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IRCT20210501051142N9 IRCT 2023-02-28 Islamic Azad University, Khomein branch Comparison of the effect of violet flower and evening primrose flower on the anxiety Comparison of the effect of violet flower and evening primrose flower on the anxiety of menopausal women 2023-03-05 anticipated 72 Complete https://irct.ir/trial/68482 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Menopausal women are assigned to two intervention groups and one control group based on the randomization sequence that will be generated in advance, which is unpredictable and its arrangement is completely random. To allocate the samples, the block randomization method with the size of 3 and 6 blocks will be used, so that by using the software for generating random numbers in the block method, a randomization sequence will be generated according to the sample size required for the three groups. First, all the modes in which the 3 letters A, B and C can be put together in blocks of 3 and 6 are generated, then a block is randomly selected by placing it among the blocks and the layout pattern in that block will be used to allocate women. Finally this block will be placed in the main container and another block will be selected again. Blocks of 3 and 6 will all be in the same container. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups that the researcher will not be able to predict which group the next person will be in, Blinding description: The data analyzer will not know how the samples are placed in the intervention and control groups. Other people in the study will be aware of this placement. N/A Anxiety. Intervention 1: Intervention group 1: In the first intervention group (violet flower syrup), women will consume 5 ml of violet flower syrup twice a day (in the morning after waking up and at night before going to bed) for one month. At the beginning and end of the study, the Spielberger questionnaire, and the depression, anxiety and stress scale-21 form are completed by the menopausal women of all three groups, and their anxiety level is determined based on this. Intervention 2: Intervention group 2: In the second intervention group (evening primrose flower), postmenopausal women will consume 1 gram of evening primrose flower syrup twice a day (once in the morning and once at night with a glass of water) for one month. At the beginning and end of the study, the Spielberger questionnaire, and the depression, anxiety and stress scale-21 form are completed by the menopausal women of all three groups, and their anxiety level is determined based on this. Intervention 3: Control group: In this period, they do not receive this intervention and only fill the Spielberger questionnaire and the depression, anxiety and stress-21 scale form at the beginning and end of the study. Yes - There is a plan to make this available What will be shared: Only the part of the data related to the original outcome will be able to be shared. When: since the spring of 2023 To whom: Researchers and students in this field Conditions: In order to reduce the anxiety level of menopausal women Where to obtain: Vice chancellor for education and research, Khomein Azad university How to obtain: These documents will be available on the website of Khomein Azad university. Comments:
public Zeynab Beheshti
University campus, Daneshgah Blvd., Khomein
Khomein Iran (Islamic Republic of) ۳۸۸۱۶۱۳۴۸۵ +98 86 4633 7801 golmehrsherafati@gmail.com Islamic Azad University, Khomein branch scientific Zeynab Beheshti
University campus, Daneshgah Blvd., Khomein
Khomein Iran (Islamic Republic of) ۳۸۸۱۶۱۳۴۸۵ +98 86 4633 7801 golmehrsherafati@gmail.com Islamic Azad University, Khomein branch Iran (Islamic Republic of) Willingness to participate in the study Having at least reading and writing literacy Menopause (at least 12 months of spontaneous cessation of menstruation) Age 40-65 years 40 years 65 years Female Preventing the patient from taking herbal medicines Being admitted to the hospital The occurrence of a severe stressful event before entering the intervention (death of relatives, separation from spouse, sick person in the family, dismissal and bankruptcy) F06.4 Anxiety disorder due to known physiological condition Other Other Other Intervention group 1: In the first intervention group (violet flower syrup), women will consume 5 ml of violet flower syrup twice a day (in the morning after waking up and at night before going to bed) for one month. At the beginning and end of the study, the Spielberger questionnaire, and the depression, anxiety and stress scale-21 form are completed by the menopausal women of all three groups, and their anxiety level is determined based on this. Intervention group 2: In the second intervention group (evening primrose flower), postmenopausal women will consume 1 gram of evening primrose flower syrup twice a day (once in the morning and once at night with a glass of water) for one month. At the beginning and end of the study, the Spielberger questionnaire, and the depression, anxiety and stress scale-21 form are completed by the menopausal women of all three groups, and their anxiety level is determined based on this. Control group: In this period, they do not receive this intervention and only fill the Spielberger questionnaire and the depression, anxiety and stress-21 scale form at the beginning and end of the study. Anxiety rate. Timepoint: Before the intervention and twice after the start of the first intervention (on the 15th and 30th days of the intervention), the level of anxiety of each patient is measured. Method of measurement: At the beginning and end of the study, the demographic questionnaire, the Spielberger questionnaire, and the depression, anxiety and stress scale-21 form are completed by the menopausal women of all three groups, and their anxiety level is determined based on this. Islamic Azad University, Khomein branch Approved 2022-11-22 Ethics committee of faculty of medical sciences, Aligudarz Azad university Daneshgah square, Velayat Blvd., Aligudarz, Lorestan province Aligudarz Lorestan Iran (Islamic Republic of)