Clinical trial NCT04763382: The Effect of Nursing Interventions for Clean Intermittent Catheterization Caregivers and Child
Official title: The Effect of Nursing Interventions for Clean Intermittent Catheterization on Knowledge / Skills, Coping / Adaptation, Anxiety and Infection Development in Child Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intermittent Urethral Catheterization
Spinal Dysraphism
Urinary Tract Infections
Keywords: Anxiety
Child
Nurses
Urinary Tract Infection
Intermittent Urethral Catheterization
Quality of Life
Caregivers
Mobile Applications
Smartphone
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 27
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The caregivers in experimental group of study were given health training on CIC application, and after the training, the guide booklet was delivered to the participants, the android phone application. After discharge of three urinalysis, three phone calls and home visit. The data collection tools applied to aregivers in experimental group as a pre-test were also applied post-test and retention test. The same data collection tools were applied to control group for pre-test. The caregivers in the control group were not trained, android applications were not installed on their phones, home visits. With the routine practice given in the hospital, he was provided with CIC training. However, one month after discharge, he was asked to give urinalysis once a month for three consecutive months. Urinalysis was taken three times in total. Data collection tools, which were applied as a pre-test when they gave the second urinalysis, were applied again as a post-test.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Being literate
* Having a smart phone with an android application
* He should not have received information from the nurse about CIC application.

The children included in our research;

* Between the ages of 0-17
* Karadeniz Technical University Farabi Hospital Pediatric Nephrology Department decided to apply and implement CIC
* It should not have a complex congenital anatomical anomaly of the urogenital system

Exclusion Criteria:

* Being 18 years old and above
* Being a communication problems
* Having mental confusion or any psychiatric problem caregiver
* Not volunteering to participate in the research
* Not have androıd smart phone

Primary outcomes:
measure: knowledge / skill level of caregivers.
timeFrame: Change from knowledge / skill level of caregivers at 3 months
measure: The coping / adaptation scala of the caregivers.
timeFrame: Change from the coping / adaptation level of caregivers at 2 months
measure: Anxiety Level of caregivers
timeFrame: Change from anxiety level of caregivers at 2 months
measure: Urinary infection in the child.
timeFrame: Change from Urinary infection in the child at 2 months
measure: Roy adaptatıon model question form
timeFrame: Change from at 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Techical University Health Faculty of Health Sciences
state: Health Faculty Of Health Sciences
city: Trabzon
country: Turkey
facility: Karadeniz Technıcal University
state: Health Faculty Of Health Sciences
Study officials:
affiliation: Karadeniz Technical University
name: CANAN SARI, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA; Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. doi: 10.1086/651091. No abstract available.
citation: Lapides J, Diokno AC, Gould FR, Lowe BS. Further observations on self-catheterization. J Urol. 1976 Aug;116(2):169-71. doi: 10.1016/s0022-5347(17)58730-3.
citation: Singh R, Rohilla RK, Sangwan K, Siwach R, Magu NK, Sangwan SS. Bladder management methods and urological complications in spinal cord injury patients. Indian J Orthop. 2011 Mar;45(2):141-7. doi: 10.4103/0019-5413.77134.
citation: Neveus T, von Gontard A, Hoebeke P, Hjalmas K, Bauer S, Bower W, Jorgensen TM, Rittig S, Walle JV, Yeung CK, Djurhuus JC. The standardization of terminology of lower urinary tract function in children and adolescents: report from the Standardisation Committee of the International Children's Continence Society. J Urol. 2006 Jul;176(1):314-24. doi: 10.1016/S0022-5347(06)00305-3.