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

Sponsor
Ege University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04813783
Collaborator
(none)
52
1
32
1.6

Study Details

Study Description

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".

Condition or Disease Intervention/Treatment Phase
  • Other: Mucositis care training to be given in line with MASCC / ISOO 2019

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 Design

Study Type:
Observational
Anticipated Enrollment :
52 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effect of Mucositis Care Training Given to Caregivers in Pediatric Leukemia Cases on Mucosal Barrier Damage
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Change of Mucositis knowledge scores of caregivers [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 [change from baseline to seven days after training]

    change in the child's body weight

  3. change of the degree of mucositis [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 [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 [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 [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 [change from baseline to seven days after training]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 18 Years
Sexes Eligible for Study:
All
Accepts 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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ege University Hospital İzmir Turkey

Sponsors and Collaborators

  • Ege University

Investigators

  • Study Chair: SELMİN ŞENOL, KÜTAHYA UNIVERSITY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SEDA ARDAHAN SEVGİLİ, Research Assistant, Ege University
ClinicalTrials.gov Identifier:
NCT04813783
Other Study ID Numbers:
  • 20-6.1T/62
First Posted:
Mar 24, 2021
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2021