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IRCT20220328054364N1 IRCT 2022-06-21 Esfahan University of Medical Sciences Evaluation of the effectiveness of Chlorhexidine and sodium bicarbonate mouthwash solutions on the onset of Covid-19 symptoms Comparative study of the effect of two solutions of Chlorhexidine and sodium bicarbonate mouthwash on the onset of Covid-19 related symptoms in vaccinated operating room staff 2022-07-06 anticipated 120 Complete https://irct.ir/trial/64210 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this research, the researcher first enters the study of the operating room personnel by calling in the research environment and explaining the title, taking into account the inclusion criteria, by easy sampling method. In order to balance the number of samples assigned to each of the study groups, the block randomization method will be used and the size of each block will be considered 3. For random allocation with random blocks, a valid website (https://www.sealedenvelope.com/simple-randomiser/v1/lists) will be used, then the samples will be placed in each of the intervention or control groups, Blinding description: In order to blind the study and not inform the staff about the type of mouthwash, the type of solution is not written on the bottles and the type of solution will be determined using coding. Also the bottles are made similar and opaque, and the food coloring is used to match the color of the solutions.In addition, the person analyzing the data will not know the details of the groupings. N/A Covid-19. Intervention 1: In intervention group 1, after preparing dark colored medicine glass bottles that are uniform, the researcher prepares 0.2% Chlorhexidine solution under the brand name Vi-one in the form of mouthwash solutions prepared from the pharmacy and only the bottle is changed. The mouthwash solution is used once in the morning and once in the evening in the amount of 15 ml for one minute. Before using mouthwash, you must use a toothbrush and eat and drink is forbidden for at least half an hour after using mouthwash. Due to the fact that some toothpastes may have antimicrobial properties, in this study, the researcher prepared plain mint toothpaste from Goltash Company and provided samples to all three groups. This toothpaste is simple and without properties. It is antimicrobial. The duration of mouthwash is two weeks, then mouthwash is stopped and personnel are followed for four weeks from the first day of mouthwash to check the onset of symptoms of Quid-19. Personnel are checked. During the four weeks that the staff is monitored, they must record and report their symptoms once a week in the symptom checklist, and if they observe any suspicious signs other than one week apart, they must Make a note of the checklist mentioned. At one-week intervals, a total of four staff members record their symptoms in a symptom checklist four times over a four-week period. The research units are asked to inform the researcher when any of the signs that have already been explained to them appear. The researcher records each of the signs that appear along with the personnel details. PCR testing will be performed on staff if required. By creating a group in WhatsApp software and daily consumption table of mouthwash, the use of mouthwash is reminded and recorded. How to use mouthwash and its important points are written on the bottles and in addition it is explained orally. Intervention 2: In intervention group 2, the researcher prepares dark colored medicine glass bottles that are uniform. Sodium bicarbonate solution is prepared by the researcher as a mouthwash solution of 5.7% (per 100 ml of water containing 5.7 grams of sodium bicarbonate) using an accurate scale with Imperial brand and graduated glasses and after dissolving it , Is poured into glass bottles. The mouthwash solution is used once in the morning and once in the evening in the amount of 15 ml for one minute. Before using mouthwash, you must use a toothbrush and eat and drink is forbidden for at least half an hour after using mouthwash. Due to the fact that some toothpastes may have antimicrobial properties, in this study, the researcher prepared plain mint toothpaste from Goltash Company and provided samples to all three groups. This toothpaste is simple and without properties. It is antimicrobial. The duration of mouthwash is two weeks, then mouthwash is stopped and personnel are followed for four weeks from the first day of mouthwash to check the onset of symptoms of Quid-19. Personnel are checked. During the four weeks that the staff is monitored, they must record and report their symptoms once a week in the symptom checklist, and if they observe any suspicious signs other than one week apart, they must Make a note of the checklist mentioned. At one-week intervals, a total of four staff members record their symptoms in a symptom checklist four times over a four-week period. The research units are asked to inform the researcher when any of the signs that have already been explained to them appear. The researcher records each of the signs that appear along with the personnel details. PCR testing will be performed on staff if required. By creating a group in WhatsApp software and daily consumption table of mouthwash, the use of mouthwash is reminded and recorded. How to use mouthwash and its important points are written on the bottles and in addition it is explained orally. Intervention 3: Control group: Control group: The third mouthwash of the study is a placebo. In this study, purified water is considered. Due to the use of piped drinking water in the preparation of sodium bicarbonate solution, for the placebo, purified drinking water is also