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IRCT20200926048842N4 IRCT 2023-07-08 Semnan University of Medical Sciences Effect of rose and lavender aromatherapy on pain intensity and treatment of colorectal cancer under chemotherapy A comparative study of the effects of rose water aromatherapy and lavender aromatherapy on the intensity of pain and fatigue of colorectal cancer patients undergoing chemotherapy 2023-07-11 anticipated 64 Complete https://irct.ir/trial/71028 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: Sampling will be done by the available method. Every patient with colorectal cancer referring to Kausar (Semnan city) and Bahar (Shahroud city) hospitals who meets the inclusion criteria should be included in the study. Then the selected patients are cross-divided into two groups (A, B). In this way, first, envelopes with group names are prepared for the total number of study subjects and randomly arranged and selected by reference and selection of individuals, one of the cards will be identified, which will determine the individual's group. Was. According to random sampling, the research samples will have an equal chance to be selected in two groups. N/A Colorectal cancer. Intervention 1: First intervention group: At first, the demographic information form, and visual pain level (VAS) and fatigue level (MFI) questionnaires will be completed for patients in group A. Then these people will be subjected to inhalation aromatherapy intervention with rose essence in separate rooms individually. The interventionist was present in the chemotherapy department of the mentioned hospitals, and for the participants in this group, during a session of 4:30 hours from the moment of starting the chemotherapy, 5 drops of the essential oil of the rose flower provided by Gulabgiri Kashan Company with He will pour the prepared 1.5% concentration on a piece of cotton and place it on the collar of the patient's clothes at a distance of about 20 cm from the nose. The cotton piece remains in place for 4:30 hours during chemotherapy. Again, the level of pain and fatigue of the patients will be completed based on the mentioned questionnaires in the period of thirty minutes, one hour and three hours from the start of the aromatherapy intervention for this group of patients. Then the intervention is washed out for a week so that the effects of rose water aroma therapy in this group disappear. After that, the visual pain level (VAS) and fatigue level (MFI) questionnaires will be completed again for group A patients. In the following, these people under the intervention of inhalation aroma therapy with lavender essential oil with a concentration of 1.5% prepared by Barij Essential Oil Company of Kashan will pour 5 drops of the above scent on a piece of cotton and put it on the collar of the patient's clothes with about 20 cm meters away from the nose. The cotton piece remains in place for 4:30 hours during chemotherapy. Again, the level of pain and fatigue of the patients will be completed based on the mentioned questionnaires in the period of thirty minutes, one hour and three hours from the start of the aromatherapy intervention for this group of patients. Intervention 2: The second intervention group: At first, the demographic information form, and visual pain level (VAS) and fatigue level (MFI) questionnaires will be completed for patients in group B. Then these people will be subjected to inhalation aromatherapy intervention with lavender essential oil in separate rooms individually. The interventionist was present in the chemotherapy department of the mentioned hospitals, and for the participants in this group, during a session of 4:30 hours from the moment of the start of chemotherapy, 5 drops of lavender scent, which was provided by Barij Essan Company of Kashan with He will pour the prepared 1.5% concentration on a piece of cotton and place it on the collar of the patient's clothes at a distance of about 20 cm from the nose. The cotton piece remains in place for 4:30 hours during chemotherapy. Again, the level of pain and fatigue of the patients will be completed based on the mentioned questionnaires in the period of thirty minutes, one hour and three hours from the start of the aromatherapy intervention for this group of patients. Then the intervention is washed out for a week so that the effects of lavender aromatherapy in this group disappear. After that, the visual pain level (VAS) and fatigue level (MFI) questionnaires will be completed again for group B patients. In the following, these people under the intervention of inhalation aroma therapy with rose essence with a concentration of 1.5%, prepared by Gulab Giri Kashan Company, will pour 5 drops of the above scent on a piece of cotton and put it on the collar of the patient's clothes with about 20 cm meters away from the nose. The cotton piece remains in place for 4:30 hours during chemotherapy. Again, the level of pain and fatigue of the patients will be completed based on the mentioned questionnaires in the period of thirty minutes, one hour and three hours from the start of the aromatherapy intervention for this group of patients. 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 There is no more information
public Sajad Salehipour
No. 19, Alley 12, Lebanon Martyrs Street, Tehran Avenue
Shahroud Iran (Islamic Republic of) 3619676483 +98 23 3237 3188 ssn.shahroud@yahoo.com Semnan University of Medical Sciences scientific Sajad Salehipour
No. 19, Alley 12, Lebanon Martyrs Street, Tehran Avenue
Shahroud Iran (Islamic Republic of) 3619676483 +98 23 3237 3188 ssn.shahroud@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Insensitivity to plants and their extracts according to the person's previous history Colorectal cancer has been definitively diagnosed by a hematologist and oncologist. Undergoing the first cycle of chemotherapy up to a maximum of the fifth cycle of chemotherapy Having a pain intensity score of at least 3 based on the questionnaire (VAS) No smoking, drugs and alcohol Not suffering from other known chronic diseases such as heart-pulmonary diseases, blood pressure and diabetes Not using perfume or cologne before or during the intervention Not having an olfactory disorder and also having a cold and nasal congestion that should affect the sense of smell Absence of mental disorders Not receiving natural painkillers 3 hours before the start or during the intervention Having a history of surgery in less than 3 months Having hemoglobin of at least 8gr/dl 18 years 70 years