Development and Implementation of an Evidence-Based Oral Care Bundle to Reduce the incidence and severity of Oral Mucositis among children with cancer Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reduce the incidence and severity of Oral Mucositis among children Receiving Chemotherapy
研究概览
简要总结
Oral mucositis (OM) is a frequent and debilitating complication of chemotherapy in pediatric oncology patients, leading to pain, poor nutrition, infection risk, and treatment interruptions. Current oral care practices are inconsistent and lack standardization. This study aims to develop, validate, and implement an evidence-based oral care bundle, incorporating daily oral hygiene, cryotherapy, topical agents (fluoride toothpaste, lanolin-based lip balm, honey), and caregiver/nurse education.
The project will be conducted in a single-arm design at a tertiary pediatric oncology center. Eligible children initiating chemotherapy will be followed from Day 1 up to Day 14 for the development and severity of OM, assessed using CTCAE v5 criteria during each nursing shift. Compliance checklists for nurses and caregivers will be used to monitor adherence.
This project is expected to standardize oral care practices, reduce the burden of OM, improve treatment tolerance, and enhance the quality of life of children undergoing chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 1 to 14 years diagnosed with cancer.
- •Children receiving chemotherapy agents known to carry a high risk of causing oral mucositis as inpatients.
- •Children who can be monitored for mucositis for up to 14 days after receiving chemotherapy.
- •Parents or caregivers who give informed consent.
排除标准
- ••Children with congenital anomalies or other severe comorbidities that may interfere with oral care assessments.
- ••Children who have initiated their chemotherapy regimen in other units or hospitals, outside the study setting.
结局指标
主要结局
Reduce the incidence and severity of Oral Mucositis among children Receiving Chemotherapy
时间窗: Day 1 to day 14 of chemotherapy
次要结局
- Change in nursing knowledge score (pre-test,post-test)(Immediately pre-training and immediately post-training)
- percentage of children maintaining adequate oral intake during 1–14 Days of chemo(post-implementation (Day 1–14 of chemo cycles))
- Caregiver satisfaction score(Post-implementation - during discharge)
- Caregiver adherence rate to bundle tasks(Daily during hospitalization)
- Nurse satisfaction score with bundle implementation(At 1 month post-implementation (and optionally at 3 and 6 months))
- Nurse adherence rate to bundle(Weekly during implementation period)
研究者
Anjana G N
Malabar Cancer Centre - Post Graduate Institute of Oncology Sciences and Research