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IRCT20200707048035N1 IRCT 2021-07-02 Shiraz University of Medical Sciences Mobile-Based dietary program education on Constipation Management and quality of life Investigating the influence of Mobile-Based dietary program education on Constipation Management and quality of life of Peritoneal dialysis patients 2021-07-11 anticipated 30 Complete https://irct.ir/trial/49731 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, we will use the block randomization method. Random sequence generation software is also used for randomization. After obtaining written consent, patients will be randomly assigned to blocks of 6 (including 3 participants in the diet + placebo group and 3 participants in the standard treatment group) at a ratio of 1: 1. For concealment, we use random allocation concealment, so that the assigned group is not known before the individual is assigned, Blinding description: C-lax and placebo tablets made by Shiraz School of Pharmacy with similar appearance will be packed in medicine boxes with a similar appearance and will be delivered with the Researcher's assistance. Patients who meet the inclusion criteria from the physician's point of view are selected for inclusion in the study with the help of the Researcher's assistance, And based on the specified random sequence, they are divided into two groups made in WhatsApp software and will receive the bottle with the symbol A or B. Patient education is performed by the principal investigator, patient assessment by the treating physician, and data collection is performed by the Researcher's assistance. All of these people, plus the person performing the statistical analysis, will be unaware of whether A or B is related to the drug or placebo until the end of the study and data analysis. Patients are treated at home and will not be unaware of the allocation of study groups due to their training, but will be unaware of whether A or B is related to medication or placebo until the end of the study. Peritoneal dialysis is performed at home and diet training in the intervention group will be individual. 3 constipation. Intervention 1: The intervention group will be held for 4 weeks by holding training sessions in absentia and through the membership of group members in groups formed in WhatsApp software via mobile. Training sessions for the case group will include 5-10 minute sessions that will take place on days 5-1. Educational content will include the definition of peritoneal dialysis, constipation, the importance of constipation and its complications in patients undergoing peritoneal dialysis, the diet of patients undergoing peritoneal dialysis (fruits, vegetables, and water), and appropriate activities to relieve constipation. Questions and answers, group discussions, and educational videos will be provided through WhatsApp software. Patients will then be reviewed and followed up for 3 weeks in terms of adherence to the educational content provided, diet consumed and how to consume the recommended items and the current situation, and appropriate feedback will be provided if needed. In addition to training, the case group will be given a placebo. The above-mentioned placebo is two corn starch tablets (after preparation by Shiraz University of Medical Sciences Pharmaceutical Company) with the brand name C-Lax‌, which patients will receive twice a day, similar to the control group. The placebo will be similar in color, shape, and weight to the C-Lax tablet made by the Dineh Iran company. Intervention 2: Standard treatment group: This group will be treated twice a day as usual with C-Lax made by Dineh Iran Company. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: Access period starts 6 months after the results are published. To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: The results of the study can be used to complete the research of academic researchers on dialysis patients and patients with constipation. Where to obtain: In order to access the results of the studies, it is possible to contact Mr. Javad Rajabzadeh (listed in the Iranian Clinical Trial Registration Center) through various communication channels. Email address: javadrajabzade888@gmail.com How to obtain: Six months after the publication of the results, the applicant can send a request for the use of data and documents through the communication channels listed in the Iranian Clinical Trial Registration, and an appropriate response will be provided to their request at least three months from the date of application. Comments:
public javad rajab zadeh
Central part, Esfikh village
Torbat-e Heydarieh Iran (Islamic Republic of) 9513176638 +98 51 5241 0300 javadrajabzade888@Gmail.com Shiraz University of Medical Sciences scientific Javad Rajab Zadeh
Esfiukh
Torbat heydaryeh Iran (Islamic Republic of) 9513176638 +98 51 5241 0300 javadrajabzade888@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients older than 18 years, treated with peritoneal dialysis in Shiraz University of Medical Sciences Peritoneal Dialysis Centers in 2021 Ability to read and write Access telecommunications facilities such as telephones or cell phones. Get a score of 1 and 2 on the Bristol chart. Informed consent to enter the study. Patients with symptoms of constipation at the time of screening (average <3 spontaneous bowel movements per week + symptoms related to constipation in at least 25% of bowel movements). 18 years no limit Both Current use of medications known to have constipation effects (such as narcotics, calcium channel blockers, tricyclic antidepressants, and anti-parasympathetic drugs), pregnancy or lactation, history of alcohol or drug abuse, and no history of thyroid disease And family; and other significant or uncontrolled illnesses (patients with one of the following conditions: dementia, colitis, irritable bowel syndrome). If the patient undergoes a kidney transplant during the intervention, or does not want to continue participating in the study, he will be excluded from the study. K59.0 Constipation Behavior Treatment - Drugs The intervention group will be held for 4 weeks by holding training sessions in absentia and through the membership of group members in groups formed in WhatsApp software via mobile. Training sessions for the case group will include 5-10 minute sessions that will take place on days 5-1. Educational content will include the definition of peritoneal dialysis, constipation, the importance of constipation and its complications in patients undergoing peritoneal dialysis, the diet of patients undergoing peritoneal dialysis (fruits, vegetables, and water), and appropriate activities to relieve constipation. Questions and answers, group discussions, and educational videos will be provided through WhatsApp software. Patients will then be reviewed and followed up for 3 weeks in terms of adherence to the educational content provided, diet consumed and how to consume the recommended items and the current situation, and appropriate feedback will be provided if needed. In addition to training, the case group will be given a placebo. The above-mentioned placebo is two corn starch tablets (after preparation by Shiraz University of Medical Sciences Pharmaceutical Company) with the brand name C-Lax‌, which patients will receive twice a day, similar to the control group. The placebo will be similar in color, shape, and weight to the C-Lax tablet made by the Dineh Iran company. Standard treatment group: This group will be treated twice a day as usual with C-Lax made by Dineh Iran Company. Severe constipation on the Bristol chart and , Patient Assessment of Constipation and Symptoms. Timepoint: Before and after the intervention. Method of measurement: Bristol chart, Patient Assessment of Constipation and Symptoms. Quality of life score in the Constipation Patient Quality of Life Assessment Questionnaire. Timepoint: Before and after the intervention. Method of measurement: Patient Assessment of Constipation-Quality of Life. The amount of fiber in the diet. Timepoint: Before and after the intervention. Method of measurement: 24-hour food recall questionnaire. Shiraz University of Medical Sciences Approved 2021-04-20 Ethics committee of Shiraz University of Medical Sciences Fars Province, Shiraz, Zand Shiraz Fars Iran (Islamic Republic of)