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IRCT20180306038983N1 IRCT 2018-05-23 Mashhad University of Medical Sciences the effect Probiotic in cutaneous complications of colostomy The effect Probiotic in Local cutaneous complications In children with gastrointestinal ostoma 2016-04-12 anticipated 30 Complete https://irct.ir/trial/30600 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: -, Blinding description: -. 4 Colostomy. Intervention 1: "Intervention group":After obtaining permission from the Ethics Committee of Mashhad University of Medical Sciences and receiving a written reference from the Mashhad Nursing and Midwifery Faculty, it was submitted to the MSI in the research environment and coordination with the department responsible for the operation of the doctor's hospital and the coordination with the relevant doctors. will be. After co-ordinating with the research environment, referring to the Department of Surgery in the doctor's hospital, the infants from 6 months to 2 years of age who have been undergoing surgical procedures for any of the underlying problems that were under colostomy insertion surgery, or through the information contained in the archives file. They have already been identified and contacted at home clinostomy. In both cases, after their introduction and access to their specifications, they will be given a brief explanation of the goals and manner of doing the research. To The control of the mediating variable of the age range is limited to the lowest difference in diet Be in research units. At the same time, given that the sst tool can accurately display changes in the patient's skin condition over time. In practice, by performing precise follow-up studies in both groups, virtually every patient is self-controlled. Because the forecast sees changes over time. At the first referral of a child, the first choice of the research unit, which includes exclusion criteria and inclusion criteria, will be selected by the researcher through an interview with the patient's mother and the measurement of the child's height and weight, and the eligible patient will be selected. Subsequently, the children eligible for the study Descriptions of the research goals will be presented by the researcher face to face for 10 to 15 minutes. If they wish to participate in the study, they will be informed by the researcher in a written informed consent form, and the individual profile will be completed in an interview and using the patient's case. In order to improve the quality of nursing care from the ulcer in two groups Traveller and intervention Nursing care program from an osteomy is trained in each of the two groups before the intervention begins, and the booksleet is provided to caregivers of the child. The care includes, how to attach and remove the ostomy bag, washing and cleaning the skin around the stoma, teaching a variety of complications Stoma, bathing, swimming, dressing up, sleeping, activities, traveling, walking. The investigator will provide his telephone number to answer questions. Immediately after training, the intervention begins, and is done daily or I contacted the research unit every 3 days to ensure that the care plan is followed To be For this purpose, a checklist is designed that receiving a score of over 75% of the checklist means strict adherence to the program. People who do not receive 75% of the total score are re-educated. This process will be performed in 3 rounds, with up to 3 training sessions, 75% of the score will not be excluded from the research. The evaluation of the full checklist is only done by the researcher. In the case of home-based research units, assessments and reviews can be made by taking pictures by parents and sending them through telegrams or face-to-face visits. To assist in finding research units, a researcher who is responsible for the operating room of Dr. Sheikh Hospital and a graduate student of nursing specialist neonates is introduced due to his constant contact with these patients as a researcher's assistance. Subsequently, the intervention group for one On a weekly basis, one probiotic capsule dissolved in 20cc of yogurt is given. Before the onset of the intervention, on the fourth day of probiotic consumption and the end of a week, a probiotic, a stool analysis, and a Ostomy Skin Tool will be done. The instrument will examine the condition of the skin surrounding the stoma in terms of the extent of the inflammatory position, the excess tissue, and the color change. One week after the intervention: again, all research units will be tested on the stool analysis and the Ostomy Skin Tool. Considering that the parents of the patient And the statistical analyzer did not know how to group the research units into two groups, so a double-blind study would be. Intervention 2: "Control group": After obtaining permission from the Ethics Committee of Mashhad University of Medical Sciences and receiving a written reference from the Mashhad Nursing and Midwifery Faculty, it was submitted to the Medical Research Center and coordinated with the Department of Surgery of Dr Shaikh Hospital and coordination with the relevant physicians. will be. After co-ordinating with the research environment, referring to the Department of Surgery in the doctor's hospital, the infants from 6 months to 2 years of age who have been undergoing surgical procedures for any of the underlying problems that were under colostomy insertion surgery, or through the information contained in the archives file. They have already been identified and contacted at home clinostomy. In both cases, after their introduction and access to their specifications, they will be given a brief explanation of the goals and manner of doing the research. To The control of the mediating variable of the age range is limited to the lowest difference in diet Be in research units. At the same time, given that the sst tool can accurately display changes in the patient's skin condition over time. In practice, by performing precise follow-up studies in both groups, virtually every patient is self-controlled. Because the forecast sees changes over time. At the first referral of a child, the first choice of the research unit, which includes exclusion criteria and inclusion criteria, will be selected by the researcher through an interview with the patient's mother and the measurement of the child's height and weight, and the eligible patient will be selected. Subsequently, the children eligible for the study Descriptions of the research goals will be presented by the researcher face to face for 10 to 15 