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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04813783
Enrollment
52
Registered
2021-03-24
Start date
2021-05-01
Completion date
2022-12-31
Last updated
2023-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Mucositis, Nursing Care, Pediatric ALL

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.

Interventions

OTHERMucositis care training to be given in line with MASCC / ISOO 2019

Mucositis care training to be given in line with MASCC / ISOO 2019

Sponsors

Ege University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Change of Mucositis knowledge scores of caregiverschange from baseline to three days after trainingIt 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 weightchange from baseline to seven days after trainingchange in the child's body weight
change of the degree of mucositisthrough study completion, an average of 2 weeksthe change in the child's mucositis by using WHO Mucositis Scale
change of pain level due to mucositis with WB Scalethrough study completion, an average of 2 weeksIt 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 pain level due to mucositis with Numeric Pain Scalethrough study completion, an average of 2 weeksIt 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 Pediatric Oral / Anal Mucositis Care Skillschange from baseline to three days after trainingIt 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 Mucosal barrier injury laboratory-confirmed bloodstream infection ratechange from baseline to seven days after trainingIt is a test to eveluate mucosal barrier injury laboratory-confirmed bloodstream infection rate
oral mucositis area measurementchange from baseline to seven days after 21 daysThe measurement will be evaluated with IMITO Wound Application

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026