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

NCT04813783 | Completed DMC

• 1 other identifier: 20-6.1T/62
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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".

Conditions

Leukemia; Mucositis; Nursing Care; Pediatric ALL

Outcome Measures

Primary Outcomes (8)

• 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

• change of weight

  change in the child's body weight

  change from baseline to seven days after training

• 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

• 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

• 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

• 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

• 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

• oral mucositis area measurement

  The measurement will be evaluated with IMITO Wound Application

  change from baseline to seven days after 21 days

Study Arms (2)

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

Interventions

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

Intervention Group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Leukemia; Mucositis; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• SELMİN ŞENOL

  KÜTAHYA UNIVERSITY

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 24, 2021
• Study Start: May 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 31, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)