Investigating the influence of Mobile-Based dietary program education on Constipation Management and quality of life of Peritoneal dialysis patients

Determining the effect of mobile-based diet plan training on constipation management and quality of life of peritoneal dialysis patients

Phase 3 randomized clinical trial on 30 patients, two arms with active control, Single-blind. Block randomization with random sequence generation software

The present study is a double-blind clinical trial that has been compiled using the criteria of the 2010 concert checklist. This study will be performed as a pre-test and post-test with an intervention and control group in Shiraz University of Medical Sciences Peritoneal Dialysis Centers in 2021. physicians, evaluators, educators, statistical analyzers are blinded in this study.

inclusion criteria: 30 patients (+18 y) with symptoms of constipation at the time of screening and scoring 1 and 2 on the Bristol chart. Exclusion criteria: current use of Constipation-Causing Medications, pregnancy or lactation, history of alcohol use or drug abuse, history of thyroid disease in oneself and family, dementia, colitis, irritable bowel syndrome.

Intervention group for 4 weeks, mobile diet training + placebo; C-Lax‌ placebo, administered twice daily 5 Session 10-minute In the form of Meetings in absentia (WhatsApp software), on days 1-5. Educational content: 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.

Constipation status before and after the intervention, assessment with PAC-SYM questionnaire and Bristol chart; Quality of life before and after the interventions, assessment with the PAC-QOL questionnaire.

Writing problems

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.

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.

All data is potentially shareable after unidentified individuals.

Access period starts 6 months after the results are published.

It will be available only to researchers working in academic and scientific institutions.

The results of the study can be used to complete the research of academic researchers on dialysis patients and patients with constipation.

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

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.