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IRCT20200811048374N1 IRCT 2021-03-01 Shahed University Citrus Aurantium aroma on pain and physiological criteria The Effect of Citrus Aurantium aroma on pain and physiological criteria of patients undergoing hand reconstructive surgery hospitalized in intensive care unit 2020-08-22 anticipated 76 Complete https://irct.ir/trial/53169 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Prevention, Randomization description: According to the required number of samples, a total of 76 patients were estimated، 38 patients in the experimental group and 38 patients in the control group. Randomization was performed by simple method with Excel software with 76 numbers in two groups and in each group 38 numbers were placed randomly, Blinding description: there are glass containers in the similar package with the code ، containing equal amounts of placebo and Citrus Aurantium . The researcher without knowing the type of solution of each container, randomly selected one of the containers and used its solution for the research sample with inclusion criteria and then recorded the data. The samples were not aware of the type of solution used. N/A Pain and physiologic criteria. Intervention 1: Intervention group: After surgery in the recovery room, while the patient is is conscious , before performing the intervention, 1- pain and physiological parameters are measured. 2-The researcher, Citrus Aurantium solution pours on the pad 2 * 2(0.4 ml ),the pad is taken a distance of 5 cm from the nose up to ten breaths and then the pad was attached to the patient's collar, after half an hour, pain and physiological measurements are checked and recorded. 3-After transferring the patient from the recovery room to the intensive care unit while the pad is attached to the patient's collar, one hour after the second recording, the pain and physiological criteria are checked and recorded . Intervention 2: Control group: After surgery in the recovery room, while the patient is is conscious , before performing the intervention, 1- pain and physiological parameters are measured. 2-The researcher,placebo solution pours on the pad 2 * 2(0.4 ml ), the pad is taken a distance of 5 cm from the nose up to ten breaths and then the pad was attached to the patient's collar, after half an hour, pain and physiological measurements are checked and recorded. 3-After transferring the patient from the recovery room to the intensive care unit while the pad is attached to the patient's collar, one hour after the second recording, the pain and physiological criteria are checked and recorded . 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 After analyzing the data, a decision is made about publishing
public Nasrin Alaee
Shahed University in front of Imam Khomeini Shrine Persian Gulf Highway
Tehran Iran (Islamic Republic of) 3319116851 +98 21 5121 2130 n_alaie@yahoo.com Shahed University scientific Nasrin Alaee
Shahed university In front of the holy shrine of Imam Khomeini Persian Gulf Highway
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 2130 n_alaie@yahoo.com Shahed University Iran (Islamic Republic of) Patient undergoing reconstructive hand surgery who are is transferred to the intensive care unit after surgery The patient is alert and awake and the ability to understand and express the pain and the patient is able to cooperate Age range over 18 years based on the year of birth Healthy sense of smell according to the patient 18 years 80 years Both Drug addiction (according to the patient statement and the file) Uncontrolled diabetes and neuropathy Mental illness and cognitive disorders based on the records in patient's file History of respiratory allergies, asthma, allergic rhinitis and allergies to plant products according to the patient Other Placebo Intervention group: After surgery in the recovery room, while the patient is is conscious , before performing the intervention, 1- pain and physiological parameters are measured. 2-The researcher, Citrus Aurantium solution pours on the pad 2 * 2(0.4 ml ),the pad is taken a distance of 5 cm from the nose up to ten breaths and then the pad was attached to the patient's collar, after half an hour, pain and physiological measurements are checked and recorded. 3-After transferring the patient from the recovery room to the intensive care unit while the pad is attached to the patient's collar, one hour after the second recording, the pain and physiological criteria are checked and recorded . Control group: After surgery in the recovery room, while the patient is is conscious , before performing the intervention, 1- pain and physiological parameters are measured. 2-The researcher,placebo solution pours on the pad 2 * 2(0.4 ml ), the pad is taken a distance of 5 cm from the nose up to ten breaths and then the pad was attached to the patient's collar, after half an hour, pain and physiological measurements are checked and recorded. 3-After transferring the patient from the recovery room to the intensive care unit while the pad is attached to the patient's collar, one hour after the second recording, the pain and physiological criteria are checked and recorded . Pain. Timepoint: Before intervention . Half an hour after the intervention and one and a half hours after the intervention. Method of measurement: Visual analog scale for pain. Pulse - respiration- Blood Pressure ( systolic and diastolic). Timepoint: Before intervention . Half an hour after the intervention and one and a half hours after the intervention. Method of measurement: records on monitor. Shahed University Approved 2020-04-28 Shahed university Persian Gulf High Way Shahed university Tehran Tehran Iran (Islamic Republic of)