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

NCT04763382 | Unknown DMC

• 1 other identifier: Nurse_clean intermittent cat.
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Roy adaptatıon 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

Study Arms (2)

Experimental grups: Training of caregivers

OTHER

1. Application of data collection: Tools as pre-test, post-test and retention test to participants in the experimental group, 2. Education:It includes the training given to the caregivers in the experimental group, delivery of the guide booklet at the end of the training 3. Android phone application: Installing on the phones of the caregivers in the experimental group of the android application, which includes the frequency of CIC application, the CIC application process steps and hospital appointments, created by the nurse for the caregivers in the experimental group and the software is made by the computer engineer. 4. One home visit and three phone calls were made in order to solve the problems that the caregivers in the experimental group experienced with the use of CIC or android use. 5. Urinalysis for children who are inserted and put into the study:All participants in the study were asked to give urine tests three times with an interval of one month after discharge.

Other: experimental group: Training of caregivers

Control: Control grups

OTHER

1. As in the experimental group, the caregivers in the control group were pre-tested and post-tested using data collection tools. 2. No intervention was made to the caregivers in the control group. 3. However, caregivers in the control group performed urinalysis three times with an interval of one month after discharge.

Other: Control gruop

Interventions

experimental group: Training of caregivers OTHER

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

Experimental grups: Training of caregivers

Control gruop OTHER

Pre-test, post-test and urinalysis

Control: Control grups

Eligibility Criteria

• Age: 27 Days - 17 Years
• Gender Eligibility Details: Participants are 9 boys and 31 girls. While randomization, grouping was made according to gender. 4 of the boys were in the experimental group and 5 were in the control group.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (2)

Karadeniz Techical University Health Faculty of Health Sciences

Trabzon, Health Faculty of Health Sciences, 61080, Turkey (Türkiye)

Location

Karadeniz Technıcal University

Trabzon, Health Faculty of Health Sciences, 61080, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 20156062 RESULT

• 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.

  PMID: 950697 RESULT

• 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.

  PMID: 21430869 RESULT

• 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.

  PMID: 16753432 RESULT

• Sari C, Demirbag BC. The effect of model-based android phone application supported clean intermittent catheterization training on caregivers and children: A randomized controlled study. Eur J Pediatr. 2024 Nov 27;184(1):46. doi: 10.1007/s00431-024-05890-z.

  PMID: 39601932 DERIVED

MeSH Terms

Conditions

Spinal Dysraphism; Urinary Tract Infections; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Mental Disorders

Study Officials

• CANAN SARI, PhD student

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 21, 2021
• Study Start: March 23, 2020
• Primary Completion: June 20, 2020
• Study Completion: May 25, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)