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IRCT20121208011692N4 IRCT 2025-02-18 Yasouj University of Medical Sciences The survey of the effect of aromatherapy on patients undergoing chemotherapy The survey of the effect of aromatherapy with Rosa damascena essence on chemotherapy-induced nausea and vomiting: a randomized clinical trial 2025-02-19 anticipated 62 Complete https://irct.ir/trial/81624 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Participants eligible for the study will be selected through convenience sampling and will be randomly assigned to one of the two intervention and control groups through block random assignment. The total number of samples is 62, with 31 in each group, Randomization description: Participants eligible for the study will be selected using convenience sampling and will be randomly assigned to one of two intervention or control groups through block random assignment. First, we calculate the number of samples in each block by multiplying the number of study groups (two groups) by 2, resulting in a block size of 4. Next, we determine the total number of arrangements of individuals using a factorial calculation (1×2×3×4=4!=24), which indicates there will be 24 different blocks. Each block will contain 4 participants (2 from each group), arranged differently. The blocks will be randomly selected for placement, meaning that when a block is chosen, it will contain those 4 participants. The allocation method is clearly defined. The potential arrangements of participants within the blocks are as follows: ABCD, ABDC, ACBD, ACDB, ADBC, ADCB, BACD, BADC, BCAD, BCDA, BDAC, BDCA, CABD, CADB, CBAD, CBDA, CDAB, CDBA, DABC, DACB, DBAC, DBCA, DCAB, and DCBA. The group labels will be randomly assigned and drawn, with A representing the intervention group, while B and C designate the control group, and D also represents the intervention group. Each participant will be given a code, which corresponds with the block random allocation list, enabling them to be assigned to either the intervention or control group. 3 Cancer. Intervention group: In the intervention group, aromatherapy with Rosa damascena essence will be performed alongside routine treatments. The intervention will be carried out from the day of chemotherapy until the third day after chemotherapy and will continue for 3 consecutive cycles. To ensure that the participants are not allergic to the essential oil, a skin test will be performed on all patients in the intervention group. In this test, a drop of Rosa damascena essence with a concentration of 40% will be placed on the back of the patient's hand. After two minutes of contact with the skin, the back of the patient's hand will be examined for any allergic reaction (such as redness, hives, itching, etc.). Only those who do not have any allergy symptoms will be included in the study. In the next step, a cotton ball soaked in five drops of Rosa damascena essence will be placed 30 centimeters from the patient's nose. Patients are advised to breathe normally twice a day, for 20 minutes each time, and continue this process for three consecutive days.. Yes - There is a plan to make this available What will be shared: Data can be shared after de-identifying individuals. When: Access period starts 6 months after results are published. To whom: For scientific researchers Conditions: ... Where to obtain: 09173411267 afrasiabifar.ardashir@yums.ac.ir How to obtain: By email and phone call Comments:
public Afrasiabifar Ardashir
Yasuj University of Medical Sciences
Yasuj Iran (Islamic Republic of) 7591615486 +98 74 3323 4115 afrasiabifar.ardashir@yums.ac.ir Yasouj University of Medical Sciences scientific Afrasiabifar Ardashir
Yasuj University of Medical Sciences
Yasuj Iran (Islamic Republic of) 7591615486 +98 74 3323 4115 afrasiabifar.ardashir@yums.ac.ir Yasouj University of Medical Sciences Iran (Islamic Republic of) Definite diagnosis of cancer by an oncologist Completed at least one course of chemotherapy with antiemetic chemotherapy drugs including cyclophosphamide, cisplatin, carboplatin and doxorubicin in a single or multiple regimen No history of nausea and vomiting for reasons other than chemotherapy No digestive problems or diarrhea Age over 18 Not pregnant or breastfeeding Not taking sedatives and antidepressants 18 years no limit Both Lack of study inclusion criteria Unwillingness to participate in the study R97.1 Elevated cancer antigen 125 [CA 125] Treatment - Drugs Intervention group: In the intervention group, aromatherapy with Rosa damascena essence will be performed alongside routine treatments. The intervention will be carried out from the day of chemotherapy until the third day after chemotherapy and will continue for 3 consecutive cycles. To ensure that the participants are not allergic to the essential oil, a skin test will be performed on all patients in the intervention group. In this test, a drop of Rosa damascena essence with a concentration of 40% will be placed on the back of the patient's hand. After two minutes of contact with the skin, the back of the patient's hand will be examined for any allergic reaction (such as redness, hives, itching, etc.). Only those who do not have any allergy symptoms will be included in the study. In the next step, a cotton ball soaked in five drops of Rosa damascena essence will be placed 30 centimeters from the patient's nose. Patients are advised to breathe normally twice a day, for 20 minutes each time, and continue this process for three consecutive days. Chemotherapy-induced nausea and vomiting score on the MAT questionnaire. Timepoint: In 3 cycles of chemotherapy, 2 times per cycle (in the first 24 hours and after the first 24 hours after chemotherapy). Method of measurement: Multinational Association of Supportive Care in Cancer Antiemesis Tool. Yasouj University of Medical Sciences Approved 2025-01-29 Ethics committee of Yasuj University of Medical Sciences Yasuj University of Medical Sciences Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)