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IRCT20231211060336N1 IRCT 2023-12-25 Shiraz University of Medical Sciences A comparative assessment of the effect of aromatherapy with Citrus Aurantium and vanilla essence on pain intensity, blood pressure and perceived stress in adolescents undergoing appendectomy. Comparative assessment of the effect of aromatherapy with Citrus Aurantium and Vanilla essence on pain intensity, blood pressure and perceived postoperative stress in adolescents undergoing appendectomy 2024-01-21 anticipated 75 Complete https://irct.ir/trial/74427 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples are selected from eligible individuals based on entry criteria; Then they are divided into three groups using the permuted block method; In order to balance and divisible the number of blocks and each block is a multiple of three, a sample size of 81 people is considered and finally people will be allocated in 9 blocks of 9 blocks. 0001: A 0003: A 0005: B 0007: A 0009: C 0002: C 0004: B 0006: B 0008: C ________________________________________ 0010: A 0012: B 0014: B 0016: A 0018: C 0011: B 0013: C 0015: C 0017: A ________________________________________ 0019: B 0021: A 0023: C 0025: A 0027: B 0020: C 0022: C 0024: A 0026: B ________________________________________ 0028: C 0030: B 0032: B 0034: C 0036: A 0029: A 0031: A 0033: C 0035: B ________________________________________ 0037: A 0039: B 0041: C 0043: B 0045: A 0038: C 0040: B 0042: A 0044: C ________________________________________ 0046: B 0048: A 0050: B 0052: B 0054: A 0047: C 0049: C 0051: A 0053: C ________________________________________ 0055: B 0057: C 0059: A 0061: C 0063: B 0056: B 0058: A 0060: A 0062: C ________________________________________ 0064: A 0066: B 0068: C 0070: C 0072: B 0065: A 0067: B 0069: A 0071: C ________________________________________ 0073: C 0075: A 0077: B 0079: B 0081: A 0074: A 0076: C 0078: B 0080: C ________________________________________ 0082: A 0084: A 0086: B 0088: C 0090: C 0083: B 0085: A 0087: C 0089: B ________________________________________, Blinding description: Only the participants did not know which group they were placed in and whether they were prescribed aromatherapy or a placebo. 0 (exploratory trials) Intensity of pain, blood pressure and perceived stress after the operation of adolescents undergoing appendectomy surgery. Intervention 1: Intervention group1:A group of 25 people is selected to conduct a trial with Citrous Aurantium essential oil by random sampling method (permutation block). Spring orange extract with a concentration of 0.1% in 10 cc (preparation and standardization of spring orange extract, by the traditional medicine pharmacy team of Shiraz University of Medical Sciences Faculty of Pharmacy and with the approval of one of the faculty members of the Faculty of Pharmacy, affiliated to Shiraz University of Medical Sciences. ) in the amount of 2 ml using a dropper on a standard and clean eye pad and the pad is placed inside a suitable can and at the time of entering the ward (first pain measurement), 3 and 6 hours after the operation, in A distance of 30 cm from the child's nose is placed and the child is asked to take three deep breaths. Repetition of aromatherapy every 3 hours is appropriate to prevent normalization of the smell inhaled from the scent and to renew its smell in order to be effective. All pads are kept in a closed box between times of use; It should be noted that the pads used are only for one patient. After the patient enters the pediatric surgery department, the patient's blood pressure will be measured, and then the McGill pain questionnaire and the depression, anxiety, and stress questionnaire will be completed, and after that, the aromatherapy intervention will be performed for the first time; One hour after the first intervention, blood pressure will be measured for the second time and questionnaires will be completed; Also, three hours after the operation, the intervention is performed again, and questionnaires are completed and blood pressure measurement is done after one hour. After six hours of surgery, the intervention will be done for the last time, and one hour after that, questionnaires will be completed and the patient's blood pressure will be measured and recorded. Medical and nursing care will be performed according to routine. Data are collected and analyzed using SPSS software and statistical tests. Intervention 2: Intervention group2: A group of 25 people is selected to conduct a trial with Vanilla essence using a random sampling method (permutation block). Vanilla extract with a concentration of 10 mg in 10 cc (preparation and standardization of vanilla extract by the traditional medicine pharmacy team of the Faculty of Pharmacy of the University of Medical Sciences Shiraz and with the approval of one of the faculty members of the Faculty of Pharmacy, affiliated to Shiraz University of Medical Sciences) in the amount of 2 ml was poured on a clean standard eye pad using a dropper and the pad was placed inside a suitable can. and at the time of entering the ward (first pain measurement), 3 and 6 hours after the operation, it is placed at a distance of 30 cm from the child's nose and the child is asked to take three deep breaths. Repetition of aromatherapy every 3 hours is appropriate to prevent normalization of the smell inhaled from the scent and to renew its smell in order to be effective. All pads are kept in a closed box between times of use; It should be noted that the pads used are only for one patient. After the patient enters the pediatric surgery department, the patient's blood pressure will be measured, and then