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Completed

NCT Number: NCT04813783

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

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".

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Key information

Conditions

Leukemia Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Mouth Diseases Mucositis Neoplasms Neoplasms by Histologic Type Nursing Care Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Stomatognathic Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ege University Hospital

Izmir, Turkey (Türkiye)

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

Other

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

Primary outcomes

  1. Change of Mucositis knowledge scores of caregivers

    Time frame: 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.

  2. change of weight

    Time frame: change from baseline to seven days after training

    change in the child's body weight

  3. change of the degree of mucositis

    Time frame: through study completion, an average of 2 weeks

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

  4. change of pain level due to mucositis with WB Scale

    Time frame: 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

  5. change of pain level due to mucositis with Numeric Pain Scale

    Time frame: 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.

  6. Change of Pediatric Oral / Anal Mucositis Care Skills

    Time frame: 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.

  7. Change of Mucosal barrier injury laboratory-confirmed bloodstream infection rate

    Time frame: change from baseline to seven days after training

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

  8. oral mucositis area measurement

    Time frame: change from baseline to seven days after 21 days

    The measurement will be evaluated with IMITO Wound Application

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2021
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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