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IRCT20240929063203N7 IRCT 2026-05-28 Bandare-abbas University of Medical Sciences Effectiveness of Aromatherapy with Lavender Essential Oil Compared to Rosa Damascena on Reducing Delirium and Improving Clinical Outcomes in Multiple Trauma Patients in the Intensive Care Unit Effectiveness of Aromatherapy with Lavender Essential Oil Compared to Rosa Damascena on Reducing Delirium and Improving Clinical Outcomes in Multiple Trauma Patients in the Intensive Care Unit 2026-05-31 anticipated 123 Recruiting https://irct.ir/trial/90232 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this clinical trial, individual randomization is performed using block randomization with block sizes of 3, 6, and 9. Multiple trauma patients admitted to the intensive care unit of Payambar-e-Azam Educational and Medical Center who meet the inclusion criteria are randomly and equally assigned to three groups: two intervention groups (receiving lavender essential oil and rose essential oil) and a control group (receiving distilled water), Blinding description: This study is a double-blind clinical trial. In this investigation, patients (participants) and the nurses responsible for administering the intervention, outcome assessment, and clinical care will be completely blinded to the group allocation and the type of scent received. To maintain blinding, the intervention is carried out under the supervision of a blinded nurse, and patients in the control group will receive distilled water (as a placebo) with an identical appearance and inhalation method to the intervention groups (lavender and rose essential oils) so that no difference is perceived in the procedure. This design minimizes the risk of performance bias and detection bias. 3 Condition 1: Delirium. Condition 2: Multiple trauma. Intervention 1: Intervention group: After randomization, patients in the first intervention group receive aromatherapy with pure lavender essential oil in addition to standard ICU care. The essential oil is certified for purity and quality and has a minimum purity of 98%. A sterile 4×44×4 gauze pad is impregnated with 5 drops of lavender essential oil and placed approximately 10 cm from the patient’s nose (attached to the patient’s collar). Patients are instructed to inhale the aroma for 30 minutes. The intervention is performed once daily between 8–9 AM for five consecutive days or until ICU discharge, whichever occurs first. Intervention 2: Intervention group: Patients in the second intervention group receive aromatherapy with pure Rosa damascena (rose) essential oil in addition to standard care. The administration protocol is identical to the lavender group. A sterile 4×44×4 gauze pad impregnated with 5 drops of rose essential oil is placed approximately 10 cm from the patient’s nose, and the patient inhales the aroma for 30 minutes. The intervention is administered once daily between 8–9 AM for five consecutive days or until ICU discharge. Intervention 3: Control group: Patients in the control group receive standard ICU care only and no aromatherapy intervention. To maintain blinding, a similar container with distilled water is placed near the patient’s pillow to mimic the intervention conditions. 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 Still undecided - no release schedule yet.
public Milad Mohammadi
Aila 2 Building, No. 3/9 Nour Alley, Emam Hossein Blvd, Nour Town
بندر عباس Iran (Islamic Republic of) 7919884206 +98 76 9999 4691 miladmohammadi981@gmail.com Bandare-abbas University of Medical Sciences scientific Majid Vatankhah
Next to Recovery, 5-story building, first floor, Shahid Mohammadi Hospital, Islamic Republic Blvd., Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3334 5009 hormozgan91@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Patients aged between 18 and 65 years Injury Severity Score (ISS) less than 15 Glasgow Coma Scale (GCS) score greater than 8 No known allergy or sensitivity to essential oils Providing informed consent to participate in the study 18 years 65 years Both Presence of baseline delirium at admission History of psychiatric disorders Presence of olfactory disorders F05 M12.59 Delirium due to known physiological condition Traumatic arthropathy, multiple sites Treatment - Other Treatment - Other Treatment - Other Intervention group: After randomization, patients in the first intervention group receive aromatherapy with pure lavender essential oil in addition to standard ICU care. The essential oil is certified for purity and quality and has a minimum purity of 98%. A sterile 4×44×4 gauze pad is impregnated with 5 drops of lavender essential oil and placed approximately 10 cm from the patient’s nose (attached to the patient’s collar). Patients are instructed to inhale the aroma for 30 minutes. The intervention is performed once daily between 8–9 AM for five consecutive days or until ICU discharge, whichever occurs first. Intervention group: Patients in the second intervention group receive aromatherapy with pure Rosa damascena (rose) essential oil in addition to standard care. The administration protocol is identical to the lavender group. A sterile 4×44×4 gauze pad impregnated with 5 drops of rose essential oil is placed approximately 10 cm from the patient’s nose, and the patient inhales the aroma for 30 minutes. The intervention is administered once daily between 8–9 AM for five consecutive days or until ICU discharge. Control group: Patients in the control group receive standard ICU care only and no aromatherapy intervention. To maintain blinding, a similar container with distilled water is placed near the patient’s pillow to mimic the intervention conditions. Incidence of delirium in admitted patients. Timepoint: Daily from the beginning of the study for 5 days (or until discharge from the intensive care unit if discharged earlier). Method of measurement: Clinical assessment/0-7 points. Mean score of delirium severity. Timepoint: Daily from the start of the intervention for 5 days (or until discharge from the intensive care unit). Method of measurement: Clinical assessment/0-8 points. Patient’s level of consciousness, sedation, and agitation. Timepoint: Daily from the beginning of the intervention for 5 days (or until discharge from the intensive care unit). Method of measurement: Richmond Agitation-Sedation Scale. Length of stay in the intensive care unit. Timepoint: From the time of admission until discharge from the intensive care unit. Method of measurement: Recording the number of hospitalization days based on the clinical records. Length of hospital stay. Timepoint: From admission to final discharge from the hospital. Method of measurement: Recording the total number of hospitalization days by reviewing the medical records. Duration of mechanical ventilation. Timepoint: From intubation to successful extubation (weaning from the ventilator). Method of measurement: Calculating the days and hours on mechanical ventilation recorded in nursing reports. Consumption of sedative and antipsychotic medications. Timepoint: Daily during the intervention period (up to 5 days) or until discharge from the intensive care unit. Method of measurement: Recording the total dose and type of received medications by reviewing physician orders and pharmacological records. Pain intensity. Timepoint: Daily assessment for 5 days or until discharge from the intensive care unit. Method of measurement: Using standard pain assessment tools (e.g., behavioral pain scales for unconscious patients or Visual Analogue Scale). Mortality rate. Timepoint: During the hospitalization period. Method of measurement: Recording the patient’s survival or death status in the medical records. Bandare-abbas University of Medical Sciences Approved 2026-01-27 Research Ethics Committees of Hormozgan University of Medical Sciences Shahid Chamran Boulevard, University of Medical Sciences and Health Services, Bandar Abbas. Bandar Abbas Hormozgan Iran (Islamic Republic of)