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IRCT20180623040212N1 IRCT 2019-07-21 Semnan University of Medical Sciences Effect of thyme Spray on oropharyngeal bacterial colonization Effect of thyme spray on oropharyngeal bacterial colonization in patients hospitalized in critical care units 2018-07-23 anticipated 90 Complete https://irct.ir/trial/32146 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Samples will be randomly allocated in three groups: A- thyme spray with routine care, B- routine care plus water spray and C-routine care by using a web-based software for generating random numbers (Kitset, available from: https://kitset.ir/numbers/random). According to this method, each block will contain three randomly generated numbers 1 to 3 representing the aforementioned interventions A to C respectively. The allocation of patients to the groups will follow the sequence of the randomly generated numbers in each block, Blinding description: Once each intervention is completed, the samples of the pharynx will be taken for culture; so that to prevent of any bias, a nurse who is responsible for gathering the samples of throat secretions, as well as the laboratory expert who tests the samples, and also the statistician who is responsible for analyzing data will be blinded. 3 Oropharyngeal bacterial colonization. Intervention 1: The first intervention group, in addition to routine oral care, which consists of 0.2% chlorhexidine mouth washing, manufactured by Behsa Pharmaceutical Company (Iran), three times a day, while in semi-sitting position with 45 ° angle received Thyme spray produced by Zardband Company every 6 hours for 48 hours, two puffs in the right buccal portion and two puff at the left. Intervention 2: Placebo group in addition to routine oral care, which consists of 0.2% chlorhexidine mouth washing, manufactured by Behsa Pharmaceutical Company (Iran), three times a day, will receive distilled water spray manufactured by the Samen Mashad Company (Iran) in a similar container of Thyme spray every 6 hours for 48 hours, two puffs in the right buccal and 2 puffs in the left buccal area in semi-sitting position with a 45-degree bed angle. Intervention 3: Control group receive only routine mouth care which consists of 0.2% chlorhexidine mouth washing, manufactured by Behsa Pharmaceutical Company (Iran), three times a day. 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 After publishing of final report, it will be decided.
public Mohsen Soleimani
Semnan University of Medical Sciences, 5 kilometer to Damghan road, Standard Sq., Semnan/Iran
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 soli257@yahoo.com Semnan University of Medical Sciences scientific Dr. Hesamedin Askari Majdabadi
Semnan University of Medical Sciences, 5 kilometer to Damghan road, Standard Sq., Semnan/Iran
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 hesamaskari@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Hospitalization time is less than 24 hours. Patients' age between 15 to 75 years. The patient's level of consciousness is between 3-15 according to Glasgow's coma scale. The patient feed via nasogastric tube. 15 years 75 years Both Immunodeficiency due to chemotherapy, radiotherapy and immunosuppressive diseases. Confirmed hypersensitivity to thyme compounds. J02.9 Acute pharyngitis, unspecified Prevention Placebo Other The first intervention group, in addition to routine oral care, which consists of 0.2% chlorhexidine mouth washing, manufactured by Behsa Pharmaceutical Company (Iran), three times a day, while in semi-sitting position with 45 ° angle received Thyme spray produced by Zardband Company every 6 hours for 48 hours, two puffs in the right buccal portion and two puff at the left. Placebo group in addition to routine oral care, which consists of 0.2% chlorhexidine mouth washing, manufactured by Behsa Pharmaceutical Company (Iran), three times a day, will receive distilled water spray manufactured by the Samen Mashad Company (Iran) in a similar container of Thyme spray every 6 hours for 48 hours, two puffs in the right buccal and 2 puffs in the left buccal area in semi-sitting position with a 45-degree bed angle. Control group receive only routine mouth care which consists of 0.2% chlorhexidine mouth washing, manufactured by Behsa Pharmaceutical Company (Iran), three times a day. Oropharyngeal Bacterial colonization. Timepoint: Admission time at critical care unit (before intervention) and 48 hours later. Method of measurement: Evaluation of the number of bacterial colonies in the pharynx culture sample. Beck Oral Assessment. Timepoint: Admission time at critical care unit (before intervention) and 48 hours later. Method of measurement: Beck Oral Assessment Scale. Semnan University of Medical Sciences Approved 2018-05-20 Research Ethics Committee of Semnan University of Medical Sciences and Health Semnan University of Medical Sciences, Basidj boulevard Semnan Semnan Iran (Islamic Republic of)