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IRCT20210220050418N2 IRCT 2023-10-11 Rasht University of Medical Sciences Comparison of the effects of lavender and citrus aurantium inhalation on the severity of primary dysmenorrhea Comparison of the effects of lavender and citrus aurantium inhalation on the severity of primary dysmenorrhea in female students: A randomized controlled trial 2023-11-22 anticipated 44 Complete https://irct.ir/trial/72916 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: The current research is a clinical trial of 3 groups (2 intervention groups and one control group). In this study, sampling will be done with the consecutive presence of the researcher in the dormitories of Guilan University of Medical Sciences in Rasht city during two stages. In the first stage, qualified people will be selected by Convenience sampling method, then the restricted randomization method of block randomization will be used and the design of permutation blocks with 6 samples in each block will be used. With this method, patients will be divided into three treatment groups by inhaling lavender essential oil, citrus aurantium and distilled water (as placebo or control), Randomization description: Random allocation software is used for randomization. In addition to simple randomization, these random sequence generation softwares are capable of generating random sequences using the blocking method. For concealment, we use random allocation concealment, which refers to the method used to perform a random sequence on the participants in the study, so that the allocated group is not known before the allocation of the individual. By using opaque envelopes sealed with a random sequence (Sequentially numbered, sealed, opaque envelopes), in this method, each of the generated random sequences is recorded on a card, and the cards inside the letter envelopes are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. N/A primary dysmenorrhea in female students. Intervention 1: Intervention group: After identifying the individuals, each of them is asked to record their pain intensity using the Visual Analogue Scale in the first and second cycles of the intervention. If the pain score is 5 or more than 5 in the first cycle before the intervention, the pain intensity of the people in the second cycle will also be measured by the researcher. If they have 5 or more points in two consecutive cycles, people will be included in the study. The pain intensity of people in the second cycle will be evaluated as the pain intensity before the intervention. The intervention of this research was carried out in the third and fourth menstrual cycle of the research units and the effect of inhaled drugs will be investigated. The people of the first intervention group will receive the scent of citrus aurantium, the people of the second intervention group will receive the scent of lavender, and the control group will receive the inhalation of distilled water. Citrus aurantium and lavender essential oils with a concentration of 25 μl/l are prepared in standard form and with the same quality in all bottles by Barij Essential Oil Company. In the inhalation aromatherapy group, 10 drops of essential oil of citrus aurantium or lavender, or 10 drops of distilled water are dripped into a cotton and the person is asked for 30 minutes (according to the studies done, the process of absorbing the essential oil and reaching the level Metabolites of lavender and citrus aurantium in the blood to an acceptable level (therapeutic effect level) takes an average of 30 minutes, the duration of aromatherapy in this study will be considered 30 minutes), at a distance of 20 cm from her nose and smell it. All three inhalation aromatherapy and control groups are asked to repeat the intervention the next day at the same time and record their pain intensity in the presence of the researcher on the third day of menstruation. The researcher's contact number will be provided to the participants to answer any questions and problems, so that they can contact the researcher if needed. Intervention 2: Intervention group: The second intervention group will receive lavender scent with a concentration of 25 μl/l, similar to the first group. Intervention 3: Control group: In this study, the control group will include students who have the conditions to enter the study, who will receive the same inhalation intervention as the test group with distilled water. Yes - There is a plan to make this available What will be shared: Basic and general data When: One year To whom: Faculty members of Shahid Beheshti School of Nursing and Midwifery, Rasht Conditions: In order to check the correctness of the data and having a written and approved request from the research assistant of Shahid Beheshti College of Nursing and Midwifery in Rasht Where to obtain: Shahid Beheshti College of Nursing and Midwifery in Rasht, as well as a written request from the plan administrator How to obtain: A written request from the plan administrator Comments:
public Zahra Bostani Khalesi
Shahid Beheshti College of Nursing and Midwifery, Student Street, Shahid Beheshti Highway
Rasht Iran (Islamic Republic of) 4146939814 +98 13 3355 5001 z_bostani@yahoo.com Rasht University of Medical Sciences scientific Zahra Bostani Khalesi
Shahid Beheshti College of Nursing and Midwifery, Student Street, Shahid Beheshti Highway
Rasht Iran (Islamic Republic of) 4146939814 +98 13 3355 5001 z_bostani@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) willingness and informed consent to participate in the research having a regular menstrual cycle with a duration of 2-6 days and an interval of 21-35 days between periods onset of menstruation before the age of 15 primary dysmenorrhea with a score of 5 or more in the Visual Analogue Scale of pain during two consecutive cycles age 18-25 years being single being Iranian lack of known mental or physical illness (according to the statements of the research participant) absence of gynecological disease (myoma, endometriosis, ovarian cyst , pelvic inflammatory disease, etc.) (according to the statements of the research participant) having a normal sense of smell no history of allergies 18 years 25 years Female not wanting to participating in the study having an allergy to citrus aurantium having an allergy to lavender N94.4 Primary dysmenorrhoea Rehabilitation Rehabilitation Other Intervention group: After identifying the individuals, each of them is asked to record their pain intensity using the Visual Analogue Scale in the first and second cycles of the intervention. If the pain score is 5 or more