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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Leukemia, Mucositis, Nursing Care, Pediatric ALL

Intervention / Treatment
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* Other: Mucositis care training to be given in line with MASCC / ISOO 2019


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>The first group of 26 volunteers who meet the inclusion criteria of the study will form the control group. These participants will be given clinical routine training about mucositis care. | |
| Intervention Group<br>In the study, in order to prevent/minimize the flow of information between the control and intervention groups, the data of the control group will be collected first. Data collection will be suspended in the clinic for three months after the control group data is completed. After this period, data of the enterprise group will be collected. Participants in the intervention group will be provided with mucositis training within the scope of the Mucositis Care Protocol in line with the MASCC / ISOO 2019 Recommendations. | Other: Mucositis care training to be given in line with MASCC / ISOO 2019<br>* Mucositis care training to be given in line with MASCC / ISOO 2019<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Mucositis knowledge scores of caregivers | 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 from baseline to three days after training | 
| change of weight | change in the child's body weight | change from baseline to seven days after training | 
| change of the degree of mucositis | the change in the child's mucositis by using WHO Mucositis Scale | through study completion, an average of 2 weeks | 
| change of pain level due to mucositis with WB Scale | 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 | through study completion, an average of 2 weeks | 
| change of pain level due to mucositis with Numeric Pain Scale | 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. | through study completion, an average of 2 weeks | 
| Change of Pediatric Oral / Anal Mucositis Care Skills | 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 from baseline to three days after training | 
| Change of Mucosal barrier injury laboratory-confirmed bloodstream infection rate | It is a test to eveluate mucosal barrier injury laboratory-confirmed bloodstream infection rate | change from baseline to seven days after training | 
| oral mucositis area measurement | The measurement will be evaluated with IMITO Wound Application | change from baseline to seven days after 21 days |