minutes. If they wish to participate in the study, they will be informed by the researcher in a written informed consent form, and the individual profile will be completed in an interview and using the patient's case. In order to improve the quality of nursing care from the ulcer in two groups Traveller and intervention Nursing care program from an osteomy is trained in each of the two groups before the intervention begins, and the booksleet is provided to caregivers of the child. The care includes, how to attach and remove the ostomy bag, washing and cleaning the skin around the stoma, teaching a variety of complications Stoma, bathing, swimming, dressing up, sleeping, activities, traveling, walking. The investigator will provide his telephone number to answer questions. Immediately after training, the intervention begins, and is done daily or I contacted the research unit every 3 days to ensure that the care plan is followed To be For this purpose, a checklist is designed that receiving a score of over 75% of the checklist means strict adherence to the program. People who do not receive 75% of the total score are re-educated. This process will be performed in 3 rounds, with up to 3 training sessions, 75% of the score will not be excluded from the research. The evaluation of the full checklist is only done by the researcher. In the case of home-based research units, assessments and reviews can be made by taking pictures by parents and sending them through telegrams or face-to-face visits. To assist in finding research units, a researcher who is in charge of the operating room of Dr. Sheikh Hospital and a graduate student of nursing specialist neonates is introduced due to his constant contact with these patients as a researcher's assistance. Continuing the control group for one Each week, one capsule of placebo is dissolved in 20 cc of yogurt (yasir). The placenta is starchy and looks like a probiotic capsule. Before the onset of the intervention, on the 4th day of the placebo and the end of one week, the placebo was taken, the analytical test Stool and Ostomy Skin Tool. The instrument will examine the status of the skin around the stoma in terms of the extent of the inflamed position, the extra tissue, and the color change. One week after the intervention, all research units will be tested on the stool analysis and the Ostomy Skin Tool. Given that the parents are sick and The statistical analyzer did not know how to group the research units into two groups, so a double-blind study would be. 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 No more information
public Mahboobeh Ghasemirad
Unit B3, Bahar Building, Razi Street 9, Razi Blvd
Sabzevar Iran (Islamic Republic of) 9618611111 +98 51 4466 8361 Ghasemiradm931@mums.ac.ir Mashhad University of Medical Sciences scientific Mahboobeh Ghasemirad
Unit B3, Bahar Building, Razi Street 9, Razi Blvd
Sabzevar Iran (Islamic Republic of) 9618611111 +98 51 4466 8361 Ghasemiradm931@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) pediatric with colostomy 6 months 2 years Both K55-K64 Other Diseases Of Intestines Prevention Placebo "Intervention group":After obtaining permission from the Ethics Committee of Mashhad University of Medical Sciences and receiving a written reference from the Mashhad Nursing and Midwifery Faculty, it was submitted to the MSI in the research environment and coordination with the department responsible for the operation of the doctor's hospital and the coordination with the relevant doctors. will be. After co-ordinating with the research environment, referring to the Department of Surgery in the doctor's hospital, the infants from 6 months to 2 years of age who have been undergoing surgical procedures for any of the underlying problems that were under colostomy insertion surgery, or through the information contained in the archives file. They have already been identified and contacted at home clinostomy. In both cases, after their introduction and access to their specifications, they will be given a brief explanation of the goals and manner of doing the research. To The control of the mediating variable of the age range is limited to the lowest difference in diet Be in research units. At the same time, given that the sst tool can accurately display changes in the patient's skin condition over time. In practice, by performing precise follow-up studies in both groups, virtually every patient is self-controlled. Because the forecast sees changes over time. At the first referral of a child, the first choice of the research unit, which includes exclusion criteria and inclusion criteria, will be selected by the researcher through an interview with the patient's mother and the measurement of the child's height and weight, and the eligible patient will be selected. Subsequently, the children eligible for the study Descriptions of the research goals will be presented by the researcher face to face for 10 to 15 minutes. If they wish to participate in the study, they will be informed by the researcher in a written informed consent form, and the individual profile will be completed in an interview and using the patient's case. In order to improve the quality of nursing care from the ulcer in two groups Traveller and intervention Nursing care program from an osteomy is trained in each of the two groups before the intervention begins, and the booksleet is provided to caregivers of the child. The care includes, how to attach and remove the ostomy bag, washing and cleaning the skin around the stoma, teaching a variety of complications Stoma, bathing, swimming, dressing up, sleeping, activities, traveling, walking. The investigator will provide his telephone number to answer questions. Immediately after training, the intervention begins, and is done daily or I contacted the research unit every 3 days to ensure that the care plan is followed To be For this purpose, a checklist is designed that receiving a score of over 75% of the checklist means strict adherence to the program. People who do not receive 75% of the total score are re-educated. This process will be performed in 3 rounds, with up to 3 training sessions, 75% of the score will not be excluded from the research. The evaluation of the full checklist is only done by the researcher. In the case of home-based research units, assessments and reviews can be made by taking pictures by parents and sending them through telegrams or face-to-face visits. To assist in finding research units, a researcher who is responsible for the operating room of Dr. Sheikh Hospital and a graduate student of nursing specialist