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IRCT20191005044989N1 IRCT 2019-11-28 Mazandaran University of Medical Sciences The effect of Citrus aurantium extract and Diazepam on preoperative anxiety and blood glucose of ophthalmic surgery patients Comparison of the effect of Citrus aurantium extract and Diazepam on preoperative anxiety and blood glucose in patients candidate for ophthalmic surgery 2019-10-23 anticipated 105 Complete https://irct.ir/trial/42848 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To allocate groups through randomized allocation, patients were divided into 3 groups. Each group included 35 individuals. Then to equalize groups by using Block balanced randomization and the letters A and B, patients were divided into groups. And for the Allocation concealment, the sequentially numbered, sealed, opaque envelopes was used, Blinding description: The researcher who collects data leaves the room during intervention (allocation and use of medication by patient) and is completely unaware of the type of intervention. 3 Condition 1: Diseases associated with ophthalmic surgery like Cataract. Condition 2: Diseases associated with ophthalmic surgery like Strabismus. Intervention 1: First intervention group: Receiving 100 cc Citrus aurantium extract the night before surgery. In this study Citrus aurantium extract belong to Ghadah Kashan Company that has revenue operation license from agriculture association 3/1674, revenue operation license from ministry of health 12045 and sanitary making license 40/10882. Intervention 2: Second intervention group: Diazepam 5 milligram pill dissolved in 100 ml of water the night before surgery. Diazepam pill produced by Loghman Health Pharmaceutical Company with Drug Registration Number 1228034190. Intervention 3: Placebo group receiving 100 cc distilled water the night before surgery. Yes - There is a plan to make this available What will be shared: All data after unrecognizable people are Shareable When: Start of access period 8 month after publishing results To whom: Researchers working in academic and scientific institutions Conditions: Requirements for submitting a request: 1) The applicant must be affiliated with a scientific, research or academic institution. 2) The need to specify all the purposes for accessing the data. Where to obtain: Responsive people: 1) Hooshang Akbari ( assistance professor paramedic school of Mazandaran University of Medical Sciences) Email: Hooshangakbari48@yahoo.com 2) Meysam Heydari: ( MSc student of operating room paramedic school of Mazandaran University of Medical Sciences) Email: Meysam10Heidari@gmail.com How to obtain: After submitting the request, the applicant will send the request via email to the above mentioned individuals and after specifying their goals for receiving the data, the information will be sent to them up to 10 days after the request. Comments:
public Ebrahim Nasiri
No. 140 , Amir Mazandarani Ave., Keshavarzi Blvd
Sari Iran (Islamic Republic of) 6144976397 +98 11 3334 5358 rezanf2002@yahoo.com Mazandaran University of Medical Sciences scientific Hooshang Akbari
No. 140 , Amir Mazandarani Ave., Keshavarzi Blvd
Sari Iran (Islamic Republic of) 6144976397 +98 11 4348 4857 Hooshangakbari48@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients satisfaction to participate in the study All patients undergoing ophthalmic surgery requiring hospitalization the night before surgery Age between 18 and 80 years No history of diseases such as hypertension and hyperthyroidism Allergic to Citrus aurantium No diabetes history 18 years 80 years Both Patients dissatisfaction to participate in the study history of diseases such as hypertension and hyperthyroidism Any underlying diseases affecting blood sugar and anxiety of patients such as diabetes pregnant women H25.9 H50.9 Unspecified age-related cataract Unspecified strabismus Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group: Receiving 100 cc Citrus aurantium extract the night before surgery. In this study Citrus aurantium extract belong to Ghadah Kashan Company that has revenue operation license from agriculture association 3/1674, revenue operation license from ministry of health 12045 and sanitary making license 40/10882 Second intervention group: Diazepam 5 milligram pill dissolved in 100 ml of water the night before surgery. Diazepam pill produced by Loghman Health Pharmaceutical Company with Drug Registration Number 1228034190. Placebo group receiving 100 cc distilled water the night before surgery. Anxiety score. Timepoint: Before the intervention, two hours after the intervention, and one day after the intervention. Method of measurement: To evaluate patient's anxiety we will use Spielberger State_ Trait Anxiety Inventory questionnaire. The percentage of people with blood sugar above 90 mg / dL. Timepoint: Before the intervention, two hours after the intervention, and one day after the intervention. Method of measurement: To measure blood glucose level, the patient's blood sample is sent to the hospital laboratory. Mazandaran University of Medical Sciences Approved 2019-09-25 Ethics committe of Mazandaran University of Medical Sciences Research assistance, bulding number 2 of Mazandaran University of Medical Sciences, Moalem square, Sari Sari Mazandaran Iran (Islamic Republic of)