Both Use of other pain relief methods during the study Refusal to continue participating in the study The patient's lack of awareness colorectal cancer Decreased level of alertness while studying Occurrence of skin and eye allergies during study The occurrence of severe physical complications caused by the disease death of the patient suffering from diseases characterized by fatigue (multiple sclerosis, fibromyalgia, AIDS, joint rheumatism) Presence of perceptual disorders related to smell (olfactory hallucinations) C19 Malignant neoplasm of rectosigmoid junction Rehabilitation Rehabilitation First intervention group: At first, the demographic information form, and visual pain level (VAS) and fatigue level (MFI) questionnaires will be completed for patients in group A. Then these people will be subjected to inhalation aromatherapy intervention with rose essence in separate rooms individually. The interventionist was present in the chemotherapy department of the mentioned hospitals, and for the participants in this group, during a session of 4:30 hours from the moment of starting the chemotherapy, 5 drops of the essential oil of the rose flower provided by Gulabgiri Kashan Company with He will pour the prepared 1.5% concentration on a piece of cotton and place it on the collar of the patient's clothes at a distance of about 20 cm from the nose. The cotton piece remains in place for 4:30 hours during chemotherapy. Again, the level of pain and fatigue of the patients will be completed based on the mentioned questionnaires in the period of thirty minutes, one hour and three hours from the start of the aromatherapy intervention for this group of patients. Then the intervention is washed out for a week so that the effects of rose water aroma therapy in this group disappear. After that, the visual pain level (VAS) and fatigue level (MFI) questionnaires will be completed again for group A patients. In the following, these people under the intervention of inhalation aroma therapy with lavender essential oil with a concentration of 1.5% prepared by Barij Essential Oil Company of Kashan will pour 5 drops of the above scent on a piece of cotton and put it on the collar of the patient's clothes with about 20 cm meters away from the nose. The cotton piece remains in place for 4:30 hours during chemotherapy. Again, the level of pain and fatigue of the patients will be completed based on the mentioned questionnaires in the period of thirty minutes, one hour and three hours from the start of the aromatherapy intervention for this group of patients. The second intervention group: At first, the demographic information form, and visual pain level (VAS) and fatigue level (MFI) questionnaires will be completed for patients in group B. Then these people will be subjected to inhalation aromatherapy intervention with lavender essential oil in separate rooms individually. The interventionist was present in the chemotherapy department of the mentioned hospitals, and for the participants in this group, during a session of 4:30 hours from the moment of the start of chemotherapy, 5 drops of lavender scent, which was provided by Barij Essan Company of Kashan with He will pour the prepared 1.5% concentration on a piece of cotton and place it on the collar of the patient's clothes at a distance of about 20 cm from the nose. The cotton piece remains in place for 4:30 hours during chemotherapy. Again, the level of pain and fatigue of the patients will be completed based on the mentioned questionnaires in the period of thirty minutes, one hour and three hours from the start of the aromatherapy intervention for this group of patients. Then the intervention is washed out for a week so that the effects of lavender aromatherapy in this group disappear. After that, the visual pain level (VAS) and fatigue level (MFI) questionnaires will be completed again for group B patients. In the following, these people under the intervention of inhalation aroma therapy with rose essence with a concentration of 1.5%, prepared by Gulab Giri Kashan Company, will pour 5 drops of the above scent on a piece of cotton and put it on the collar of the patient's clothes with about 20 cm meters away from the nose. The cotton piece remains in place for 4:30 hours during chemotherapy. Again, the level of pain and fatigue of the patients will be completed based on the mentioned questionnaires in the period of thirty minutes, one hour and three hours from the start of the aromatherapy intervention for this group of patients. Pain intensity. Timepoint: It is before the start of the intervention and thirty minutes and one hour and three hours after the intervention. Method of measurement: The visual scale for measuring pain intensity is a 10 cm ruler, on the left end of which the word no pain is written and on the right end the word the most severe state of pain is written. According to the amount of pain in the last 48 hours, the person puts a mark on the continuum; Then the amount of pain is measured by the researcher using the visual pain intensity measurement scale (VAS) which is standardized for pain measurement. The visual scale for measuring pain intensity from zero to ten is divided as follows: 0-1: (no pain) / 2-3: (little pain) / 4-5: (extreme pain) / 6-7: (pain) very bad)/ 8-9: (maximum pain) and 10 (unbearable pain). Fatigue rate. Timepoint: It is before the start of the intervention and thirty minutes and one hour and three hours after the intervention. Method of measurement: The questionnaire (MFI) consists of 20 items and 5 subscales of general fatigue (4 questions), physical fatigue (4 questions), decreased activity (4 questions), decreased motivation (4 questions) and mental fatigue (4 questions), which It is used to measure fatigue. The scoring of the questionnaire is on a 5-option Likert scale from 1 = yes, completely true to 5 = no, completely false. Questions number 2, 5, 9, 10, 13, 14, 16, 17, 18, 19 are graded in reverse order and are graded as 5 completely correct to 1 completely incorrect. To get the overall score of the questionnaire, the scores of all items are added together. The total score of each field is 4-20 and the total score of fatigue determined by the sum of the scores of the fields can be between 20-100. A higher score indicates greater fatigue. Semnan University of Medical Sciences Approved 2023-06-26 Ethics committee of Semnan University of Medical Sciences Headquarters of Semnan University of Medical Sciences and Health Services, Basij Blvd Semnan Semnan Iran (Islamic Republic of)