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IRCT20230104057049N1 IRCT 2023-01-18 Bandare-abbas University of Medical Sciences Comparing the effects of aromatherapy with rosemary essential oil and lavender essential oil on the anxiety of type 2 diabetic patients with recent diagnosis Comparing the effects of aromatherapy with rosemary essential oil and lavender essential oil on the anxiety of type 2 diabetic patients with recent diagnosis 2023-01-08 anticipated 45 Complete https://irct.ir/trial/67920 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Other design features: Non-probability sampling was done based on the entry and exit criteria of the study, then they were randomly assigned into 3 groups: aromatherapy with rosemary essential oil, aromatherapy with lavender essential oil, and control. After receiving the code of ethics and consent form. First, the patients are asked to complete the demographic information questionnaire, which includes: age, sex, marital status, occupation, history of anxiety disorder and type of diabetes, as well as the Spielberger anxiety questionnaire, as well as the working methods for the intervention groups in each session. It is explained. Therefore, people in the group of rosemary essential oil inhalation will get even numbers and people in the lavender inhalation group will get odd numbers, Randomization description: The available non-random sampling method is used to select the sample people. In this way, diabetic patients who visit the Hormoz Clinic of Shahid Mohammadi Bandar Abbas Hospital in the period of October 1401, taking into account the criteria for entering the study and completing the patient consent form by the patient or his companion according to the random block method, taking into account Taking the 6 blocks whose extracted codes are given in Table 1, the sample subjects with the same volume are assigned to one of the groups of "mohammady inhalation", "lavender inhalation" and "control group". Table (1): Random sequence generated with 6 blocks in Maine Randomization software, Blinding description: This study will be one-sided blind. In this study, in order to prevent the creation of distortion caused by the intervention of aroma therapy in the test and control group and for the purpose of research, the statistician who performs the data analysis is blinded. N/A Anxiety in diabetic patients. Intervention 1: This study is cross-sectional in three groups, where each group is conducted in two stages as an intervention and one stage as a control group. The intervention in the first group is as follows: First stage: Inhalation therapy with 10% rosemary essential oil. two drops on the pad) is done at a distance of 20 cm from the patient's nose for 20 minutes and before and immediately after the end of the post test. (wash out period) and then the second stage is performed for the first group. The second stage: therapeutic inhalation with 10% lavender essential oil (two drops on a pad) is performed at a distance of 20 cm from the patient's nose for 20 minutes. And before and immediately after the end of the intervention, the post test is done. After the second stage, in order to clean the effect of the second intervention, we have a one-week wash out period, and then the third stage is done for the first group. The third stage: At this stage, the first group becomes the control group. Inhalation therapy with odorless oil (two drops on a pad) is performed at a distance of 20 cm from the patient's nose for 20 minutes. After the completion of the intervention, the post test is done. Intervention 2: The intervention in the second group is as follows: First stage: therapeutic inhalation with 10% lavender essential oil (two drops on a pad) at a distance of 20 cm from the patient's nose for 20 minutes and before and immediately after the end of the post-test intervention After the first stage, in order to clean the effect of the first intervention, we have a wash out period, and then the second stage is done for the second group. Second stage: In this stage, the first group is controlled. come Inhalation therapy with odorless oil (two drops on the pad) is performed at a distance of 20 cm from the patient's nose for 20 minutes, and before and immediately after the end of the post-test intervention. After the second stage, in order to clean The effect of the second intervention is a one-week wash out period, and then the third stage is performed for the second group. The patient's nose is done for 20 minutes and the post-test is done before and immediately after the end of the intervention. Intervention 3: Intervention group: The intervention in the third group is as follows: First stage: In this stage, the third group becomes the control. Therapeutic inhalation with odorless oil (two drops on the pad) is performed at a distance of 20 cm from the patient's nose for 20 minutes. and before and immediately after the end of the intervention, the post test is done. After the first stage, in order to clean the effect of the first intervention, we have a wash out period, and then the second stage is done for the third group. The second stage : Inhalation therapy with 10% rosemary essential oil (two drops on a pad) is performed at a distance of 20 cm from the patient's nose for 20 minutes, and a post-test is performed before and immediately after the end of the intervention. After the second stage In order to clean the effect of the second intervention, we have a wash out period of one week, and then the third stage is performed for the third group. A meter is taken from the patient's nose for 20 minutes and a post-test is performed before and immediately after the end of the intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to confidentiality and keeping secrets
