The protocol for this quasi-experimental study was approved by the Ethics Committee of Zahedan University of Medical Sciences (IR.ZAUMS.REC.1401.032). The participants included 50 patients discharged from the neurosurgery ward of the Khatam Al-Anbia Hospital of Zahedan City in 2022. After obtaining the required permits, the researcher visited the office of the hospital’s manager and received permission to conduct the research. Then arrangements were made with the head of the ward, and TBI patients and their caregivers who met the criteria for enrollment in the study were selected using convenience sampling. The participants were randomly divided into the intervention and control groups.
Inclusion criteria for patients were the diagnosis of TBI confirmed by a neurologist, consciousness level of 8 - 13 (according to the Glasgow coma scale), no urinary infection at discharge, no diabetes, age between 18 - 60 years, being a male, living in Zahedan, and having a Foley catheter or a condom sheet for emptying the bladder. Inclusion criteria for caregivers were being the main caregiver of the patient, being over 18 years old, having literacy, and living in Zahedan. Exclusion criteria for patients were readmission to the hospital during the study, unwillingness to cooperate, and withdrawal during the study. Finally, caregivers in the intervention group who missed more than one training session were also excluded from the study.
The participants were randomly assigned to either of the two study groups using color cards. Fifty cards, 25 red (intervention) and 25 yellow (control) cards, were prepared and arranged randomly. The patients and caregivers who consecutively entered into the study were randomly assigned a card to determine their group membership. According to Rintala et al., taking a 95% confidence interval and 95% test power, the sample size was estimated as n = 13 per group using the following formula (
26). Taking into account any probable dropout and in order to improve the study’s rigor, the sample size in each group was estimated to be n = 25 (50 subjects in total).
The researcher provided some instructions about the objectives of the study and research procedures to caregivers in the hospital and invited them to participate in the study. The caregivers were also ensured that participation in the study was voluntary and their information would be kept confidential. Moreover, informed written consent was obtained from the participants, who were also told that they could leave the study at any time they wished, and their withdrawal would have no effect on the treatment process of their patients.
The data were collected using a demographic information questionnaire, and urine culture test results were recorded. The caregivers in the intervention group attended two 45-minute face-to-face training sessions. The first session was held on the second day after discharge and the second session on the fifth day after discharge at the patient’s home (
Table 1). In addition, an educational pamphlet was delivered to the caregivers, and an educational video was played for them to show the correct catheterization and catheter care methods. After the last training session, the researcher communicated with the caregivers every two weeks by phone and provided the necessary instructions. Moreover, a phone number was provided to the main caregiver to contact the researcher if they needed any additional information. A urine sample was taken from each patient in the intervention group by a sterile method at the patient’s home and sent to the laboratory to check for UTIs. The patients and caregivers in the control group only received routine training. Similar to the patients in the intervention group, their counterparts in the control group were examined for UTIs after four weeks of hospital discharge.
| Session | Place | Time | Duration | Content |
|---|
| 1 | At the patient’s home | Day 2nd after discharge | 45 min | Acquaintance with the patient and caregiver, explaining traumatic brain injury, its complications, and long-term risks for patients |
| 2 | At the patient’s home | Day 5th after discharge | 45 min | Explaining urinary infections and their underlying mechanisms, educating the correct catheterization methods and urinary infection preventive measures |
To collect urine samples, the researcher first wore gloves; the patient’s urinary catheter was clamped for about 30 minutes before connection to the urinary bag, and then the place where the needle entered the catheter was disinfected with 70% alcohol. Twenty mL of urine sample was drawn into a syringe and transferred into a sterile container, which was labeled with the patient’s information and sent to the laboratory in less than half an hour (
27). The urine sample was cultured in the laboratory using the calibrated loop method in blood agar and EMB media. The plates were placed in an incubator at 37°C for 48 hours. If no colony grew, the test result was reported as negative, but in the plates in which colonies grew, the number of colonies was determined and multiplied by the volume of the lobe. If the number of colonies was 10
5 per mL or more, the test result was considered positive, confirming the diagnosis of UTI.
To comply with ethical protocols, all the educational content provided to the participants in the intervention group was also offered to the participants in the control group in the form of a booklet. Moreover, the necessary arrangements were made for all patients to receive a doctor’s visit at the end of the study.
The data collected were analyzed by SPSS 21 software. The independent samples t-test was used to compare quantitative variables between the two groups. Moreover, the Chi-square test was used to compare qualitative variables between the two groups. A significance level of less than 0.05 was considered for data analysis.