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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04763382
• Other study ID #: Nurse_clean intermittent cat.
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 23, 2020
• Est. completion date: May 25, 2021

Study information

• Verified date: February 2021
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 25, 2021
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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 android smart phone

Related Conditions & MeSH terms

• Infection
• Intermittent Urethral Catheterization
• Neural Tube Defects
• Spinal Dysraphism
• Urinary Tract Infections

Intervention

Other:
• experimental group: Training of caregivers
Pre-test, post-test, retention test, education, guide booklet delivery, android application installation and urinalysis
• Control gruop
Pre-test, post-test and urinalysis

Locations

Country	Name	City	State
Turkey	Karadeniz Techical University Health Faculty of Health Sciences	Trabzon	Health Faculty Of Health Sciences
Turkey	Karadeniz Technical University	Trabzon	Health Faculty Of Health Sciences

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Lapides J, Diokno AC, Gould FR, Lowe BS. Further observations on self-catheterization. J Urol. 1976 Aug;116(2):169-71. — View Citation

Nevéus T, von Gontard A, Hoebeke P, Hjälmås K, Bauer S, Bower W, Jørgensen 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 Commi — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knowledge / skill level of caregivers.	The data collection tool used is not a scale. Created by researchers in line with the literature	Change from knowledge / skill level of caregivers at 3 months
Primary	The coping / adaptation scala of the caregivers.	Çatal 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.	Change from the coping / adaptation level of caregivers at 2 months
Primary	Anxiety Level of caregivers	State 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.	Change from anxiety level of caregivers at 2 months
Primary	Urinary infection in the child.	Urine 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.	Change from Urinary infection in the child at 2 months
Primary	Roy adaptation model question form	Question 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	Change from at 2 months