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Prevalence of Intra-Dialytic Complications and Associated Risk Factors Among Patients on Maintenance Hemodialysis in Dongola City, Sudan, 2026.

ETH-20261023-0246 تاريخ التقديم: Oct 23, 2026 / Submitted: Oct 23, 2026
قيمة الرسوم / Payment Amount
6,000.00 SDG
نوع البحث / Research Type
بكالوريوس / Bachelor's
فترة الدراسة / Study Period
Sep 20, 2026 - Dec 01, 2026
Pending
السودان - الولاية الشمالية
وزارة الصحة
الادارة العامة للتخطيط والتنمية الصحية
إدارة البحوث
لجنة الموافقة الأخلاقية
طلب الموافقة الأخلاقية - Ethical Approval Request Form
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Ethical Approval Request Form
General Administration for Planning and Health Development
Research Department
Ethical Approval Committee
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رقم التسلسل
Serial Number
SER-20261023-0246
رقم الطلب
Request Number
ETH-20261023-0246
تاريخ تقديم الطلب
Date of Submission
2026-10-23

القسم الأول: معلومات الباحث / Principal Investigator Information

1. الاسم الكامل للباحث الرئيسي
Principal Investigator Full Name
عثمان محمد عثمان محمد احمد
2. الجهة التي ينتمي إليها
Affiliation Type
جامعة / University: Dongola university - college of medicine
Dongola university - college of medicine
3. الوظيفة / اللقب العلمي
Job Title/Academic Degree
-
4. البريد الإلكتروني
Email Address
osmanmohamed8008@gmail.com
5. رقم الهاتف
Phone Number
0114819130
المشرف / Supervisor
الاسم الكامل / Full Name
د.محمد الشيخ سعيد
البريد الإلكتروني / Email
-
الوظيفة / اللقب العلمي / Job Title
Associate Professor of Physiology
رقم الهاتف / Phone
+249 91 694 1111
القسم / المؤسسة / Department
Department of physiology

القسم الثاني: تفاصيل الدراسة البحثية / Research Study Details

7. عنوان الدراسة
Study Title
Prevalence of Intra-Dialytic Complications and Associated Risk Factors Among Patients on Maintenance Hemodialysis in Dongola City, Sudan, 2026.
8. نوع البحث (يرجى التحديد)
Type of Research (Please select)
☐دكتوراه / PhD
☐ماجستير / Master's
☑بكالوريوس / Bachelor's
☐دبلوم عالي / Postgraduate Diploma
☐دبلوم وسيط / Intermediate Diploma
☐ورقة علمية / Research Paper
☐تقرير علمي / Scientific Report
☐أبحاث طبية / Medical Research
☐أخرى / Other
9. وصف مختصر للبحث
Brief Description of Research
My study aims to assess the prevalence of intra-dialytic complications and identify associated risk factors among patients on maintenance hemodialysis at El Gomaih Dialysis Center in Dongola City, Sudan, in 2026. It will use an analytic cross-sectional study design, collecting data on complications and patients’ demographic and clinical characteristics to determine the prevalence of these complications and explore factors associated with their occurrence.

القسم الثالث: الجوانب الأخلاقية / Ethical Considerations

10. طريقة الحصول على الموافقة من المشاركين
Method of Obtaining Consent from Participants
☐مكتوبة / Written
☑شفهية / Verbal
☐غير مطبقة / Not Applicable
☐ضمنية / Implied
☐إعفاء / Waiver
يرجى إرفاق نموذج الموافقة / Please attach consent form
11. آلية الحفاظ على سرية المعلومات
Confidentiality Measures
Participant confidentiality will be protected throughout the study. No names will be recorded on the questionnaire; each participant will be identified only by a unique code, and the medical record number will be used solely to avoid duplicate enrollment and will not be entered into the analysis. Verbal informed consent will be obtained, and participants will be informed that participation is voluntary and that they may withdraw at any time without affecting their dialysis care. Completed questionnaires and the electronic database will be stored securely and accessed only by the research team, and results will be reported in aggregate form so that no individual patient can be identified.
12. مدى المخاطر على المشاركين
Risk Level to Participants
☐لا توجد / None
☑طفيفة / Minor
☐متوسطة / Moderate
☐عالية / High
يرجى توضيح أي مخاطر محتملة وخطة التعامل معها / Please describe any potential risks and mitigation:
Potential risks to participants are minimal. The study is observational and involves no intervention, so participants will receive their usual dialysis care without any change. The only likely burdens are a short time spent answering the questionnaire during a dialysis session and possible mild discomfort from discussing symptoms. Interviews will be conducted during the session, with no extra visits needed. A breach of confidentiality is also a possible risk, which will be minimized by using coded questionnaires without names and by restricting access to the data to the research team. Participants may decline to answer any question or withdraw at any time without any effect on their care.
13. الفوائد المحتملة للمشاركين أو المجتمع
Potential Benefits to Participants or Society
There is no direct benefit to participants from taking part in this study. Indirectly, the findings will estimate how common intradialytic complications are among hemodialysis patients in Dongola and identify the risk factors associated with them. This can help the dialysis centers recognize high-risk patients earlier, improve monitoring and the prevention of complications during sessions, and support better quality of care. The results may also provide local data for future research and for health planning in Sudan.
14. هل تشمل الدراسة فئات ضعيفة؟
Does the study involve vulnerable groups?
☐الأطفال / Children
☐النساء الحوامل / Pregnant Women
☐اللاجئون/النازحون / Refugees/Displaced
☐ذوو الإعاقة / People with Disabilities
☐أخرى / Other:

