跳至主要内容
临床试验/NCT04763382
NCT04763382Unknown不适用

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

Karadeniz Technical University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Urinary infection in the child.

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

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.

入排标准

年龄范围
27 Days 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: experimental group: Training of caregivers (Other)

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.

干预措施: Control gruop (Other)

结局指标

主要结局

Urinary infection in the child.

时间窗: Change from Urinary infection in the child at 2 months

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.

Roy adaptatıon model question form

时间窗: Change from at 2 months

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

Anxiety Level of caregivers

时间窗: Change from anxiety level of caregivers at 2 months

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.

knowledge / skill level of caregivers.

时间窗: Change from knowledge / skill level of caregivers at 3 months

The data collection tool used is not a scale. Created by researchers in line with the literature

The coping / adaptation scala of the caregivers.

时间窗: Change from the coping / adaptation level of caregivers at 2 months

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Canan Sari

Principal Investigator

Karadeniz Technical University

研究点 (2)

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