piped. Used. According to the rules of placebo, in order for these three solutions to be the same shape and not to cause a problem in blinding, and according to the fact that the Chlorhexidine solution prepared is blue, the researcher added a food coloring of blue liquid which is soluble in water. It uses a small amount of the other two mouthwashes, purified water and sodium bicarbonate. The permissible oral color of the liquid is added with a dropper and in a certain volume of the mouthwash solution and compared with the Chlorhexidine solution to make them look similar in color. The mouthwash solution is used once in the morning and once in the evening in the amount of 15 ml for one minute. Before using mouthwash, you must use a toothbrush and eat and drink is forbidden for at least half an hour after using mouthwash. Due to the fact that some toothpastes may have antimicrobial properties, in this study, the researcher prepared plain mint toothpaste from Goltash Company and provided samples to all three groups. This toothpaste is simple and without properties. It is antimicrobial. The duration of mouthwash is two weeks, then mouthwash is stopped and personnel are followed for four weeks from the first day of mouthwash to check the onset of symptoms of Quid-19. Personnel are checked. During the four weeks that the staff is monitored, they must record and report their symptoms once a week in the symptom checklist, and if they observe any suspicious signs other than one week apart, they must Make a note of the checklist mentioned. At one-week intervals, a total of four staff members record their symptoms in a symptom checklist four times over a four-week period. The research units are asked to inform the researcher when any of the signs that have already been explained to them appear. The researcher records each of the signs that appear along with the personnel details. PCR testing will be performed on staff if required. By creating a group in WhatsApp software and daily consumption table of mouthwash, the use of mouthwash is reminded and recorded. How to use mouthwash and its important points are written on the bottles and in addition it is explained orally. Yes - There is a plan to make this available What will be shared: Once the individuals are unidentifiable, all data will be published, including information about the main outcome as well as contextual variables such as the age and sex of the study participants. When: Access period starts 6 months after the results are published To whom: Researchers working at academic institutions will have access to the data. Conditions: Use of data for 1. Therapeutic 2. Research purposes Where to obtain: Hanieh Karami Chamgordani haniehkarami@nm.mui.ac.ir How to obtain: Send a request by contact and provide evidence for use in research or treatment and receive data Comments:
public Hanieh Karami Chamgordani
Faculty of Nursing and Midwifery ,Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7516 haniehkarami@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Dr Akram Aarabi
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7516 aarabi@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Personnel with an age range of 18-60 years Get at least two doses of the vaccine At least two weeks have passed since the second dose of the vaccine was given 18 years 60 years Both Pregnant personnel Breastfeeding period History of allergy to mouthwash solutions Taking immunosuppressive drugs Having Covid-19 in the last two months Having symptoms of systemic infection B97.21 SARS-associated coronavirus as the cause of diseases classified elsewhere Early detection Early detection Placebo In intervention group 1, after preparing dark colored medicine glass bottles that are uniform, the researcher prepares 0.2% Chlorhexidine solution under the brand name Vi-one in the form of mouthwash solutions prepared from the pharmacy and only the bottle is changed. The mouthwash solution is used once in the morning and once in the evening in the amount of 15 ml for one minute. Before using mouthwash, you must use a toothbrush and eat and drink is forbidden for at least half an hour after using mouthwash. Due to the fact that some toothpastes may have antimicrobial properties, in this study, the researcher prepared plain mint toothpaste from Goltash Company and provided samples to all three groups. This toothpaste is simple and without properties. It is antimicrobial. The duration of mouthwash is two weeks, then mouthwash is stopped and personnel are followed for four weeks from the first day of mouthwash to check the onset of symptoms of Quid-19. Personnel are checked. During the four weeks that the staff is monitored, they must record and report their symptoms once a week in the symptom checklist, and if they observe any suspicious signs other than one week apart, they must Make a note of the checklist mentioned. At one-week intervals, a total of four staff members record their symptoms in a symptom checklist four times over a four-week period. The research units are asked to inform the researcher when any of the signs that have already been explained to them appear. The researcher records each of the signs that appear along with the personnel details. PCR testing will be performed on staff if required. By creating a group in WhatsApp software and daily consumption table of mouthwash, the use of mouthwash is reminded and recorded. How to use mouthwash and its important points are written on the bottles and in addition it is explained orally. In intervention group 2, the researcher prepares dark colored medicine glass bottles that are uniform. Sodium bicarbonate solution is prepared by the researcher as a mouthwash solution of 5.7% (per 100 