the McGill pain questionnaire and the depression, anxiety, and stress questionnaire will be completed, and after that, the aromatherapy intervention will be performed for the first time; One hour after the first intervention, blood pressure will be measured for the second time and questionnaires will be completed; Also, three hours after the operation, the intervention is performed again, and questionnaires are completed and blood pressure measurement is done after one hour. After six hours of surgery, the intervention will be done for the last time, and one hour after that, questionnaires will be completed and the patient's blood pressure will be measured and recorded. Medical and nursing care will be performed according to routine. Data are collected and analyzed using SPSS software and statistical tests. Intervention 3: Control group: Control group: In the control group, Paraffin is used as a placebo. A group of 25 people is selected to conduct a trial with paraffin as a placebo by random sampling method (permutation block). Preparation and standardization of paraffin by the traditional medicine pharmacy team of Shiraz University of Medical Sciences and with the approval of one of the professors. Scientific Faculty of Pharmacy, affiliated to Shiraz University of Medical Sciences, 2 ml is poured on a standard and clean eye pad using a dropper, and the pad is placed inside a suitable can and at the time of entering the department The first pain measurement), 3 and 6 hours after the operation, is placed at a distance of 30 cm from the child's nose and the child is asked to take three deep breaths. Repetition of aromatherapy every 3 hours. It should be noted that the pads used are only for one patient. After the patient enters the pediatric surgery department, the patient's blood pressure will be measured, and then the McGill pain questionnaire and the depression, anxiety, and stress questionnaire will be completed, and after that, the aromatherapy intervention will be performed for the first time; One hour after the first intervention, blood pressure will be measured for the second time and questionnaires will be completed; Also, three hours after the operation, the intervention is performed again, and questionnaires are completed and blood pressure measurement is done after one hour. After six hours of surgery, the intervention will be done for the last time, and one hour after that, questionnaires will be completed and the patient's blood pressure will be measured and recorded. Medical and nursing care will be performed according to routine. Data are collected and analyzed using SPSS software and statistical tests. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to the main outcomes, which can be shared after de-identifying individuals, will be shared. Data related to study outcomes, such as the effects of extracts on pain intensity, blood pressure, and perceived stress after Appendectomy surgery in adolescents hospitalized in the pediatric surgery department. When: The access period starts 6 months after the results are published. To whom: Researchers working in universities Conditions: Requesting the use of documents is unimpeded for researchers. Where to obtain: To receive documents, use the following email. Parisahajimohammad71@yahoo.com How to obtain: After the university researchers send the request to the mentioned email address, a brief description of the applicant should also be sent; after reviewing the application, if there are no problems, the documents will be sent. Comments: -
public Parisa Haji mohammadi ghahnavieh
Shariati Street، Dariun Town، Shiraz City، Fars Province
Shiraz Iran (Islamic Republic of) 7146135415 +98 913 335 3728 p.hajimohammadi.sums@gmail.com Shiraz University of Medical Sciences scientific Parisa Haji mohammadi ghahnavieh
Shariati Street، Dariun Town، Shiraz City، Fars Province
Shiraz Iran (Islamic Republic of) 7146135415 +98 913 335 3728 p.hajimohammadi.sums@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age between 11 and 18 years Absence of cognitive and mental problems based on the opinion of a specialist doctor No history of allergy to scents or herbal substances based on parents' statements Hospitalization due to appendectomy surgery 11 years 18 years Both Failure to continue participating in the study Death of the patient After the operation for any reason Incomplete completion of questionnaires Adolescent patients with olfactory problems Changes in the patient's level of consciousness The need to use mechanical ventilation devices for the patient Treatment - Other Treatment - Other Other Intervention group1:A group of 25 people is selected to conduct a trial with Citrous Aurantium essential oil by random sampling method (permutation block). Spring orange extract with a concentration of 0.1% in 10 cc (preparation and standardization of spring orange extract, by the traditional medicine pharmacy team of Shiraz University of Medical Sciences Faculty of Pharmacy and with the approval of one of the faculty members of the Faculty of Pharmacy, affiliated to Shiraz University of Medical Sciences. ) in the amount of 2 ml using a dropper on a standard and clean eye pad and the pad is placed inside a suitable can and at the time of entering the ward (first pain measurement), 3 and 6 hours after the operation, in A distance of 30 cm from the child's nose is placed and the child is asked to take three deep breaths. Repetition of aromatherapy every 3 hours is appropriate to prevent normalization of the smell inhaled from the scent and to renew its smell in order to be effective. All pads are kept in a closed box between times of use; It should be noted that the pads