Clinical trial NCT04813783: The Effect of Mucositis Care Training Given to Caregivers in Pediatric Leukemia Cases on Mucosal Barrier Damage
Official title: The Effect of Mucositis Care Training Given to Caregivers in Pediatric Leukemia Cases on Mucosal Barrier Damage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Mucositis
Nursing Care
Pediatric ALL
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 52
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the study will be the cases in the 2-18 age group followed in the Ege University Faculty of Medicine Children's Hospital Pediatric Hematology Clinic and their primary caregiver parents.

Brief summary: 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: 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".

Eligibility criteria: 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:

-

Primary outcomes:
measure: Change of Mucositis knowledge scores of caregivers
timeFrame: change from baseline to three days after training
measure: change of weight
timeFrame: change from baseline to seven days after training
measure: change of the degree of mucositis
timeFrame: through study completion, an average of 2 weeks
measure: change of pain level due to mucositis with WB Scale
timeFrame: through study completion, an average of 2 weeks
measure: change of pain level due to mucositis with Numeric Pain Scale
timeFrame: through study completion, an average of 2 weeks
measure: Change of Pediatric Oral / Anal Mucositis Care Skills
timeFrame: change from baseline to three days after training
measure: Change of Mucosal barrier injury laboratory-confirmed bloodstream infection rate
timeFrame: change from baseline to seven days after training
measure: oral mucositis area measurement
timeFrame: change from baseline to seven days after 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Hospital
Study officials:
affiliation: KÜTAHYA UNIVERSITY
name: SELMİN ŞENOL
role: STUDY_CHAIR
References: