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IRCT20260125068662N1 IRCT 2026-02-16 Khomein University of Medical Sciences The Effect of Aromatherapy on Pain and Hemodynamic Indices Comparing the effect of aromatherapy with rosemary and Mentha piperita essential oils on pain and hemodynamic indicators in patients after laparoscopic cholecystectomy 2026-02-09 anticipated 93 Complete https://irct.ir/trial/88800 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization will be employed to ensure the concealment of treatment allocation. For this purpose, the SealedEnvelope website will be utilized. The total sample size, the number of study arms (groups), and the desired block sizes (blocks of 6) will be entered into the aforementioned website. The output will be a randomized list detailing the number of subjects allocated to each study group (Control and Intervention). Subsequently, each eligible research subject will be assigned a sequential code based on their order of presentation/enrollment. By matching this code with the generated block randomization list, participating patients will be allocated to either the Intervention Group or the Control Group, Blinding description: The essential oils (active agents) and the placebo will be placed in identical, opaque, and uniformly labeled bottles. Each bottle will be coded, with only the patient’s unique identification code inscribed upon it. All acquired data will be recorded and entered into the statistical software using only the patient identification codes. The statistical analyst responsible for data processing and analysis will not have access to the group codes (i.e., will remain blinded). The group allocation will only be revealed after the analysis is complete. 3 cholecystectomy. Intervention 1: Intervention group 1: 3 drops of 100% Peppermint essential oil (for the mint group), prepared from the Giyah Kala company, are dropped onto a sterile cotton ball. This is attached to the patient’s collar at a distance of 20 cm, and the patient is instructed to perform deep inhalations for 5 to 10 minutes. Intervention 2: Intervention group2 : 3 drops of 25% Rosmary essential oil (for the mint group), prepared from the Giyah Kala company, are dropped onto a sterile cotton ball. This is attached to the patient’s collar at a distance of 20 cm, and the patient is instructed to perform deep inhalations for 5 to 10 minutes. Intervention 3: Control group: In the control group, the intervention is matched to the test group in terms of time and method of execution. The difference is that instead of the essential oil, 3 drops of scented distilled water will be used. No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information is available
public Fatemeh Salehi
Khomein University of Medical Sciences, Qods Blvd , Khomein
Khomein Iran (Islamic Republic of) 3819749058 +98 86 3280 0813 fatemeh.salehi1551@gmail.com Khomein University of Medical Sciences scientific Fatemeh Salehi
Khomein University of Medical Sciences, Blvd Qods , Khomein
Arak Iran (Islamic Republic of) 3819749058 +98 86 3280 0813 fatemeh.salehi1551@gmail.com Khomein University of Medical Sciences Iran (Islamic Republic of) Patients eligible for elective cholecystectomy surgery are adults (above 18 years of age) who have at least basic literacy (able to read and write) They must have no impairment of smell, speech, hearing, or vision no known allergy to peppermint or rosemary based on the initial patient interview and medical records Patients should have no history of pulmonary or respiratory diseases no substance abuse no use of anticoagulant medications no history of hypertension, and no psychiatric disorders. In addition, they should have no history of epilepsy or chronic headaches not be pregnant The postoperative pain intensity should be three or greater on the Visual Analogue Scale (Visual Analog Scale) Before starting the intervention, the effects of anesthesia must have completely worn off, and the patient should be fully conscious after the operation not connected to a ventilator, not receiving oxygen therapy, and able to breathe spontaneously 18 years no limit Both Use of analgesic or narcotic medications for pain relief beyond the routine postoperative orders. Presence of physical complications or instability in hemodynamic and physiological status, such as occurrence of cardiac arrhythmia, respiratory problems, abnormal bleeding blood pressure instability (including unusual increase or decrease during surgery or immediately after surgery in the recovery room), as well as any other abnormal condition reported by operating room staff or documented in the patient’s file. Z90.4 Acquired absence of other parts of digestive tract Prevention Prevention Prevention Intervention group 1: 3 drops of 100% Peppermint essential oil (for the mint group), prepared from the Giyah Kala company, are dropped onto a sterile cotton ball. This is attached to the patient’s collar at a distance of 20 cm, and the patient is instructed to perform deep inhalations for 5 to 10 minutes. Intervention group2 : 3 drops of 25% Rosmary essential oil (for the mint group), prepared from the Giyah Kala company, are dropped onto a sterile cotton ball. This is attached to the patient’s collar at a distance of 20 cm, and the patient is instructed to perform deep inhalations for 5 to 10 minutes. Control group: In the control group, the intervention is matched to the test group in terms of time and method of execution. The difference is that instead of the essential oil, 3 drops of scented distilled water will be used Postoperative pain intensity based on Visual Analog Scale. Timepoint: before the intervention (aromatherapy) and at 5, 15, 30, and 60 minutes after aromatherapy. Method of measurement: visual Analog Scale (VAS) will be used to determine the presence and severity of pain. Heart rate. Timepoint: Heart rate monitoring will be performed before the intervention (aromatherapy) and at 5, 15, 30, and 60 minutes after aromatherapy. Method of measurement: A portable monitor is used to measure heart rate. Systolic blood pressure. Timepoint: Blood pressure control will be performed before the intervention (aromatherapy) and at 5, 15, 30, and 60 minutes after aromatherapy. Method of measurement: Using a blood pressure monitor, portable monitor. Respiratory rate. Timepoint: Breathing rate will be monitored before the intervention (aromatherapy) and at 5, 15, 30, and 60 minutes after aromatherapy. Method of measurement: The number of breaths was also counted for one minute by the researcher using a stopwatch. Diastolic blood pressure. Timepoint: Blood pressure control will be performed before the intervention (aromatherapy) and at 5, 15, 30, and 60 minutes after aromatherapy. Method of measurement: Using a blood pressure monitor, portable monitor. Khomein University of Medical Sciences Approved 2026-01-12 Ethics committee of Khomein University of Medical Sciences Khomein University of Medical Sciences, Qods Blvd , Khomein Khomein Markazi Iran (Islamic Republic of)