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IRCT20220305054184N1 IRCT 2022-03-23 Kermanshah University of Medical Sciences Investigating the effect of aromatherapy of two essential oils of jasmine and bitter orange on the level of anxiety in children Investigating the effect of aromatherapy of two essential oils of jasmine and bitter orange on the level of anxiety in children referred to the clinic of Mohammad Kermanshahi Hospital in Kermanshah In a randomized clinical trial 2022-04-21 anticipated 120 Complete https://irct.ir/trial/62295 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, block randomization method with 6 blocks will be used. A random sequence will be created by an epidemiologist using the site https://www.sealedenvelope.com, and people who assign patients to groups will not be aware of the random sequence. Each person will be assigned a code in this method and only the epidemiologist will know which group these codes belong to. Therefore, hiding the random process will be fully observed; In addition, registration and assignment of patients to study groups will be done by the first and second implementers of the research project. Samples will be randomly assigned to three groups using block randomization method with 6 blocks. Blocking is usually used to balance the number of samples assigned to each of the groups studied. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. Blocking is done in two ways. In this method, the size of the blocks is randomly selected (for example, blocks 6, 8, 10 and 14 in each block with an equal number of each group). 3 Anxiety. Intervention 1: Intervention group 1: The substance used in this study in connection with intervention group 1 will contain jasmine essential oil. The electric fragrance diffuser will be used in the patients' presence space on the assigned days according to the sections mentioned). The device will start 30 minutes before the patient is present. Based on clinical experience and to receive essential oil with a constant medium concentration, 2 ml of essential oil will be used. The timer will be set to activate every 10 minutes for 2 minutes. To assess anxiety, children will first be interviewed using the face image scale (FIS) tool. The FIS scale consists of a row of five figures arranged from very happy to very dissatisfied. Children are asked to indicate which face best describes their feelings at that moment. This scale is scored by giving the value of one to the most positive face and five to the most negative face. One interview will be done before the intervention and the other after the intervention. In the next step, in order to increase the confidence and also to reduce the percentage of errors in execution and the results of the study, the child's cortisol level (measured with a commercial kit), heart rate and blood pressure will be measured by the doctor before and after the intervention. Intervention 2: Intervention group 2: The substance used in this study in connection with intervention group 2 will include bitter orange essential oil. An electric fragrance diffuser will be used in the patient's presence space (on assigned days according to the sections mentioned). The device will start 30 minutes before the patient is present. Based on clinical experience and to receive essential oil with a constant medium concentration, 2 ml of essential oil will be used. The timer will be set to activate every 10 minutes for 2 minutes. To assess anxiety, children will first be interviewed using the face image scale (FIS) tool. The FIS scale consists of a row of five figures arranged from very happy to very dissatisfied. Children are asked to indicate which face best describes their feelings at that moment. This scale is scored by giving the value of one to the most positive face and five to the most negative face. One interview will be done before the intervention and the other after the intervention. In the next step, in order to increase the confidence and also to reduce the percentage of errors in execution and the results of the study, the child's cortisol level (measured with a commercial kit), heart rate and blood pressure will be measured by the doctor before and after the intervention. Intervention 3: Control group: In relation to the control group in the study, in order to provide a basis for comparing the effect of aromatherapy on the intervention and control groups, this group is deprived of routine treatment, but in order to perform the study in equal conditions to assess anxiety, first interview with children. The face image scale (FIS) tool will be done. The FIS scale consists of a row of five figures arranged from very happy to very dissatisfied. Children are asked to indicate which face best describes their feelings at that moment. This scale is scored by giving the value of one to the most positive face and five to the most negative face. In the next step, in order to increase the confidence and also to reduce the percentage of errors in execution and the results of the study, the child's cortisol level (measured with a commercial kit), heart rate and blood pressure will be measured by the doctor before and after the intervention. 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 Its release schedule is not yet known
public Dr.Mohamad Reza Tohidi
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
Kermanshah Iran (Islamic Republic of) 6714869914 +98 83 3835 8943 tohidimohamadreza63@gmail.com Kermanshah University of Medical Sciences scientific Dr.Mohamad Reza Tohidi
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
Kermanshah Iran (Islamic Republic of) 6714869914 +98 83 3835 8943 tohidimohamadreza63@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Age 6 to 12 years Patient's consent to the use of clinical information in research purposes (in order to maintain the professional principles of research ethics) 6 years 12 years Both A person has cognitive problems or anxiety disorders Taking drugs that affect the central nervous system, with a sedative or anxiety relief effect F41 Other anxiety disorders Prevention Prevention Prevention Intervention group 1: The substance used in this study in connection with intervention group 1 will contain jasmine essential oil. The electric fragrance diffuser will be used in the patients' presence space on the assigned days according to the sections mentioned). The device will start 30 minutes before the patient is present. Based on clinical experience and to receive essential oil with a constant medium concentration, 2 ml of essential oil will be used. The timer will be set to activate every 10 minutes for 2 minutes. To assess anxiety, children will first be interviewed using the face image scale (FIS) tool. The FIS scale consists of a row of five figures arranged from very happy to very dissatisfied. Children are asked to indicate which face best describes their feelings at that moment. This scale is scored by giving the value of one to the most positive face and five to the most negative face. One interview will be done before the intervention and the other after the intervention. In the next step, in order to increase the confidence and also to reduce the percentage of errors in execution and the results of the study, the child's cortisol level (measured with a commercial kit), heart rate and blood pressure will be measured by the doctor before and after the intervention. Intervention group 2: The substance used in this study in connection with intervention group 2 will include bitter orange essential oil. An electric fragrance diffuser will be used in the patient's presence space (on assigned days according to the sections mentioned). The device will start 30 minutes before the patient is present. Based on clinical experience and to receive essential oil with a constant medium concentration, 2 ml of essential oil will be used. The timer will be set to activate every 10 minutes for 2 minutes. To assess anxiety, children will first be interviewed using the face image scale (FIS) tool. The FIS scale consists of a row of five figures arranged from very happy to very dissatisfied. Children are asked to indicate which face best describes their feelings at that moment. This scale is scored by giving the value of one to the most positive face and five to the most negative face. One interview will be done before the intervention and the other after the intervention. In the next step, in order to increase the confidence and also to reduce the percentage of errors in execution and the results of the study, the child's cortisol level (measured with a commercial kit), heart rate and blood pressure will be measured by the doctor before and after the intervention. Control group: In relation to the control group in the study, in order to provide a basis for comparing the effect of aromatherapy on the intervention and control groups, this group is deprived of routine treatment, but in order to perform the study in equal conditions to assess anxiety, first interview with children. The face image scale (FIS) tool will be done. The FIS scale consists of a row of five figures arranged from very happy to very dissatisfied. Children are asked to indicate which face best describes their feelings at that moment. This scale is scored by giving the value of one to the most positive face and five to the most negative face. In the next step, in order to increase the confidence and also to reduce the percentage of errors in execution and the results of the study, the child's cortisol level (measured with a commercial kit), heart rate and blood pressure will be measured by the doctor before and after the intervention. Anxiety rate. Timepoint: 30 minutes after the start of the intervention. Method of measurement: using FIS scale, heart rate, pulse and blood pressure, cortisol ELISA diagnostic kit. Kermanshah University of Medical Sciences Approved 2022-02-08 Ethics committee of Kermanshah University of Medical Sciences Ethics committee of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd Kermanshah Kermanshah Iran (Islamic Republic of)