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The objective of the study will be to assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group.To assess usefulness of diet related mobile application in comparison to usual care group.To identify diet related problems among children post cardiac surgery in both groups (usual care group and intervention group ).
Research question Is there any impact of artificial intelligence on nutritional status of children post cardiac surgery?
Null hypothesis:
There is no impact of artificial intelligence on nutritional status of children post cardiac surgery
Operational definition:
Material and Methods:
STUDY DESIGN:
Randomized controlled trial
SETTING:
Tertiary Care Cardiac hospital, Rawalpindi , Pakistan.
SAMPLING TECNIQUE:
Permuted block BLINDING Double blinded study
SAMPLE SIZE:
Sample size is estimated to be 96, 48 in each group i.e. intervention and control group
DATA ANALYSIS PROCEDURE All data will be analyzed using SPSS 23 Descriptive statistics
Ethical consideration The study will start after presenting research proposal and obtaining ethical approval from Ethical Review Committee of Pakistan Institute of Ophthalmology, Al-Shifa School of Public Health. A formal letter will be used that will include the information relevant to the study e.g., the purpose and duration of this study, the level of privacy and confidentiality of information with anonymity of the respondents. While conducting this study, informed consent from all participants will be taken verbally and in written form. Participation will be voluntary and individuals will be informed that they can withdraw at any time and that all data will be treated confidentially. Subjects will be assured of anonymity and confidentiality. Patients will be given a broad outline of the research, an indication of the type of information that is required, the reasons why the research is being carried out and how the information which they provided will be used.
Independent variable
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI group | Experimental |
|
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| usual care group | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile based application | Device | Application basic function would be support and improve nutrition status of children. Personalization of goals and challenges, daily intake of calories, carbohydrates, proteins, fats, minerals and vitamins will be tracked, food logging, food tracking, meal and supplement reminders, recipes, visual cues (remaining calories) will be notified, episodes of vomiting, meals missed, diarrhea, nausea will be recorded , meal planned according to the food preferences of child, food composition table, nutrition blogs and articles |
| Measure | Description | Time Frame |
|---|---|---|
| Weight changes | observe the Weight changes , weight for age , Z score weight for age in both groups | 2 months |
| Caloric intake | Check the average calories intake consumed in both groups | 2 months |
| Proteins intake | Check the average proteins consumed in both groups | 2 months |
| Mobile application usage | Patients will be asked whether the language used in application on a likert scale ranging from very easy to very difficult , handling application will be ranging from very easy to very difficult, cost effectiveness will be ranging from yes to very costly, Visual cues in application will be ranged from useful to difficult to understand, Recipes in application will be ranged from being Useful to not useful, Meal reminders will be ranged from being useful to irritating | 2 months |
| nutritional issues | Patient will be inquired regarding the episodes of vomiting, diarrhea, loss of appetite and other nutritional related problems | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| carbohydrates intake | Measure average carbohydrates consumed in both groups (intervention and usual care group) in mg | 2 months |
| fats intake | Measure average fats consumed in both groups (intervention and usual care group) in mg |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Armed Forces Institute of Cardiology and National Institute of Heart Disease | Rawalpindi | Punjab Province | 46000 | Pakistan | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38618548 | Derived | Zahid M, Sughra U, Mumtaz S, Hassan M. Improving nutritional status of children using artificial intelligence-based mobile application postsurgery: randomised controlled trial. BMJ Nutr Prev Health. 2023 Dec 2;6(2):367-373. doi: 10.1136/bmjnph-2023-000645. eCollection 2023. | |
| 35713054 | Derived | Zahid M, Sughra U. Development of a protocol for conducting a randomized control trial on effects of artificial intelligence on nutritional status of children post cardiac surgery. J Pak Med Assoc. 2022 May;72(5):908-911. doi: 10.47391/JPMA.3751. |
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It is not yet known if there will be a plan to make IPD available.
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| Pamphlet | Behavioral | A pamphlet which will be provide knowledge to the patients |
|
| 2 months |
| Vitamins intake | Measure average vitamins consumed in both groups (intervention and usual care group) in mg and µg | 2 months |
| Minerals intake | Measure average minerals consumed in both groups (intervention and usual care group) in mg and µg | 2 months |
| Maryam Zahid |
| Rawalpindi |
| Punjab Province |
| Pakistan |