القسم الرابع: قائمة المرفقات المطلوبة / Required Attachments

نسخة من المقترح البحثي الكامل
Full Research Proposal
أدوات جمع البيانات
Data Collection Tools
نموذج الموافقة
Consent Form
خطاب تسهيل من الجامعة
University Facilitation Letter

القسم الخامس: الإقرار والتوقيع / Acknowledgment and Signature

أُقر أنا الموقع أدناه بأن جميع المعلومات الواردة في هذه الاستمارة صحيحة وكاملة، وأتعهد بعدم البدء في أي جزء من الدراسة قبل الحصول على الموافقة الأخلاقية الرسمية، والالتزام بجميع الإرشادات والمعايير الأخلاقية المعتمدة من قبل لجنة الموافقة الأخلاقية.
I, the undersigned, acknowledge that all information provided in this form is accurate and complete, and I agree not to begin any part of the study before receiving official ethical approval, and to comply with all ethical guidelines and standards approved by the Ethical Approval Committee.
اسم الباحث الرئيسي / Principal Investigator Name
عثمان محمد عثمان محمد احمد
التوقيع / Signature
_______________________
التاريخ / Date
2026-10-23

معلومات الباحث / Researcher Information

�

عثمان محمد عثمان محمد احمد

osmanmohamed8008@gmail.com

0114819130

جامعة: Dongola university الكلية: college of medicine
�

احمد السيد خلف الله السيد

sydahmd1330@gmail.com

0114721330

جامعة: Dongola university الكلية: college of medicine

El gomaih Dialysis center

اسم المؤسسة التي سيتم فيها عمل البحث / Name of the institution where the research will be conducted

Dongola

معلومات الدراسة / Study Information

بكالوريوس / Bachelor's

بكالوريوس - Bachelor

6,000.00 SDG

My study aims to assess the prevalence of intra-dialytic complications and identify associated risk factors among patients on maintenance hemodialysis at El Gomaih Dialysis Center in Dongola City, Sudan, in 2026. It will use an analytic cross-sectional study design, collecting data on complications and patients’ demographic and clinical characteristics to determine the prevalence of these complications and explore factors associated with their occurrence.

Sep 20, 2026 - Dec 01, 2026

Nov 01, 2026 - Nov 30, 2026

الاعتبارات الأخلاقية / Ethical Considerations

Verbal

مخاطر منخفضة - Low Risk

Participant confidentiality will be protected throughout the study. No names will be recorded on the questionnaire; each participant will be identified only by a unique code, and the medical record number will be used solely to avoid duplicate enrollment and will not be entered into the analysis. Verbal informed consent will be obtained, and participants will be informed that participation is voluntary and that they may withdraw at any time without affecting their dialysis care. Completed questionnaires and the electronic database will be stored securely and accessed only by the research team, and results will be reported in aggregate form so that no individual patient can be identified.

Potential risks to participants are minimal. The study is observational and involves no intervention, so participants will receive their usual dialysis care without any change. The only likely burdens are a short time spent answering the questionnaire during a dialysis session and possible mild discomfort from discussing symptoms. Interviews will be conducted during the session, with no extra visits needed. A breach of confidentiality is also a possible risk, which will be minimized by using coded questionnaires without names and by restricting access to the data to the research team. Participants may decline to answer any question or withdraw at any time without any effect on their care.

There is no direct benefit to participants from taking part in this study. Indirectly, the findings will estimate how common intradialytic complications are among hemodialysis patients in Dongola and identify the risk factors associated with them. This can help the dialysis centers recognize high-risk patients earlier, improve monitoring and the prevention of complications during sessions, and support better quality of care. The results may also provide local data for future research and for health planning in Sudan.

Elderly Economically disadvantaged