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IRCT20231021059799N2 IRCT 2025-06-17 Bagheiat-allah University of Medical Sciences The effect of aromatherapy with lemon essence on nausea, vomiting, pain, and delirium after heart surgery Investigating the Effect of Inhalation Aromatherapy with Lemon Essence on Nausea, Vomiting, Pain, and Delirium in Patients Undergoing Coronary Artery Bypass Graft Surgery 2025-06-22 anticipated 104 Complete https://irct.ir/trial/83709 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization with blocks of four will be used. Random sequences will be generated using Microsoft Excel and its random function. Each allocation within the randomization sequence will receive a unique numerical code, and participants will be randomly assigned to either the intervention or control group. The treatment regimen corresponding to each random sequence will be placed in sealed envelopes labeled with the assigned code. These envelopes will then be placed in a box in random order. The assigned codes and corresponding treatment types will be recorded and maintained by the study epidemiologist, who will retain access to the randomization list, Blinding description: In this study, triple-blinding will be implemented, meaning that the participants, the study investigator, the outcome assessor, and the data analyst will all remain unaware of the assigned intervention (aromatherapy with lemon essential oil or placebo). Given the distinctive scent of lemon essential oil, specific measures will be taken to maintain participant blinding. Upon enrollment, participants will be informed that they are taking part in a study investigating the effects of a plant-based aroma, without any reference to the specific type of essential oil (lemon or bitter almond). This information will be clearly stated in the informed consent form. In the control group, a scentless bitter almond essential oil will be used, matched identically with the lemon oil in terms of bottle appearance, volume, color, and method of administration. Both types of essential oils will be prepared in sealed, coded envelopes by an individual not involved in the research team and assigned based on a randomization table. Participants will be aware that they are receiving one of two plant-based aromas, but they will not know whether they belong to the intervention or control group. Furthermore, no notable or perceivable difference in olfactory experience is expected, as the placebo will be presented as a "herbal extract" without drawing attention to the study design, thereby preserving participant blinding. The investigator and outcome assessor will also be blinded to the type of intervention through the use of anonymous codes and a randomization schedule generated by an independent third party. Similarly, the data analyst will analyze encrypted files without access to group allocation details. 3 Condition 1: Postoperative Delirium. Condition 2: Postoperative Nausea and Vomiting. Condition 3: Postoperative Pain. Intervention 1: "Intervention group:" Patients will undergo inhalation aromatherapy with lemon essence. The lemon essence, with 100% purity, is produced by Barij Essence Company, and its quality will be verified by the Quality Control Unit of Baqiyatallah University of Medical Sciences using gas chromatography-mass spectrometry. The essence contains 2–6% volatile compounds, including limonene and citral. The intervention will begin the night before surgery. Five drops of lemon essence will be placed on a cotton pad and positioned approximately 10 cm from the patient’s nose. This procedure will be repeated every four hours until the induction of anesthesia by a trained nurse blinded to group allocation. After surgery, during nasal oxygen administration, five drops of the essence will be added to the flowmeter at a rate of 4 liters per minute, applied uniformly across all patients in the intervention group. Once spontaneous breathing resumes, the intervention will continue using the previous method (five drops on a cotton pad placed 10 cm from the nose) every four hours until 24 hours after surgery. No intervention will be conducted during anesthesia induction or while the patient is intubated. Intervention 2: "Control group:" Patients will undergo inhalation aromatherapy with odorless bitter almond oil as a placebo. This essence, with 100% purity, is produced by Barij Essence Company and is identical to lemon essence in terms of packaging, color, concentration, volume, and method of administration. The intervention procedure in this group is the same as in the intervention group, with the only difference being the use of bitter almond essence instead of lemon essence.The intervention will begin the night before surgery. Five drops of bitter almond essence will be placed on a cotton pad and positioned approximately 10 cm from the patient’s nose. This procedure will be repeated every four hours until the induction of anesthesia by a trained nurse who is blinded to group allocation.After surgery, during nasal oxygen administration, five drops of bitter almond essence will be applied via the flowmeter at a rate of 4 liters per minute. Once spontaneous breathing resumes, the intervention will continue using the same method (five drops on a cotton pad placed 10 cm from the nose) and will be repeated every four hours for up to 24 hours postoperatively. No intervention will be conducted during anesthesia induction or while the patient is intubated. 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 A final decision regarding the sharing of de-identified individual participant data (IPD) has not yet been made, as it requires further evaluation of ethical requirements, patient privacy concerns, and the policies of Baqiyatallah University of Medical Sciences. Additionally, coordination with the ethics committee and other regulatory bodies to ensure compliance with data-sharing regulations is ongoing. A final decision will be made after the completion of the study and review of these considerations.
