled water) to control anxiety. The method is as follows: 5 drops of distilled water are applied to gauze, which is then attached to the patient’s collar at a distance of 10 cm, every eight hours. The patient inhales from it for 30 minutes. This intervention will be repeated three times per patient and will last a total of 24 hours. 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 According to IRCT policies, the IPD file is not publicly available; however, access can be requested by submitting a valid proposal to the ethics committee and the principal investigator
public Mehdi Ahmadinejad
Shahid Bahonar Hospital, Qarani St, Valiasr Crossroads, Shariaati St, Kerman
Kerman Iran (Islamic Republic of) 7613747181 +98 34 0223 5011 m.ahmadinejad@kmu.ac.ir Kerman University of Medical Sciences scientific Mehdi Ahmadinejad
Shahid Bahonar Hospital, Qarani St, Valiasr Crossroads, Shariaati St, Kerman
Kerman Iran (Islamic Republic of) 7613747181 +98 43 0223 5011 m.ahmadinejad@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Age 12 to 18 years GCS greater than or equal to 8 Admitted to intensive care units (ICU) Patient extubated at the time of study entry Hemodynamic stability No known history of hypersensitivity to lavender or other aromatic herbal compounds No history of chronic respiratory diseases No clinical signs or diagnosis of active pulmonary aspiration No primary or secondary immunodeficiency disorders Having a normal sense of smell Written informed consent from the patient’s parent or legal guardian 12 years 18 years Both Patient intubation Transfer of the patient to other units Patient death Sudden and significant changes in hemodynamic status Occurrence of any side effects F41.9 Anxiety disorder, unspecified Other Placebo Intervention group: In the intervention group, in addition to the routine care provided in the intensive care unit (for controlling anxiety and agitation, which includes the use of sedatives such as benzodiazepines—e.g., midazolam at an initial dose of 0.1 mg/kg and a maintenance dose of 0.05 mg/kg/h, or lorazepam at an initial dose of 0.05 mg/kg—and haloperidol at an initial dose of 0.04 mg/kg and a maintenance dose of 0.05 mg/kg/day if agitation occurs, based on physician’s orders), lavender oil is also used to manage anxiety. The method involves soaking gauze with 5 drops of lavender extract (lavender essential oil from Royaye Salamat Company) at a 2% concentration, with a final linalool concentration of 0.5%. The gauze is placed 10 cm from the patient’s collar every 8 hours, and the patient inhales the vapor for 30 minutes. This intervention will be repeated three times per patient and will last a total of 24 hours. Control group: In addition to routine intensive care unit (ICU) care (to manage anxiety and agitation, including the use of sedative benzodiazepines such as midazolam at an initial dose of 0.1 mg/kg and maintenance dose of 0.05 mg/kg/h, or lorazepam at an initial dose of 0.05 mg/kg, and haloperidol at an initial dose of 0.04 mg/kg and maintenance dose of 0.05 mg/kg/day if agitation occurs, as per physician’s order), patients will receive a placebo (distilled water) to control anxiety. The method is as follows: 5 drops of distilled water are applied to gauze, which is then attached to the patient’s collar at a distance of 10 cm, every eight hours. The patient inhales from it for 30 minutes. This intervention will be repeated three times per patient and will last a total of 24 hours. Aromatherapy. Timepoint: At the beginning and end of the intervention. Method of measurement: Charted information. RASS (Richmond Agitation-Sedation Scale) SCORE. Timepoint: At 0, 6, 12, 18, and 24 hours after the start of the intervention. Method of measurement: RASS table. BMI. Timepoint: At the beginning of the intervention. Method of measurement: File information. Age. Timepoint: At the beginning of the intervention. Method of measurement: File information. Gender. Timepoint: At the beginning of the intervention. Method of measurement: File information. Kerman University of Medical Sciences Approved 2026-02-01 Ethics committee, Kerman University of Medical Sciences Vice chancellor for research Kerman university of medical science, Jahad street Kerman Kerman Iran (Islamic Republic of)