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IRCT20210501051142N4 IRCT 2022-10-26 Arak University of Medical Sciences Evaluation of the effect of crocus sativus tea on anxiety level Evaluation of the effect of crocus sativus tea on anxiety level of nurses working in intensive care units 2022-10-02 anticipated 68 Complete https://irct.ir/trial/65378 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Nurses are divided into an intervention group and a control group based on the order of entry and the randomization sequence that is established in advance. The sequence is unpredictable and the arrangement is completely random. To allocate the samples, the block randomization method with the size of 6 blocks of 4 blocks will be used, so that by using the random number generation software in the block method, the randomization sequence will be produced according to the required sample size for two groups. At first, the sequence ABAB, ABBA, BBAA, BABA, BAAB, AABB is produced, then randomly and by placing among the blocks, a block is selected and the arrangement pattern in that block will be used to allocate nurses, then this block is placed in the main container and Another block will be selected again. 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 and participants will not know how the samples are placed in the intervention and control groups. N/A Anxiety level. Intervention 1: Intervention group: The intervention group is given tea containing 100 mg of saffron and 100 ml of water for 40 days. At the beginning of the study, demographic questionnaire and Spiel Berger questionnaire are completed by nurses. Based on the response to the Spiel Berger questionnaire, the level of primary anxiety of nurses is determined. Then, at the end of 40 days, the Spiel Berger questionnaire is completed again by the nurses, and all the dependent variables of the research are checked at the beginning and the end of the study, and according to the articles that have measured the level of anxiety with the Spiel Berger questionnaire, in this study, the level Overt anxiety is checked. Intervention 2: Control group: The control group was given a placebo containing 100 ml of water and two drops of saffron essential oil to flavor the water in such a way that it cannot be identified with the tea containing saffron for 40 days. The essential oil used was prepared by Magnolia Company, which is the largest company in the production of flavorings and essential oils in Iran, which started its activity in 2013. At the beginning of the study, demographic questionnaire and Spiel Berger questionnaire are completed by nurses. Based on the response to the Spiel Berger questionnaire, the level of primary anxiety of nurses is determined. Then, at the end of 40 days, the Spiel Berger questionnaire is completed again by the nurses, and all the dependent variables of the research are checked at the beginning and the end of the study, and according to the articles that have measured the level of anxiety with the Spiel Berger questionnaire, in this study, the level Overt anxiety is checked. 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 winter of 2023 To whom: Researchers and students in this field Conditions: In order to reduce the level of anxiety of the medical staff Where to obtain: Vice chancellor for education and research, Arak university of medical sciences How to obtain: These documents will be available on the website of Arak university of medical sciences. Comments:
public Mahbobeh Sajadi
University complex of the Great prophet, Basij square, Sardasht.
Arak Iran (Islamic Republic of) 3819693345 009886341735057 golmehrsherafati@gmail.com Arak University of Medical Sciences scientific Mahbobeh Sajadi
University complex of the Great prophet, Basij square, Sardasht.
Arak Iran (Islamic Republic of) 3819693345 009886341735057 golmehrsherafati@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Nurses who attend the ward only for 175 hours per month (mandatory hours). Not taking any sedative and anti-anxiety drugs 18 years 65 years Both Unwillingness to participate in the study Allergic to saffron Complications caused by the consumption of saffron The presence of any underlying disease Pregnancy F41.9 Anxiety disorder, unspecified Other Other Intervention group: The intervention group is given tea containing 100 mg of saffron and 100 ml of water for 40 days. At the beginning of the study, demographic questionnaire and Spiel Berger questionnaire are completed by nurses. Based on the response to the Spiel Berger questionnaire, the level of primary anxiety of nurses is determined. Then, at the end of 40 days, the Spiel Berger questionnaire is completed again by the nurses, and all the dependent variables of the research are checked at the beginning and the end of the study, and according to the articles that have measured the level of anxiety with the Spiel Berger questionnaire, in this study, the level Overt anxiety is checked. Control group: The control group was given a placebo containing 100 ml of water and two drops of saffron essential oil to flavor the water in such a way that it cannot be identified with the tea containing saffron for 40 days. The essential oil used was prepared by Magnolia Company, which is the largest company in the production of flavorings and essential oils in Iran, which started its activity in 2013. At the beginning of the study, demographic questionnaire and Spiel Berger questionnaire are completed by nurses. Based on the response to the Spiel Berger questionnaire, the level of primary anxiety of nurses is determined. Then, at the end of 40 days, the Spiel Berger questionnaire is completed again by the nurses, and all the dependent variables of the research are checked at the beginning and the end of the study, and according to the articles that have measured the level of anxiety with the Spiel Berger questionnaire, in this study, the level Overt anxiety is checked. Anxiety rate. Timepoint: Before the intervention and 40 days after the start of the first intervention, the anxiety level of each patient is measured. Method of measurement: At the beginning and end of the study, the demographic questionnaire and the Spiel Berger questionnaire were completed by the nurses of both groups and based on this, the anxiety level of nurses is determined. Arak University of Medical Sciences Approved 2022-05-15 Ethics committee of Arak university of medical sciences Arak university of medical sciences, Basij Sq., Sardasht region Arak Markazi Iran (Islamic Republic of)