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临床试验/NCT04813783
NCT04813783已完成不适用

The Effect of Mucositis Care Training Given to Caregivers in Pediatric Leukemia Cases on Mucosal Barrier Damage

Ege University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
change of the degree of mucositis

研究概览

简要总结

There are studies in the literature that include parent training for the prevention and care of mucositis.

Many national and international organizations have emphasized the responsibility of the nurse in patient education and stated it in the relevant laws and regulations.

The regulations focus on the educative role of the nurse for patients. In pediatric oncology clinics where leukaemia treatment and care is provided, the educational role of the nurse is directed towards the child individual and their family, and determining and meeting the educational needs of the whole family is vital in the nursing management of the child with cancer.

In this context, this study aims to examine the effect of mucositis care training to caregivers of pediatric patients aged 2 to 18 years, on the development of mucositis and the clinic's "mucosal barrier damage, laboratory-confirmed bloodstream infections".

详细描述

Children who are treated for leukaemia are exposed to a wide variety of chemotherapeutic agents and immunosuppressive treatments during the treatment, therefore they are at high risk of complications. Gastrointestinal mucositis is the leading factor affecting the quality of life of the child among the chemotherapy-related complications.

Gastrointestinal mucositis (GM) can be defined as inflammation or ulceration in the gastrointestinal organs due to chemotherapy treatment. Symptoms of GM include abdominal pain, diarrhoea, bleeding, fatigue, malnutrition, dehydration, electrolyte imbalance, and secondary infections. GM can present in two forms as oral and anal mucositis. Both oral and anal all GMs have negative effects on growth and development in children. One of the main issues of the remedial approach in this regard is the provision of qualified mucositis care. There are studies in the literature that include parent training for the prevention and care of mucositis.

Many national and international organizations have emphasized the responsibility of the nurse in patient education and stated it in the relevant laws and regulations. The regulations focus on the educative role of the nurse for patients. In pediatric oncology clinics where leukaemia treatment and care is provided, the educational role of the nurse is directed towards the child individual and their family, and determining and meeting the educational needs of the whole family is vital in the nursing management of the child with cancer.

In this context, this study aims to examine the effect of mucositis care training to caregivers of pediatric patients aged 2 to 18 years, on the development of mucositis and the clinic's "mucosal barrier damage, laboratory-confirmed bloodstream infections".

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The case is between the ages of 2-18
  • The patient is followed up in the Pediatric Hematology Clinic
  • The patient is only receiving leukaemia treatment
  • The patient is receiving chemotherapy suitable for the high-risk group (T-ALL, High Risk ALL [Protocol HR1-2-3], Middle Risk ALL [Protocol M, Mtx 5gr / m2] The patient does not have any other chronic disease
  • The patient does not have a systemic infection
  • The patient has a central venous catheter or port catheter Volunteering of the mother and the caregiver parent
  • The caring parent knows Turkish and is open to communication

排除标准

  • 未提供

结局指标

主要结局

change of the degree of mucositis

时间窗: through study completion, an average of 2 weeks

the change in the child's mucositis by using WHO Mucositis Scale

change of pain level due to mucositis with Numeric Pain Scale

时间窗: through study completion, an average of 2 weeks

It is the form that includes the pain assessment scale suitable for the child's age. The Numerical Pain Scale for children aged 7 and above.

Change of Mucositis knowledge scores of caregivers

时间窗: change from baseline to three days after training

It is the form prepared by the researchers in line with the literature, questioning the parents' knowledge of the definition of oral/anal mucositis and the application of care principles in mucositis.

change of weight

时间窗: change from baseline to seven days after training

change in the child's body weight

Change of Pediatric Oral / Anal Mucositis Care Skills

时间窗: change from baseline to three days after training

It is a form prepared by researchers in line with the literature in which the skills of parents regarding the application of care principles in oral / anal mucositis are questioned.

change of pain level due to mucositis with WB Scale

时间窗: through study completion, an average of 2 weeks

It is the form that includes the pain assessment scale suitable for the child's age. The Wong-Baker Facial Pain Scale will be used for children aged 2 months to 6 years

Change of Mucosal barrier injury laboratory-confirmed bloodstream infection rate

时间窗: change from baseline to seven days after training

It is a test to eveluate mucosal barrier injury laboratory-confirmed bloodstream infection rate

oral mucositis area measurement

时间窗: change from baseline to seven days after 21 days

The measurement will be evaluated with IMITO Wound Application

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

SEDA ARDAHAN SEVGİLİ

Research Assistant

Ege University

研究点 (1)

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