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The Effect of Nursing Interventions for Clean Intermittent Catheterization Caregivers and Child

The Effect of Nursing Interventions for Clean Intermittent Catheterization on Knowledge / Skills, Coping / Adaptation, Anxiety and Infection Development in Child Caregivers

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04763382
Enrollment
40
Registered
2021-02-21
Start date
2020-03-23
Completion date
2021-05-25
Last updated
2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

OTHERexperimental group: Training of caregivers

Pre-test, post-test, retention test, education, guide booklet delivery, android application installation and urinalysis

OTHERControl gruop

Pre-test, post-test and urinalysis

Sponsors

Karadeniz Technical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Because the initiative of the study is based on education. While obtaining informed consent, the purpose and content of the study were explained to the participants. For this reason, the trainees know that they are in the experimental group, and those who do not receive training in the control group.

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.

Eligibility

Sex/Gender
ALL
Age
27 Days to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
knowledge / skill level of caregivers.Change from knowledge / skill level of caregivers at 3 monthsThe data collection tool used is not a scale. Created by researchers in line with the literature
The coping / adaptation scala of the caregivers.Change from the coping / adaptation level of caregivers at 2 monthsÇatal in 2015. The Coping and Adaptation Processing Scale (CAPS) is a 47-item instrument using a Likert scale format with response choices ranging from 4 (always) to 1 (never). Each item of the CAPS is a short statement about how an individual responds to experiencing a crisis or extremely difficult event. Fourteen items are reversed scored. The possible range of scores is from 47 to 188 with a high score indicating a more consistent use of the identified strategies of coping.
Anxiety Level of caregiversChange from anxiety level of caregivers at 2 monthsState and Trait Anxiety Scale (STAI) will be used to assess the anxiety levels of caregivers. The scale was created in 1964 by Speilberger and Gorsuch. The scale was adapted to Turkish in 1975 by Öner and Le Compte. The scale consists of two parts, each consisting of 20 items. the first part is the state anxiety scale part. Grouped as (1) None, (2) A little, (3) Much, and (4) All. There are ten reversed statements in the state anxiety scale. These are Articles 1, 2,5, 8, 10, 11, 15, 16, 19 and 20. Trait Anxiety Scale is the second part of the scale. Grouped as (1) Almost never, (2) Sometimes, (3) A lot of time, and (4) Almost always. Reversed on the trait anxiety scale there are expressions. These statements are 21, 26, 27, 30, 33, 36 and 39. The scores obtained from each scale range from 20 to 80. The higher the scores obtained from the scale, the higher the anxiety level.
Urinary infection in the child.Change from Urinary infection in the child at 2 monthsUrine analysis will be performed to evaluate the development of urinary tract infection in children undergoing CIC.The diagnosis of urinary tract infection in children will be made in accordance with the literature with the presence of 100,000 colony bacteria in the urine.
Roy adaptatıon model question formChange from at 2 monthsQuestion form created by adhering to NANDA-I nursing diagnoses based on the concepts in the Roy Adaptation Model and the stimuli in the model.The data collection tool used is not a scale. Created by researchers in line with the literature

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026