used are only for one patient. After the patient enters the pediatric surgery department, the patient's blood pressure will be measured, and then the McGill pain questionnaire and the depression, anxiety, and stress questionnaire will be completed, and after that, the aromatherapy intervention will be performed for the first time; One hour after the first intervention, blood pressure will be measured for the second time and questionnaires will be completed; Also, three hours after the operation, the intervention is performed again, and questionnaires are completed and blood pressure measurement is done after one hour. After six hours of surgery, the intervention will be done for the last time, and one hour after that, questionnaires will be completed and the patient's blood pressure will be measured and recorded. Medical and nursing care will be performed according to routine. Data are collected and analyzed using SPSS software and statistical tests. Intervention group2: A group of 25 people is selected to conduct a trial with Vanilla essence using a random sampling method (permutation block). Vanilla extract with a concentration of 10 mg in 10 cc (preparation and standardization of vanilla extract by the traditional medicine pharmacy team of the Faculty of Pharmacy of the University of Medical Sciences Shiraz and with the approval of one of the faculty members of the Faculty of Pharmacy, affiliated to Shiraz University of Medical Sciences) in the amount of 2 ml was poured on a clean standard eye pad using a dropper and the pad was placed inside a suitable can. and at the time of entering the ward (first pain measurement), 3 and 6 hours after the operation, it is placed at a distance of 30 cm from the child's nose and the child is asked to take three deep breaths. Repetition of aromatherapy every 3 hours is appropriate to prevent normalization of the smell inhaled from the scent and to renew its smell in order to be effective. All pads are kept in a closed box between times of use; It should be noted that the pads used are only for one patient. After the patient enters the pediatric surgery department, the patient's blood pressure will be measured, and then the McGill pain questionnaire and the depression, anxiety, and stress questionnaire will be completed, and after that, the aromatherapy intervention will be performed for the first time; One hour after the first intervention, blood pressure will be measured for the second time and questionnaires will be completed; Also, three hours after the operation, the intervention is performed again, and questionnaires are completed and blood pressure measurement is done after one hour. After six hours of surgery, the intervention will be done for the last time, and one hour after that, questionnaires will be completed and the patient's blood pressure will be measured and recorded. Medical and nursing care will be performed according to routine. Data are collected and analyzed using SPSS software and statistical tests. Control group: Control group: In the control group, Paraffin is used as a placebo. A group of 25 people is selected to conduct a trial with paraffin as a placebo by random sampling method (permutation block). Preparation and standardization of paraffin by the traditional medicine pharmacy team of Shiraz University of Medical Sciences and with the approval of one of the professors. Scientific Faculty of Pharmacy, affiliated to Shiraz University of Medical Sciences, 2 ml is poured on a standard and clean eye pad using a dropper, and the pad is placed inside a suitable can and at the time of entering the department The first pain measurement), 3 and 6 hours after the operation, is placed at a distance of 30 cm from the child's nose and the child is asked to take three deep breaths. Repetition of aromatherapy every 3 hours. It should be noted that the pads used are only for one patient. After the patient enters the pediatric surgery department, the patient's blood pressure will be measured, and then the McGill pain questionnaire and the depression, anxiety, and stress questionnaire will be completed, and after that, the aromatherapy intervention will be performed for the first time; One hour after the first intervention, blood pressure will be measured for the second time and questionnaires will be completed; Also, three hours after the operation, the intervention is performed again, and questionnaires are completed and blood pressure measurement is done after one hour. After six hours of surgery, the intervention will be done for the last time, and one hour after that, questionnaires will be completed and the patient's blood pressure will be measured and recorded. Medical and nursing care will be performed according to routine. Data are collected and analyzed using SPSS software and statistical tests. Pain intensity. Timepoint: Pain measurement is performed when the patient enters the surgery department (before the intervention),1, 3 and 6 hours after the first intervention. Method of measurement: McGill Pain Assessment Questionnaire. Blood pressure. Timepoint: Blood pressure is measured when the patient enters the surgery ward (before the intervention),1, 3 and 6 hours after the first intervention. Method of measurement: Mercury sphygmomanometer. Perceived stress. Timepoint: Perceived stress is measured using the depression, anxiety, and stress scale when the patient enters the surgery ward (before the intervention) and 1, 3, 6 hours after the first intervention. Method of measurement: Depression, anxiety, stress scale(DASS-21). Shiraz University of Medical Sciences Approved 2023-11-11 Ethics Committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)