ml of water containing 5.7 grams of sodium bicarbonate) using an accurate scale with Imperial brand and graduated glasses and after dissolving it , Is poured into glass bottles. The mouthwash solution is used once in the morning and once in the evening in the amount of 15 ml for one minute. Before using mouthwash, you must use a toothbrush and eat and drink is forbidden for at least half an hour after using mouthwash. Due to the fact that some toothpastes may have antimicrobial properties, in this study, the researcher prepared plain mint toothpaste from Goltash Company and provided samples to all three groups. This toothpaste is simple and without properties. It is antimicrobial. The duration of mouthwash is two weeks, then mouthwash is stopped and personnel are followed for four weeks from the first day of mouthwash to check the onset of symptoms of Quid-19. Personnel are checked. During the four weeks that the staff is monitored, they must record and report their symptoms once a week in the symptom checklist, and if they observe any suspicious signs other than one week apart, they must Make a note of the checklist mentioned. At one-week intervals, a total of four staff members record their symptoms in a symptom checklist four times over a four-week period. The research units are asked to inform the researcher when any of the signs that have already been explained to them appear. The researcher records each of the signs that appear along with the personnel details. PCR testing will be performed on staff if required. By creating a group in WhatsApp software and daily consumption table of mouthwash, the use of mouthwash is reminded and recorded. How to use mouthwash and its important points are written on the bottles and in addition it is explained orally. Control group: Control group: The third mouthwash of the study is a placebo. In this study, purified water is considered. Due to the use of piped drinking water in the preparation of sodium bicarbonate solution, for the placebo, purified drinking water is also piped. Used. According to the rules of placebo, in order for these three solutions to be the same shape and not to cause a problem in blinding, and according to the fact that the Chlorhexidine solution prepared is blue, the researcher added a food coloring of blue liquid which is soluble in water. It uses a small amount of the other two mouthwashes, purified water and sodium bicarbonate. The permissible oral color of the liquid is added with a dropper and in a certain volume of the mouthwash solution and compared with the Chlorhexidine solution to make them look similar in color. The mouthwash solution is used once in the morning and once in the evening in the amount of 15 ml for one minute. Before using mouthwash, you must use a toothbrush and eat and drink is forbidden for at least half an hour after using mouthwash. Due to the fact that some toothpastes may have antimicrobial properties, in this study, the researcher prepared plain mint toothpaste from Goltash Company and provided samples to all three groups. This toothpaste is simple and without properties. It is antimicrobial. The duration of mouthwash is two weeks, then mouthwash is stopped and personnel are followed for four weeks from the first day of mouthwash to check the onset of symptoms of Quid-19. Personnel are checked. During the four weeks that the staff is monitored, they must record and report their symptoms once a week in the symptom checklist, and if they observe any suspicious signs other than one week apart, they must Make a note of the checklist mentioned. At one-week intervals, a total of four staff members record their symptoms in a symptom checklist four times over a four-week period. The research units are asked to inform the researcher when any of the signs that have already been explained to them appear. The researcher records each of the signs that appear along with the personnel details. PCR testing will be performed on staff if required. By creating a group in WhatsApp software and daily consumption table of mouthwash, the use of mouthwash is reminded and recorded. How to use mouthwash and its important points are written on the bottles and in addition it is explained orally. Headache. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Temperatures. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Medical thermometer (Record in the checklist of symptoms). Cough. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Shortness of breath. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Muscular pain. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Sore throat. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Runny nose and nasal congestion. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Sneezing. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Lethargy. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Dizziness. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Anorexia. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Diarrhea. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Vomit. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Decreased sense of taste. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Decreased sense of smell. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Skin rash. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Red and irritated eyes. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Lacrimation. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Weakness. Timepoint: For 4 weeks, from the beginning of using mouthwash. Method of measurement: Record in the checklist of symptoms. Esfahan University of Medical Sciences Approved 2022-06-11 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)