This randomized clinical trial was conducted in the pediatric intensive care unit of Amir-al-Momenin Hospital in Zabol, Iran, from February 2024 to September 2024. The inclusion criteria for children were age 6 - 12 years, a diagnosis of diabetes for 6 months to 1 year, a score below 47 on the SDSCA measure (
16), no diabetes education during the previous month, and no history of other physical or mental illnesses according to medical records. The inclusion criteria for mothers were no caregiving responsibilities for another chronically ill patient, no known mental, neurological, or chronic illness, and willingness to participate.
The total sample size was 60 child-mother pairs, calculated based on the results of a previous study by Farahaninia (
17), with 99% confidence, 80% power, and an allowance for 50% attrition, using the mean difference formula:
The minimum sample size for each group was 19 patients. Participants were selected using convenience sampling and then allocated to 3 groups by simple random sampling: teach-back, multimedia, and control.
To randomly assign participants to groups, 60 sheets of paper of identical shape and size were prepared. Twenty sheets were labeled "control group," 20 were labeled "teach-back group," and 20 were labeled "multimedia group." The sheets were folded, placed in a container, and mixed. Upon admission of each patient, the researcher drew 1 sheet from the container to determine group assignment. Participants were unaware of the existence of other groups.
In the teach-back group, educational content was explained individually to the patient, and questions and ambiguities were addressed. At the end of each session, to ensure the client’s understanding, the content was assessed using open-ended questions. If necessary, the topics were repeated. This process continued until the end of the client’s treatment. At the beginning of each session, the previous session’s training was reviewed using open-ended questions, and the prior content was repeated as needed. The material taught at the end of the first session was provided to the client in booklet form (
Table 1).
| Session | Content |
|---|
| 1 | Provided education on diabetes, its causes, complications, and strategies for preventing complications. |
| 2 | Provided essential training on diet, meal frequency, and appropriate snack consumption. |
| 3 | Provided instruction on insulin injection techniques and appropriate injection sites. |
| 4 | Provided training on blood glucose monitoring, appropriate testing times, and foot care. |
In the multimedia group, training was delivered via videos and digital files sent to a mobile device. The educational content consisted of 5 videos covering the same material taught in person to the teach-back group.
The control group received only routine hospital education, which included standard instruction from a physician or nurse and informational posters. Data were collected using a demographic questionnaire, the SDSCA scale, and HbA1c testing.
The demographic questionnaire included age, sex, education level, hospitalization rate, insurance status, duration of diabetes, residence, maternal age, maternal education level, family financial status, and maternal occupation. The SDSCA was used to assess diet, physical activity, blood glucose monitoring, and insulin injection. In the another study, the average content validity index was reported as 84.9%, and Cronbach alpha was 0.78. HbA1c levels were measured using standard laboratory techniques with a Hitachi 7180 automatic biochemical analyzer (Japan). All HbA1c metabolic tests in children were performed in 1 laboratory. The reliability of the laboratory instrument was assessed by checking the device calibration each time it was used. In addition, all tests were performed in the same environment by the same person using the same device.
Before the intervention, all 3 groups completed the questionnaires, and the children’s HbA1c levels were measured. The questionnaires were completed by the child’s mother. The number of training sessions was based on individual learning needs, with an average of 4 one-on-one sessions, each lasting 30 - 45 minutes and conducted once per day. The training covered essential diabetes self-care topics, including diet, physical activity, blood glucose monitoring, and insulin injection, as identified by the SDSCA. One month after the final session, the questionnaire was administered again, and HbA1c levels were remeasured by blood test 3 months later (
4). Data were analyzed using IBM SPSS version 22, which was selected because it supports the planned descriptive analyses, analysis of variance, chi-square/Kruskal-Wallis tests, and post hoc analyses.
The study received ethical approval from the Ethics Committee of Zabol University of Medical Sciences (approval code: IR.ZBMU.REC.1402.079). Written informed consent was obtained from all mothers, and participant confidentiality was ensured by assigning a code to each participant. Participants were free to withdraw from the study at any time.