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IRCT20220516054869N4 IRCT 2023-01-19 Zahedan University of Medical Sciences The effect of midazolam on the improvement of hysteria symptoms Comparison of the effect of midazolam drug with placebo in improving the symptoms of hysterical patients referred to the emergency department 2022-12-22 anticipated 80 Complete https://irct.ir/trial/67214 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization sequence based on variable block size will be obtained from the "Random allocation". To hide the random allocation, coded envelopes are used based on the created random sequence. Inside the envelopes are drugs and placebos based on a random sequence. The envelopes have the same shape, same weight, one They are color. The only codes on the envelopes will indicate the contents of the medicine or placebo, Blinding description: For triple blinding, drug and placebo are in pre-prepared single-shaped syringes in numbered envelopes. After opening the envelope and assigning the syringe to the patients, the envelope code is written in the patient evaluation form. The patient, the outcome assessor and the data analyst do not know about the contents and codes of the envelopes. 3 Hysterical patients. Intervention 1: Intervention group: EXIR pharmaceutical company's midazolam ampoule is 2 mg in a volume of 2 cc, which will be infused intravenously for 2 minutes. Intervention 2: Control group: 2 cc of distilled water will be infused intravenously for 2 minutes. Yes - There is a plan to make this available What will be shared: All data of this research can be shared after de-identification. When: Access will start one year after the results are published. To whom: Only researchers working in academic and scientific institutions will be allowed to access the data. Conditions: Any statistical analysis will be possible for academic researchers to find out the relationship between the variables Where to obtain: Requests should be sent in writing to the responsible author's email. How to obtain: The claimant sends her /his written request and a valid ID card and employment certificate in a scientific or university institution to the responsible author via email and after the necessary checks, she /he will receive a response to her request within 2 weeks. Comments:
public Ali Abdolrazaghnejad
Daneshgah Blvd
Zahedan Iran (Islamic Republic of) 9815733169 +98 54 3323 2890 ali.abdorazzagh@gamil.com Zahedan University of Medical Sciences scientific Ali Abdolrazaghnejad
Daneshgah Blvd
Zahedan Iran (Islamic Republic of) 9815733169 +98 54 3323 2890 ali.abdorazzagh@gamil.com Zahedan University of Medical Sciences Iran (Islamic Republic of) All confirmed hysterical patients by emergency medicine specialists in the emergency room Informed consent of the patient or her / his companion 18 years 60 years Both Age less than 18 years and more than 60 years pregnacy History of liver disease Allergy to study drugs F44 Dissociative and conversion disorders Treatment - Drugs Placebo Intervention group: EXIR pharmaceutical company's midazolam ampoule is 2 mg in a volume of 2 cc, which will be infused intravenously for 2 minutes. Control group: 2 cc of distilled water will be infused intravenously for 2 minutes. Agitation. Timepoint: 0, 30, 60 minutes. Method of measurement: The presence or absence of symptoms based on clinical diagnosis by an emergency physician. Failure to communicate with others. Timepoint: 0, 30, 60 minutes. Method of measurement: The presence or absence of symptoms based on clinical diagnosis by an emergency physician. To cry. Timepoint: 0, 30, 60 minutes. Method of measurement: The presence or absence of symptoms based on clinical diagnosis by an emergency physician. Dysphonia. Timepoint: 0, 30, 60 minutes. Method of measurement: The presence or absence of symptoms based on clinical diagnosis by an emergency physician. Weaknes. Timepoint: 60 minutes after the intervention. Method of measurement: According to the history of the patient. Drowsiness. Timepoint: 0, 30, 60 minutes. Method of measurement: The presence or absence of symptoms based on clinical diagnosis by an emergency physician. Apnea. Timepoint: 30,6o minutes. Method of measurement: The presence or absence of symptoms based on clinical diagnosis by an emergency physician. Decreased breathing rate. Timepoint: 0,30,60 minutes. Method of measurement: The presence of a normal breathing rate of less than 12 per minute by observing the movements of the chest by an emergency physician. Zahedan University of Medical Sciences Approved 2022-10-15 Research Ethics Committees of Islamic Azad University-Zahedan Branch Zahedan ,Islamic Azad University, University Street, Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)