Oral Mucositis Management Supported by MASCC/ISOO Protocols: A Randomized Controlled Trial in Pediatric Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- CHIMES scores
研究概览
简要总结
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.
详细描述
Data Collection Process The researchers informed children and their parents about the purpose of the study. Written and verbal consent was obtained from both willing children and their parents.
The researcher works as a nurse in the pediatric oncology clinic. If the children met the inclusion criteria, the researchers visited the clinics, introduced themselves to the child and the family, and provided information about the research. The child and the family were informed about the research. All caregivers (both intervention and control groups) who meet the inclusion criteria and agree to participate in the study will be asked to fill out the Descriptive Characteristics Form. Research data will be obtained by conducting four assessment interviews with each child and caregiver. The first interview will be conducted before the treatment, the second interview will be conducted on the 3rd day after the treatment, and the following interviews will be conducted on the 7th and 14th days of the treatment and the oral mucosa will be evaluated by the researcher by interviewing the child and caregiver and using scales.
The child and caregiver in the intervention group will receive an oral care protocol on days 0-14 of treatment. The child and caregiver in the control group will receive standard care.
Procedures Intervention Group 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 18 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Conditions that prevent verbal communication (neurodevelopmental delay, verbal speech difficulties, hearing or hearing problems; oral mucositis).
结局指标
主要结局
CHIMES scores
时间窗: day14
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
WHO Oral Mucositis Granding Scale
时间窗: day14
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
次要结局
未报告次要终点
研究者
Zubeyde Ezgi Ercelik
Assistant Professor
Bandırma Onyedi Eylül University