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Clinical Trial Summary

In neurogenic or non-neurogenic bladder disorders, the removal process after the catheter is inserted into the bladder and the urine has been drained is called Clean intermittent catheterization (CIC). After 1972, Lapides started using CIC in the treatment of people who cannot empty their bladder on their own. The decision to apply CIC to patients is made by the doctor. After CIC application, patients's increase body image, self-confidence development and quality of life. CIC application to children is done by caregivers. CIC use has negative effects as well as positive effects for patients. If the caregiver has not received enough training about CIC application and does not pay attention to CIC performing hours and procedure steps, urinary tract infection can be seen in children. Common urinary tract infections in children cause permanent kidney damage. Studies conducted to prevent complications that may develop in patients using CIC emphasize the importance of patient education. The aim of this study is to evaluate the effect of based on the roy adaptation theory supported android phone application CIC training, on the knowledge / skills, coping / adaptation and anxiety level of caregivers and the development of urinary tract infection in children.


Clinical Trial Description

Background: It is the bladder, one of the organs with important functions in the urinary system. However, the bladder sometimes cannot work effectively as a result of neurological and sometimes non-neurological reasons. After this situation, urine in the bladder should be emptied. The bladder is one of the most frequently used organs in the urinary system. In neurogenic or non-neurogenic bladder disorders, the process of entering the bladder with a catheter in clean conditions, evacuating urine, and then removing the catheter is called Clean Intermittent Catheterization (CIC). CIC has been used by patients for nearly 40 years. CIC is one of the effective methods used to protect the urinary system, especially in children with Spina Bifida and people with urinary system problems. CIC application to children is done by caregivers. In the education of caregivers who have to apply CIC to their child the role of nurse to become more and more important. The aim of this study is to evaluate the effect of based on the roy adaptation theory supported android phone application CIC training, on the knowledge / skills, coping / adaptation and anxiety level of caregivers and the development of urinary tract infection in children. Metod: The universe of the study consisted of the patients and their caregivers who were decided to perform CIC by Karadeniz Technical University Farabi Hospital Pediatric Nephrology Department. In order to determine the sample of the study, the test power in power analysis was calculated with the G * Power 3.1 program. 95% confidence interval in determining the strength of the study; With 5% significance level and 0.50 effect size a total of 36 patients (df = 1; F = 4.130). 36 conforming patients were divided into experimental and control groups for a single- blind randomized control. The data will be collected using the introductory information form, the CIC application knowledge and skills form, based on North American Association of Nursing Diagnoses (NANDA) nursing diagnoses and Psychosocial Adaptation Area of Roy Adaptation Model form, Coping and Adaptation Scale and State Trait Anxiety Scale. In addition, for the diagnosis of urinary tract infection in participants undergoing CIC, urinalysis will be performed once a month, three times for three months. Patients with 100,000 colonies per milliliter of urine for urinalysis will be considered to have a urinary tract infection. No additional intervention will be made to caregivers in the control groups. Caregivers in the intervention group (Caregivers who will receive CIC training supported by Android phone application based on Roy adaptation model) will be given CIC training, home visit, and telephone conversation. In addition, an android phone application will be installed on the phones of the caregivers in the intervention group, which reminds the CIC times, procedure steps and hospital appointments. The data will be analyzed using SPSS versiyon with descriptive statistics, Independent t test and Anova in repeated measurements p<0.05 will be statistically significant ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04763382
Study type Interventional
Source Karadeniz Technical University
Contact
Status Active, not recruiting
Phase N/A
Start date March 23, 2020
Completion date May 25, 2021

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