neonates is introduced due to his constant contact with these patients as a researcher's assistance. Subsequently, the intervention group for one On a weekly basis, one probiotic capsule dissolved in 20cc of yogurt is given. Before the onset of the intervention, on the fourth day of probiotic consumption and the end of a week, a probiotic, a stool analysis, and a Ostomy Skin Tool will be done. The instrument will examine the condition of the skin surrounding the stoma in terms of the extent of the inflammatory position, the excess tissue, and the color change. One week after the intervention: again, all research units will be tested on the stool analysis and the Ostomy Skin Tool. Considering that the parents of the patient And the statistical analyzer did not know how to group the research units into two groups, so a double-blind study would be. "Control group": After obtaining permission from the Ethics Committee of Mashhad University of Medical Sciences and receiving a written reference from the Mashhad Nursing and Midwifery Faculty, it was submitted to the Medical Research Center and coordinated with the Department of Surgery of Dr Shaikh Hospital and coordination with the relevant physicians. will be. After co-ordinating with the research environment, referring to the Department of Surgery in the doctor's hospital, the infants from 6 months to 2 years of age who have been undergoing surgical procedures for any of the underlying problems that were under colostomy insertion surgery, or through the information contained in the archives file. They have already been identified and contacted at home clinostomy. In both cases, after their introduction and access to their specifications, they will be given a brief explanation of the goals and manner of doing the research. To The control of the mediating variable of the age range is limited to the lowest difference in diet Be in research units. At the same time, given that the sst tool can accurately display changes in the patient's skin condition over time. In practice, by performing precise follow-up studies in both groups, virtually every patient is self-controlled. Because the forecast sees changes over time. At the first referral of a child, the first choice of the research unit, which includes exclusion criteria and inclusion criteria, will be selected by the researcher through an interview with the patient's mother and the measurement of the child's height and weight, and the eligible patient will be selected. Subsequently, the children eligible for the study Descriptions of the research goals will be presented by the researcher face to face for 10 to 15 minutes. If they wish to participate in the study, they will be informed by the researcher in a written informed consent form, and the individual profile will be completed in an interview and using the patient's case. In order to improve the quality of nursing care from the ulcer in two groups Traveller and intervention Nursing care program from an osteomy is trained in each of the two groups before the intervention begins, and the booksleet is provided to caregivers of the child. The care includes, how to attach and remove the ostomy bag, washing and cleaning the skin around the stoma, teaching a variety of complications Stoma, bathing, swimming, dressing up, sleeping, activities, traveling, walking. The investigator will provide his telephone number to answer questions. Immediately after training, the intervention begins, and is done daily or I contacted the research unit every 3 days to ensure that the care plan is followed To be For this purpose, a checklist is designed that receiving a score of over 75% of the checklist means strict adherence to the program. People who do not receive 75% of the total score are re-educated. This process will be performed in 3 rounds, with up to 3 training sessions, 75% of the score will not be excluded from the research. The evaluation of the full checklist is only done by the researcher. In the case of home-based research units, assessments and reviews can be made by taking pictures by parents and sending them through telegrams or face-to-face visits. To assist in finding research units, a researcher who is in charge of the operating room of Dr. Sheikh Hospital and a graduate student of nursing specialist neonates is introduced due to his constant contact with these patients as a researcher's assistance. Continuing the control group for one Each week, one capsule of placebo is dissolved in 20 cc of yogurt (yasir). The placenta is starchy and looks like a probiotic capsule. Before the onset of the intervention, on the 4th day of the placebo and the end of one week, the placebo was taken, the analytical test Stool and Ostomy Skin Tool. The instrument will examine the status of the skin around the stoma in terms of the extent of the inflamed position, the extra tissue, and the color change. One week after the intervention, all research units will be tested on the stool analysis and the Ostomy Skin Tool. Given that the parents are sick and The statistical analyzer did not know how to group the research units into two groups, so a double-blind study would be. Checker tool score the skin around the colostomy. Timepoint: . Before the intervention, the fourth day of intervention, after the end of the care period and one week after the probiotic has stopped, the Ostomy Skin Tool will be checked. Method of measurement: a tool for checking skin around colostomy(SST). Stool acidity. Timepoint: Before the intervention, the fourth day of intervention, after the end of the care period and one week after the interruption of the probiotic, a fecal analysis test will be performed. Method of measurement: Stool analysis test. Skin color around colostomy. Timepoint: Before the intervention, the fourth day of intervention, after the completion of the care period and one week after the interruption of the probiotic. Method of measurement: See researcher. Stool color. Timepoint: Before the intervention, the fourth day of intervention, after the completion of the care period and one week after the interruption of the probiotic. Method of measurement: See researcher. Consistency of stool. Timepoint: Before the intervention, the fourth day of intervention, after the completion of the care period and one week after the interruption of the probiotic. Method of measurement: See researcher. Mashhad University of Medical Sciences Approved 2016-05-25 The Ethics Committee of Mashhad University of Medical Sciences Ebnesina Ave, Doctora Four-way, University Ave, Mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)