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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04813783
• Other study ID #: 20-6.1T/62
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 31, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Leukemia
• Mucositis
• Nursing Care
• Pediatric ALL

Intervention

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

Locations

Country	Name	City	State
Turkey	Ege University Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	change of weight	change in the child's body weight	change from baseline to seven days after training
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	oral mucositis area measurement	The measurement will be evaluated with IMITO Wound Application	change from baseline to seven days after 21 days