public Mohammad Hossein Taklif
Bandar Abbas, Shahid Chamran Boulevard, Hormozgan University of Medical Sciences and Health Services
Bandar Abbas Iran (Islamic Republic of) 1388579166 +98 76 3333 3280 info@hums.ac.ir Bandare-abbas University of Medical Sciences scientific Mohammad Hossin Taklif
Bandar Abbas, Shahid Chamran Boulevard, Hormozgan University of Medical Sciences and Health Services
Bandafr Abbas Iran (Islamic Republic of) 1388579166 +98 76 3333 3280 info@hums.ac.ir Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Having a medical record with confirmed diabetes Diagnosing the patient's diabetes in the last three months Having moderate to severe anxiety The patient is in the age range of 18 to 65 years Having the physical and mental ability to answer questions Aware of time, place and person 18 years 65 years Both Allergy to scented plants The patient suffers from mental and nervous problems Having a history of allergies and respiratory disease Impaired alertness, olfactory disturbances, dissatisfaction after inhalation Hemodynamic instability during intervention (such as symptoms of anaphylactic shock, severe fluctuations in blood pressure, blood sugar, and any severe disorder and the need for immediate intervention in vital signs) Decreased level of consciousness during intervention Participant's unwillingness to continue participating in the study and death Having chronic diabetic complications such as kidney failure, heart failure, visual impairment and neuropathy F15.280 Other stimulant dependence with stimulant-induced anxiety disorder Rehabilitation Rehabilitation Rehabilitation This study is cross-sectional in three groups, where each group is conducted in two stages as an intervention and one stage as a control group. The intervention in the first group is as follows: First stage: Inhalation therapy with 10% rosemary essential oil. two drops on the pad) is done at a distance of 20 cm from the patient's nose for 20 minutes and before and immediately after the end of the post test. (wash out period) and then the second stage is performed for the first group. The second stage: therapeutic inhalation with 10% lavender essential oil (two drops on a pad) is performed at a distance of 20 cm from the patient's nose for 20 minutes. And before and immediately after the end of the intervention, the post test is done. After the second stage, in order to clean the effect of the second intervention, we have a one-week wash out period, and then the third stage is done for the first group. The third stage: At this stage, the first group becomes the control group. Inhalation therapy with odorless oil (two drops on a pad) is performed at a distance of 20 cm from the patient's nose for 20 minutes. After the completion of the intervention, the post test is done. The intervention in the second group is as follows: First stage: therapeutic inhalation with 10% lavender essential oil (two drops on a pad) at a distance of 20 cm from the patient's nose for 20 minutes and before and immediately after the end of the post-test intervention After the first stage, in order to clean the effect of the first intervention, we have a wash out period, and then the second stage is done for the second group. Second stage: In this stage, the first group is controlled. come Inhalation therapy with odorless oil (two drops on the pad) is performed at a distance of 20 cm from the patient's nose for 20 minutes, and before and immediately after the end of the post-test intervention. After the second stage, in order to clean The effect of the second intervention is a one-week wash out period, and then the third stage is performed for the second group. The patient's nose is done for 20 minutes and the post-test is done before and immediately after the end of the intervention Intervention group: The intervention in the third group is as follows: First stage: In this stage, the third group becomes the control. Therapeutic inhalation with odorless oil (two drops on the pad) is performed at a distance of 20 cm from the patient's nose for 20 minutes. and before and immediately after the end of the intervention, the post test is done. After the first stage, in order to clean the effect of the first intervention, we have a wash out period, and then the second stage is done for the third group. The second stage : Inhalation therapy with 10% rosemary essential oil (two drops on a pad) is performed at a distance of 20 cm from the patient's nose for 20 minutes, and a post-test is performed before and immediately after the end of the intervention. After the second stage In order to clean the effect of the second intervention, we have a wash out period of one week, and then the third stage is performed for the third group. A meter is taken from the patient's nose for 20 minutes and a post-test is performed before and immediately after the end of the intervention. Overt and hidden anxiety scores according to Spielberger's standard questionnaire. Timepoint: After filling in the demographic questionnaire and before the aromatherapy as a pre-test and at the end of 20 minutes of aromatherapy as a post-test, anxiety is measured by the Spielberger questionnaire. Method of measurement: Spielberger questionnaire. Bandare-abbas University of Medical Sciences Approved 2022-12-04 Research Ethics Committee of Hormozgan University of Medical Sciences End of Imam Hossein Boulevard - Hormozgan University of Medical Sciences Bandar Abbas Hormozgan Iran (Islamic Republic of)