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IRCT20110906007494N47 IRCT 2025-05-14 Mazandaran University of Medical Sciences Effect of Benson's sedation on nitroglycerin-induced headache The effect of Benson's relaxation on range of headache-induced by intravenous infusion of nitroglycerin in acute coronary syndrome patients 2025-03-25 anticipated 60 Complete https://irct.ir/trial/80395 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling is done in an accessible manner. And based on statistical software, permuted block randomization method, random allocation is done in each group and 15 blocks of 4 are designed. So that 2 cards A and 2 cards B are placed in each block. 60 envelopes with lids with numbers 1-60 are inserted. A and B cards are placed inside the envelopes based on the numbers of the software, and based on the date of admission of the patients to the department, the envelopes are opened in order of number and the patients enter the study. N/A Acute Coronary Syndrome. Intervention 1: Intervention group: For the intervention group, the sedation method will be performed by the researcher on the bed in Fatemeh Zahra Hospital in Sari. This intervention will be performed for 15 minutes in the presence and with the help of a nurse after 5 minutes of teaching the patient how to take deep breaths. (After 15 minutes of starting the nitroglycerin infusion, 5 minutes of deep breathing training will be given, in other words, the intervention will be performed 20 minutes after starting the intravenous nitroglycerin infusion.) Intravenous nitroglycerin infusion will be performed at a dose of 5 micrograms per minute and a rate of 6 drops per minute (27); so that the intervention group will receive sedation despite the standard treatment (injection of one gram of intravenous acetaminophen or Apotel) (9). Intervention 2: Control group: The control group will receive the same dose of 5 micrograms per minute intravenous nitroglycerin infusion and, in the event of headache, the same protocol for treating headache caused by intravenous nitroglycerin infusion, which is an intravenous injection of 1 gram of acetaminophen, will be used (9); however, they will not receive any sedative intervention. Headache measurements in the control group will be performed similarly to those in the intervention group at 15, 35, and 60 minutes after the start of the intravenous nitroglycerin infusion. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr.Masoumeh Bagheri Nesami
Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sar
Sari Iran (Islamic Republic of) 4816715793 +98 11 3379 5508 anna3043@gmail.com Mazandaran University of Medical Sciences scientific Masoumeh Bagheri Nesami
Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sari
Sari Iran (Islamic Republic of) 4816715793 +98 11 3379 5508 ann3043@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) A new diagnosis of ACS Age above 18 years No migraine headaches and any other headaches No drug addiction Absence of neurological disorders under drug treatment Absence of headache before starting nitroglycerin injection Absence of pain in other parts of the body (except chest pain) Absence of speech and vision disorders Not using oral and topical nitrate drugs 18 years 65 years Both Lack of ability due to increased chest pain and confusion of the patient's hemodynamic symptoms (sbp<100, p<60) The need to increase the dose of nitroglycerin received (more than 5 micrograms per minute) Lack of cooperation with the researcher I24.0 Acute coronary thrombosis not resulting in myocardial infarction Treatment - Other Treatment - Other Intervention group: For the intervention group, the sedation method will be performed by the researcher on the bed in Fatemeh Zahra Hospital in Sari. This intervention will be performed for 15 minutes in the presence and with the help of a nurse after 5 minutes of teaching the patient how to take deep breaths. (After 15 minutes of starting the nitroglycerin infusion, 5 minutes of deep breathing training will be given, in other words, the intervention will be performed 20 minutes after starting the intravenous nitroglycerin infusion.) Intravenous nitroglycerin infusion will be performed at a dose of 5 micrograms per minute and a rate of 6 drops per minute (27); so that the intervention group will receive sedation despite the standard treatment (injection of one gram of intravenous acetaminophen or Apotel) (9). Control group: The control group will receive the same dose of 5 micrograms per minute intravenous nitroglycerin infusion and, in the event of headache, the same protocol for treating headache caused by intravenous nitroglycerin infusion, which is an intravenous injection of 1 gram of acetaminophen, will be used (9); however, they will not receive any sedative intervention. Headache measurements in the control group will be performed similarly to those in the intervention group at 15, 35, and 60 minutes after the start of the intravenous nitroglycerin infusion. Pain. Timepoint: For both the intervention and control groups, The first headache measurement will be done 15 minutes after the start of intravenous nitroglycerin infusion (before the intervention). The second measurement of headache will be done 35 minutes after the start of intravenous nitroglycerin infusion (immediately after the end of sedation) and the third measurement of headache will be done 60 minutes after the start of intravenous nitroglycerin infusion (after the intervention). Method of measurement: Visual Analogue Scale. Mazandaran Mideacal Science Approved 2025-01-01 Ethics Committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square. , Sari, Mazandaran, Iran. Sari Mazandaran Iran (Islamic Republic of)