This study is an interventional study with two groups that was conducted in 2015 in Ghaem Hospital of Mashhad. Sampling method was available. A pilot study was used to determine the sample size. In calculating the sample size, 95% confidence level and 80% test power were considered. Finally, the highest sample size was related to the alkaline transferase aminase variable, which was equivalent to 44 people in each group; However, due to the lack of research units, 77 people (45 people in the intervention group and 32 people in the control group) were included in the study.
Inclusion criteria were: Children with liver disease with a history of at least 6 months of disease, Iranian citizenship and resident of Mashhad, Having written consent to participate in the study, Ability to make telephone calls to children over 8 years old, No physical or mental health restrictions other than chronic liver disease in children, Age range 2 to 18 years. Exclusion criteria were: unwillingness to participate in the study, Requires Total Parenteral Nutrition, Requires tube feeding.
The inclusion criteria for a competent caregiver were: Willingness to participate in the study, Have Junior High School degree and above, Ability to make phone calls. Exclusion criteria for a competent caregiver were: Reluctance to continue cooperation, Not participating in workshops.
Initially, the necessary permits were obtained from the ethics committee of Mashhad University of Medical Sciences. Then the researcher started sampling by referring to the sampling place and presenting the sampling permit and explaining the research objectives and research stages. Sampling was done through the HIS system of the hospital and the files available in the gastrointestinal clinic of Ghaem Hospital. In the HIS system of Ghaem Hospital, the keywords of chronic liver disease, cirrhosis, ascites, biliary atresia, neonatal idiopathic hepatitis, congenital metabolic diseases, autoimmune hepatitis, Wilson disease, chronic viral hepatitis, chronic hepatitis were searched. Patients who were eligible for the study based on the contents of the file entered in the HIS system were contacted by telephone. Patients who were willing to cooperate were then asked to participate in the present study. After collecting demographic information, participants were randomly divided into two groups of intervention and control using a table of random numbers. Using the lottery method, it was decided to invite the intervention group of even days and the control group of single days. The selected samples (by the SIM card intended for this purpose) were invited to attend the special clinic of Ghaem Hospital on a specific date (for liver examination and other variables). In this research, the working method consisted of 3 stages (before the workshop, the course of the workshop, and the period after the workshop).
A - Before holding the workshop:
At the first visit of the research units to the nutrition and diet therapy clinic of Ghaem Hospital, they were visited by a nutritionist. In this meeting, the researcher introduced himself and the purpose of the research to a competent caregiver. After satisfying the participants to participate in the study, the researcher completed a demographic information questionnaire based on the statements of the competent caregiver and the patient file. The researcher examined the 3-day food intake of the children participating in the study and developed a 24-hour 3-day reminder by asking the competent caregiver. At the same time, blood samples were taken from the participants to measure bilirubin level (total, direct), albumin level, PT, INR, transaminases (AST, ALT). Samples taken by the researcher were sent by the Cold Box to the laboratory of the Biochemistry and Nutrition Research Center. At the end of this session, the researcher invited the intervention group to attend the workshop sessions on a specific date.
The workshops were held for 6 sessions in two weeks. The control group was asked to return to the clinic 12 weeks after the first visit. The researcher reminded the meetings of the workshop by calling the research units of the intervention group. He also reminded the research units of the control group about the time to return to the clinic by phone.
B- The stage of holding the workshop
The workshops were held for 6 sessions in two weeks. The workshops were held in the graduate building classes of the Faculty of Nursing and Midwifery of Mashhad University of Medical Sciences. The content presented at the meetings were:
First session:
Topics discussed in this session were: content related to liver function and nutrition, introduction of proteins and fats and vitamins, introduction of chronic liver disease. At the end of the session, the presented materials were printed and given to the participants (competent caregivers).
second session:
The topics discussed in this session were: clinical findings of chronic liver disease, malnutrition, intolerance and damage related to digestion, changes in the metabolism of proteins and fats.At the end of the session, the presented materials were printed and given to the participants (competent caregivers).
third session:
In this session, the topics discussed were: introduction and calculation of energy for the child and the share of carbohydrate calories in the child's diet, how to calculate and select carbohydrates for the child. At the end of the session, the presented materials were printed and given to the participants (competent caregivers).
fourth Session:
In this meeting, the topics discussed were: introduction and calculation of fat and protein, the caloric content of fat and protein in the child's diet, how to calculate fat and protein in the child's diet, recognizing sources of fat and protein useful for children with chronic liver disease. At the end of the session, the presented materials were printed and given to the participants (competent caregivers).
fifth meeting:
The topics discussed in this session were: introduction of minerals and vitamins, how to calculate minerals and vitamins. Content presentation was using PowerPoint. At the end of the session, the presented materials were printed and given to the participants (competent caregivers).
Sixth Session:
The topics discussed in this session were: a practical session to calculate the total energy, carbohydrates, proteins, fats and vitamins by a researcher and competent caregivers, reviewing the material presented in previous sessions. Practical practice to ensure sufficient patient care competence for the above calculations and choices. At the end, the patient's guide was given to the competent caregivers in the form of a booklet.
C- Stage after the workshop
After the sixth session, the follow-up phase of the study participants began. This stage included 12 weeks. During these 12 weeks, the competent caregiver had to apply to the patient what he or she had learned during the workshop sessions. To ensure this goal, three tools were used: telephone calls, regular counseling sessions, 3-day Recall 24-hour forms and 24-hour Record 24 hours.
After 12 weeks, PT, INR, bill, Alb, AST, ALT liver specific tests were performed in both control and intervention groups. The stationery that was considered as a gift was given to the research units of the control and intervention group. After collecting the data, the test results were given to the caregiver to be used in the periodic evaluation of the patient's routine in terms of the above variables.
In order to comply with the ethical principles, 6 workshop sessions and a 12-week follow-up phase that was held for the intervention group were also held for the control group and the nutritional adjustment guideline was provided to the parents of the children in the control group. This study did not pose a risk to the participants.
After completing the data, the obtained information was entered into the computer and analyzed using SPSS software.