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IRCT20231021059795N3 IRCT 2026-10-26 Shahid Beheshti University of Medical Sciences Effect of Inhalational Aromatherapy with Lemon Essential Oil in Patients Undergoing Open-Heart Surgery Investigating the Effect of Inhalational Aromatherapy with Lemon Essential Oil on Hemodynamic Stability, Inflammatory Markers, Sedation, Sleep Quality, and Delirium in Patients Undergoing Open-Heart Surgery 2026-11-06 anticipated 104 Recruiting https://irct.ir/trial/94248 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Following convenience sampling and eligibility assessment, patients will be individually randomized in a 1:1 ratio to the intervention or control group using block randomization with a block size of four. The random sequence will be generated using the RAND function in Microsoft Excel. Allocation will be concealed using identical, opaque, sealed envelopes bearing unique codes. Intervention preparation and coding will be performed by an independent research team member, Blinding description: Participants, healthcare staff responsible for their care, and data analysts will remain unaware of the group allocation. Participants will be informed that they will receive a pleasant, neutral scent as part of their care, without the specific type of essential oil being disclosed. Lime essential oil (the intervention) and bitter almond essential oil (the control) will be diluted to the same concentration, placed in coded bottles that are identical in appearance and packaging, and prepared by an independent anesthesiologist. Bitter almond essential oil is used as a control due to its mild scent. Outcome assessments will be conducted by blinded intensive care unit staff. Data will be entered into SPSS software using anonymized codes, and the identities of the groups will be revealed only after the statistical analysis is complete. 3 Condition 1: Hemodynamics. Condition 2: Inflammatory markers. Condition 3: Sedation. Condition 4: Sleep Quality. Condition 5: Delirium. Intervention 1: Intervention group:Inhalational aromatherapy with standardized lemon essential oil. Five drops of lemon essential oil are applied to sterile cotton and administered every two hours, beginning on the night before surgery and continuing until the patient is transferred to the operating room. The intervention is discontinued during general anesthesia and mechanical ventilation. After admission to the cardiac intensive care unit, five drops of lemon essential oil are placed in the oxygen flowmeter set at a flow rate of 4 liters per minute while the patient receives oxygen via nasal cannula. Following the return of spontaneous breathing and extubation, the intervention is resumed using the same method every two hours and continued until 24 hours after surgery. Intervention 2: Control group: Inhalational aromatherapy with bitter almond oil as a placebo. Five drops of bitter almond oil are applied to sterile cotton and administered every two hours according to the same schedule as the intervention group, beginning on the night before surgery and continuing until the patient is transferred to the operating room. The intervention is discontinued during general anesthesia and mechanical ventilation. After admission to the cardiac intensive care unit, five drops of bitter almond oil are placed in the oxygen flowmeter set at a flow rate of 4 liters per minute while the patient receives oxygen via nasal cannula. Following the return of spontaneous breathing and extubation, the intervention is resumed every two hours and continued until 24 hours after surgery. All other study procedures are identical in both groups. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main result or the like, can be shared. When: Access period 6 months after publication of results To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: No special conditions are considered. Where to obtain: Siavash Sangi siavashsangi@gmail.com How to obtain: After receiving the applicant's email, the documents will be sent in a short period of time. Comments:
public Siavash Sangi
Niayesh Intersection - Shahid Beheshti School of Nursing and Midwifery
Tehran Iran (Islamic Republic of) 1996835119 88655366 siavashsangi@gmail.com Shahid Beheshti University of Medical Sciences scientific Siavash Sangi
Tehran, Vali Asr Street, Ayatollah Hashemi Rafsanjani Highway Intersection, in front of Shahid Rajaee Heart Hospital, Faculty of Nursing and Midwifery