than 5 in the first cycle before the intervention, the pain intensity of the people in the second cycle will also be measured by the researcher. If they have 5 or more points in two consecutive cycles, people will be included in the study. The pain intensity of people in the second cycle will be evaluated as the pain intensity before the intervention. The intervention of this research was carried out in the third and fourth menstrual cycle of the research units and the effect of inhaled drugs will be investigated. The people of the first intervention group will receive the scent of citrus aurantium, the people of the second intervention group will receive the scent of lavender, and the control group will receive the inhalation of distilled water. Citrus aurantium and lavender essential oils with a concentration of 25 μl/l are prepared in standard form and with the same quality in all bottles by Barij Essential Oil Company. In the inhalation aromatherapy group, 10 drops of essential oil of citrus aurantium or lavender, or 10 drops of distilled water are dripped into a cotton and the person is asked for 30 minutes (according to the studies done, the process of absorbing the essential oil and reaching the level Metabolites of lavender and citrus aurantium in the blood to an acceptable level (therapeutic effect level) takes an average of 30 minutes, the duration of aromatherapy in this study will be considered 30 minutes), at a distance of 20 cm from her nose and smell it. All three inhalation aromatherapy and control groups are asked to repeat the intervention the next day at the same time and record their pain intensity in the presence of the researcher on the third day of menstruation. The researcher's contact number will be provided to the participants to answer any questions and problems, so that they can contact the researcher if needed. Intervention group: The second intervention group will receive lavender scent with a concentration of 25 μl/l, similar to the first group. Control group: In this study, the control group will include students who have the conditions to enter the study, who will receive the same inhalation intervention as the test group with distilled water. Measurable primary outcome: dysmenorrhea pain intensity, measured by the Visual Analogue Scale. Timepoint: Dysmenorrhea pain intensity is measured in 4 cycles, two menstrual cycles before the start of the intervention, and two menstrual cycles after the entry of the study subjects for the intervention. Method of measurement: After defining the groups, each of them is asked to record their pain intensity using the Visual Analogue Scale in the first and second cycles of the intervention. If the pain score is 5 or more than 5 in the first cycle before the intervention, the pain intensity of the people will be measured in the second cycle as well. If they have 5 or more points in two consecutive cycles, people will be included in the study. The pain intensity of people in the second cycle will be evaluated as the pain intensity before the intervention. The intervention of this research was carried out in the third and fourth menstrual cycle of the research units and the effect of inhaled drugs will be investigated. People are asked to record and inform the type, dosage and exact time of use if they take any painkillers at the time of study. In order to ensure that the intervention is performed after the maximum effect of the painkiller and to prevent its effect from interfering with the desired intervention, it is necessary to accurately record the time of use of each painkiller so that the aromatherapy intervention can be performed after the effectiveness of the painkiller is lost. In the third and fourth menstrual cycles of the study subjects, on the first and second days of the cycle, the intervention will be performed and on the third day, the pain intensity of the subjects will be recorded in the presence of the researcher (the subjects will be asked to inform the researcher of the time of menstruation and record their symptoms in the questionnaire). In this study, distilled water will be used as a placebo. Bottles containing distilled water and citrus aurantium and lavender essential oil have the same volume, shape and size and the letters A, B and C will be recorded on them, letter A corresponds to citrus aurantium, letter B lavender and letter C distilled water (as a control). To ensure that the units are not allergic to lavender and citrus aurantium, a skin test will be performed for all patients. In this way, a drop of 100% lavender essential oil (a product of Barij Essential Oil Company) will be poured on the inner surface of the patient's wrist and a bandage will be placed on it to prevent breathing, and after two minutes of skin contact, the location of the oil will be observed on the wrist. and if there are no signs of sensitivity (redness, hives, itching), the person will enter the study. In case of any allergy, the person will be referred to a specialist doctor. In order to equalize the two studied groups, distilled water will be tested in the placebo group as well. People in the intervention groups will receive the inhalation of citrus aurantium and lavender scent and the control group will receive inhalation with distilled water. citrus aurantium and lavender essential oils with a concentration of 25 μl/l are prepared in standard form and with the same quality in all bottles by Barij Essential Oil Company. In the inhalation aromatherapy group, 10 drops of essential oil of spring orange or lavender, or 10 drops of distilled water are dripped into a cotton and the person is asked for 30 minutes (according to the studies done, the process of absorbing the essential oil and reaching the level metabolites of lavender and citrus aurantium in the blood to an acceptable level (therapeutic effect level) takes an average of 30 minutes, the duration of aromatherapy in this study will be considered 30 minutes), at a distance of 20 cm from her nose and smell it. All three inhalation aromatherapy and control groups are asked to repeat the intervention the next day at the same time and record their pain intensity in the presence of the researcher on the third day of menstruation. The researcher's contact number will be provided to the participants to answer any questions and problems, so that they can contact the researcher if needed. Rasht University of Medical Sciences Approved 2023-02-15 Research Ethics Committees of Guilan university of medical sciences in front of 17 Shahrivar Hospital, Shahid Siyadati St., Namjo St., , Rasht Guilan Iran (Islamic Republic of)