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

February 8, 2023 updated by: SEDA ARDAHAN SEVGİLİ, Ege University

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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".

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey
        • Ege University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
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
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
Mucositis care training to be given in line with MASCC / ISOO 2019

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline to three days after training
change of weight
Time Frame: change from baseline to seven days after training
change in the child's body weight
change from baseline to seven days after training
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
through study completion, an average of 2 weeks
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
through study completion, an average of 2 weeks
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.
through study completion, an average of 2 weeks
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.
change from baseline to three days after training
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
change from baseline to seven days after training
oral mucositis area measurement
Time Frame: change from baseline to seven days after 21 days
The measurement will be evaluated with IMITO Wound Application
change from baseline to seven days after 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Study Chair: SELMİN ŞENOL, KÜTAHYA UNIVERSITY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2021

Primary Completion (ACTUAL)

October 1, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

March 20, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (ACTUAL)

March 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-6.1T/62

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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