Oral Mucositis Management in Pediatric Oncology Patients

NCT06711315 | Completed

• 2 other identifiers: 2023 - 695From Researcher
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the impact of an oral mucositis care protocol on the severity of mucositis. The main questions it aims to answer are:

• What is the severity of mucositis in parents and children who receive oral mucositis education? The data were collected using a descriptive information form, the Children's International Mucositis Evaluation Scale (ChIMES), and the WHO Oral Mucositis Grading Scale. Standard care was applied to the control group. For the intervention group, an oral care protocol was prepared, and the patients received training. The oral care intervention was applied for 14 days and monitored by the researcher. The patients were monitored for oral mucositis on Days 0, 3, 7, and 14. Those in the intervention group received a calendar for documenting their oral care practices.

Conditions

Childhood Oncology; Mucositis Oral

Keywords

Childhood, cancer, oral mucosit, oral care

Outcome Measures

Primary Outcomes (8)

• CHIMES scores

  The scale consists of categories such as the severity of pain in the mouth, the effect of pain on swallowing, eating, drinking, taking painkillers, and the presence of ulcers in the mouth.The lowest score obtained from the scale is 0, the highest score is 23. The higher the total score, the more advanced the degree of mucositis

  day0

• CHIMES scores

  The scale consists of categories such as the severity of pain in the mouth, the effect of pain on swallowing, eating, drinking, taking painkillers, and the presence of ulcers in the mouth.The lowest score obtained from the scale is 0, the highest score is 23. The higher the total score, the more advanced the degree of mucositis

  day3

• CHIMES scores

  The scale consists of categories such as the severity of pain in the mouth, the effect of pain on swallowing, eating, drinking, taking painkillers, and the presence of ulcers in the mouth.The lowest score obtained from the scale is 0, the highest score is 23. The higher the total score, the more advanced the degree of mucositis

  day7

• CHIMES scores

  The scale consists of categories such as the severity of pain in the mouth, the effect of pain on swallowing, eating, drinking, taking painkillers, and the presence of ulcers in the mouth.The lowest score obtained from the scale is 0, the highest score is 23. The higher the total score, the more advanced the degree of mucositis

  day14

• WHO Oral Mucositis Granding Scale

  The presence of oral mucositis is assessed based on clinical manifestations. The score ranges from 0 (the absence of manifestations and symptoms) to 4 (oral feeding is impossible). Grade-0 no change in mucosa, Grade-1 painless ulcers, erythema or mild sensitization, Grade-2 painful erythema and ulcer but can consume solid foods. Grade-3 painful erythema, edema or ulcer can consume only fluids, Grade-4 ulceration, necrosis and hemorrhage, patient cannot feed, enteral or parenteral support is required

  day0

• WHO Oral Mucositis Granding Scale

  The presence of oral mucositis is assessed based on clinical manifestations. The score ranges from 0 (the absence of manifestations and symptoms) to 4 (oral feeding is impossible). Grade-0 no change in mucosa, Grade-1 painless ulcers, erythema or mild sensitization, Grade-2 painful erythema and ulcer but can consume solid foods. Grade-3 painful erythema, edema or ulcer can consume only fluids, Grade-4 ulceration, necrosis and hemorrhage, patient cannot feed, enteral or parenteral support is required

  day3

• WHO Oral Mucositis Granding Scale

  The presence of oral mucositis is assessed based on clinical manifestations. The score ranges from 0 (the absence of manifestations and symptoms) to 4 (oral feeding is impossible). Grade-0 no change in mucosa, Grade-1 painless ulcers, erythema or mild sensitization, Grade-2 painful erythema and ulcer but can consume solid foods. Grade-3 painful erythema, edema or ulcer can consume only fluids, Grade-4 ulceration, necrosis and hemorrhage, patient cannot feed, enteral or parenteral support is required

  day7

• WHO Oral Mucositis Granding Scale

  The presence of oral mucositis is assessed based on clinical manifestations. The score ranges from 0 (the absence of manifestations and symptoms) to 4 (oral feeding is impossible). Grade-0 no change in mucosa, Grade-1 painless ulcers, erythema or mild sensitization, Grade-2 painful erythema and ulcer but can consume solid foods. Grade-3 painful erythema, edema or ulcer can consume only fluids, Grade-4 ulceration, necrosis and hemorrhage, patient cannot feed, enteral or parenteral support is required

  day14

Study Arms (2)

Intervention Group

EXPERIMENTAL

Oral mucositis education was given, oral care was requested for 14 days and monitored on days 0, 3, 7 and 14.

Behavioral: Oral Mucosit Care Protocol

Control Group

NO INTERVENTION

Children in the control group will receive standard care. Mouthwash with sodium bicarbonate (after each feeding), mycostatin (2x1) and tranflex (3x1). Toothbrush and dental floss are not used. At the end of the 14th day, the child and caregiver in the control group will receive Oral Care Protocol Training to Prevent Oral Mucositis.

Interventions

Oral Mucosit Care Protocol BEHAVIORAL

The children in the intervention group were subjected to a four-stage intervention carried out by the nurse researcher. The practices in each stage were as follows. Stage 1: Oral care protocol training to prevent oral mucositis Stage 2: Introduction and application of training material (brochure) Stage 3: Introduction and implementation of oral care calendar Stage 4: Implementation of oral care protocol

Intervention Group

Eligibility Criteria

• Age: 6 Weeks - 18 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being between 6 and 18 years,
• Having received at least 1 course of chemotherapy,
• Having no visual, auditory, or intellectual problems
• Speaking and understanding Turkish
• Being willing to participate in the research.

You may not qualify if:

• Conditions that prevent verbal communication (neurodevelopmental delay, verbal speech difficulties, hearing or hearing problems; oral mucositis).

Sponsors & Collaborators

• Zubeyde Ezgi Ercelik: lead

Study Sites (1)

Zonguldak Bülent Ecevit University Training and Research Hospital

Zonguldak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stomatitis; Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: June 1, 2023
• Primary Completion: August 6, 2024
• Study Completion: September 1, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)