public Siavash Sangi
Baqiyatallah Al'Azam Hospital, After Sheikh Bahayi St., Molla Sadra Blvd., Vanak Square, Tehran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8804 0060 siavashsangi@gmail.com Bagheiat-allah University of Medical Sciences scientific Seyed Mohammad Reza Amouzegar Zavareh
Baqiyatallah Al'Azam Hospital, After Sheikh Bahayi St., Molla Sadra Blvd., Vanak Square, Tehran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8804 0060 Amouzegar12@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Age between 40 and 80 years Scheduled for coronary artery bypass graft surgery. ASA physical status class II and III. Patient is alert and oriented to time, place, and person, and able to speak No participation in other studies involving similar interventions. No history of postoperative delirium No diagnosis of known psychiatric disorders (e.g., severe depression, anxiety, psychosis, etc.) No history of alcohol use or antipsychotic drug consumption 40 years 80 years Both History of allergy related to herbal extracts. Presence of olfactory dysfunction or structural nasal damage. History of reoperation following cardiac surgery. Anticipated prolonged surgery duration beyond standard limits, as assessed by the cardiac surgeon. History of receiving higher-than-usual doses of opioid medications in the cardiac intensive care unit. High risk of severe postoperative bleeding as predicted by the clinical care team. F05 T88.5 T88.5 Delirium due to known physiological condition Other complications of anesthesia Other complications of anesthesia Prevention Placebo "Intervention group:" Patients will undergo inhalation aromatherapy with lemon essence. The lemon essence, with 100% purity, is produced by Barij Essence Company, and its quality will be verified by the Quality Control Unit of Baqiyatallah University of Medical Sciences using gas chromatography-mass spectrometry. The essence contains 2–6% volatile compounds, including limonene and citral. The intervention will begin the night before surgery. Five drops of lemon essence will be placed on a cotton pad and positioned approximately 10 cm from the patient’s nose. This procedure will be repeated every four hours until the induction of anesthesia by a trained nurse blinded to group allocation. After surgery, during nasal oxygen administration, five drops of the essence will be added to the flowmeter at a rate of 4 liters per minute, applied uniformly across all patients in the intervention group. Once spontaneous breathing resumes, the intervention will continue using the previous method (five drops on a cotton pad placed 10 cm from the nose) every four hours until 24 hours after surgery. No intervention will be conducted during anesthesia induction or while the patient is intubated. "Control group:" Patients will undergo inhalation aromatherapy with odorless bitter almond oil as a placebo. This essence, with 100% purity, is produced by Barij Essence Company and is identical to lemon essence in terms of packaging, color, concentration, volume, and method of administration. The intervention procedure in this group is the same as in the intervention group, with the only difference being the use of bitter almond essence instead of lemon essence.The intervention will begin the night before surgery. Five drops of bitter almond essence will be placed on a cotton pad and positioned approximately 10 cm from the patient’s nose. This procedure will be repeated every four hours until the induction of anesthesia by a trained nurse who is blinded to group allocation.After surgery, during nasal oxygen administration, five drops of bitter almond essence will be applied via the flowmeter at a rate of 4 liters per minute. Once spontaneous breathing resumes, the intervention will continue using the same method (five drops on a cotton pad placed 10 cm from the nose) and will be repeated every four hours for up to 24 hours postoperatively. No intervention will be conducted during anesthesia induction or while the patient is intubated. Incidence of delirium within 72 hours after coronary artery bypass graft surgery. Timepoint: Delirium will be assessed the night before surgery (as baseline), immediately after the patient’s transfer to the cardiac intensive care unit, and then daily up to 72 hours following coronary artery bypass graft surgery. Method of measurement: Delirium will be evaluated using the Intensive Care Delirium Screening Checklist by a nurse blinded to the intervention type. This tool consists of 8 items (altered level of consciousness, inattention, disorientation, hallucination-delusion-psychosis, psychomotor agitation or retardation, inappropriate speech or mood, sleep/wake cycle disturbance, and symptom fluctuation) used to diagnose delirium in patients admitted to the intensive care unit. Severity of pain within 72 hours after coronary artery bypass graft surgery. Timepoint: Pain intensity will be measured the night before surgery (as baseline), immediately after the patient’s transfer to the cardiac intensive care unit, and then at 6, 12, 24, 48, and 72 hours following coronary artery bypass graft surgery. Method of measurement: Pain intensity will be measured using the Numeric Pain Rating Scale. The patient selects a number between zero (no pain) and 10 (worst possible pain) and circles it. Additionally, the location of pain and the amount of opioid consumption will be recorded. Severity of nausea and vomiting within 72 hours after coronary artery bypass graft surgery. Timepoint: Nausea and vomiting intensity will be measured the night before surgery (as baseline), immediately after the patient’s transfer to the cardiac intensive care unit, and then at 6, 12, 24, 48, and 72 hours following coronary artery bypass graft surgery. Method of measurement: The intensity of nausea and vomiting will be measured using the Numeric Nausea and Vomiting Scale. The patient selects a number between zero (no nausea and vomiting) and 10 (worst possible nausea and vomiting) and circles it. Bagheiat-allah University of Medical Sciences Approved 2025-04-28 Baqiyatallah Al'Azam Educational and Medical Center (Research Ethics Committee) Baqiyatallah Al'Azam Hospital, After Sheikh Bahayi St., Molla Sadra Blvd., Vanak Square, Tehran Tehran Tehran Iran (Islamic Republic of)