Tehran Iran (Islamic Republic of) 1996835119 88655366 siavashsangi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 40 and 80 years Scheduled for elective open-heart surgery, particularly coronary artery bypass grafting (CABG). American Society of Anesthesiologists (ASA) physical status class I–III Adequate consciousness, orientation to time, place, and person, and intact verbal communication at the time of consent Provision of written informed consent. 40 years 80 years Both 1. Known allergy to lemon essential oil or the herbal preparations used in the study. Olfactory impairment or nasal obstruction interfering with adequate inhalation Active severe psychiatric disorder that may interfere with outcome assessment Personal or family history of postoperative delirium Concurrent participation in a similar clinical trial. - . . . T88.59 - . . . Other complications of anesthesia Prevention Placebo Intervention group:Inhalational aromatherapy with standardized lemon essential oil. Five drops of lemon essential oil are applied to sterile cotton and administered every two hours, beginning on the night before surgery and continuing until the patient is transferred to the operating room. The intervention is discontinued during general anesthesia and mechanical ventilation. After admission to the cardiac intensive care unit, five drops of lemon essential oil are placed in the oxygen flowmeter set at a flow rate of 4 liters per minute while the patient receives oxygen via nasal cannula. Following the return of spontaneous breathing and extubation, the intervention is resumed using the same method every two hours and continued until 24 hours after surgery. Control group: Inhalational aromatherapy with bitter almond oil as a placebo. Five drops of bitter almond oil are applied to sterile cotton and administered every two hours according to the same schedule as the intervention group, beginning on the night before surgery and continuing until the patient is transferred to the operating room. The intervention is discontinued during general anesthesia and mechanical ventilation. After admission to the cardiac intensive care unit, five drops of bitter almond oil are placed in the oxygen flowmeter set at a flow rate of 4 liters per minute while the patient receives oxygen via nasal cannula. Following the return of spontaneous breathing and extubation, the intervention is resumed every two hours and continued until 24 hours after surgery. All other study procedures are identical in both groups. Hemodynamic changes, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate, after surgery. Timepoint: The night before surgery, before anesthesia induction, upon intensive care unit admission, and 6, 12, 24, 48, and 72 hours after surgery. Method of measurement: Systolic, diastolic, and mean arterial pressure measured by invasive arterial monitoring, and heart rate recorded using electrocardiography. Changes in serum C-reactive protein levels as an inflammatory marker in patients undergoing open-heart surgery. Timepoint: The night before surgery, before anesthesia induction, and at discharge from the cardiac intensive care unit. Method of measurement: Measurement of serum C-reactive protein levels in venous blood samples using a validated laboratory method. Changes in serum cortisol levels as a marker of the physiological response to surgical stress. Timepoint: The night before surgery, before anesthesia induction, and at discharge from the cardiac intensive care unit. Method of measurement: Measurement of serum cortisol levels in venous blood samples using a validated laboratory method. Changes in the neutrophil-to-lymphocyte ratio as an inflammatory marker in patients undergoing open-heart surgery. Timepoint: The night before surgery, before anesthesia induction, and at discharge from the cardiac intensive care unit. Method of measurement: Calculation of the neutrophil-to-lymphocyte ratio using the differential white blood cell count from venous blood samples. Changes in the level of sedation and agitation in patients after open-heart surgery. Timepoint: Upon admission to the cardiac intensive care unit and 6, 12, 24, 48, and 72 hours after surgery. Method of measurement: Assessment of sedation and agitation using the Richmond Agitation-Sedation Scale at the specified time points. Changes in sleep quality in patients after open-heart surgery. Timepoint: On the mornings of postoperative days 1, 2, and 3, after the patient has fully regained consciousness. Method of measurement: Assessment of sleep quality using the Richards-Campbell Sleep Questionnaire, based on the patient's responses to the questionnaire items at the specified time points. Incidence of postoperative delirium in patients admitted to the cardiac intensive care unit. Timepoint: During the cardiac intensive care unit stay, up to 72 hours after surgery. Method of measurement: Delirium is screened using the Intensive Care Delirium Screening Checklist by trained nurses blinded to group allocation. Shahid Beheshti University of Medical Sciences Approved 2026-07-17 Faculties of Pharmacy, Nursing, and Midwifery – Shahid Beheshti University of Medical Sciences Valiasr Street, intersection with Ayatollah Hashemi Rafsanjani Highway, opposite the Cardiovascular Hospital. Tehran Tehran Iran (Islamic Republic of)