跳至主要内容
临床试验/CTRI/2024/12/078685
CTRI/2024/12/078685尚未招募4 期

A Study to Develop Evidence Informed Oral Care Guidelines for Indian Context and Find its Effectiveness on Oral Health Status of Children with Cancer Receiving Chemotherapy

Manipal College of Nursing, Manipal Academy of Higher Education1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
Oral health status of children

研究概览

简要总结

This study aims to develop and evaluate evidence-based oral care guidelines tailored for children with cancer to prevent and manage oral complications during treatment. The study involves observing current practices, engaging stakeholders via focus group discussions, and implementing interventions including training and education of nursing staff and parents of children with cancer, and the use of specifically curated oral care kits for such children. The guidelines will be pretested for feasibility and finalized before assessing their effectiveness in improving oral health outcomes among pediatric cancer patients.

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
5.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children aged 5 to 18 years, whose parents give consent to participate in the study.
  • Parents who are able to read and understand Kannada or English.
  • Children in the ‘induction’ phase of chemotherapy or receiving Neoadjuvant Chemotherapy (NACT) Children receiving chemotherapy, radiation therapy, or a combination of both.

排除标准

  • Children with cancer on best supportive care.
  • Children with severe oral health conditions unrelated to cancer such as severe periodontal disease, congenital oral malformations.

结局指标

主要结局

Oral health status of children

时间窗: 2-3 assessments during in-patient stay, twice-monthly assessments during next 6 months of follow up

Oral care practices followed by caregivers and children

时间窗: 2-3 assessments during in-patient stay, twice-monthly assessments during next 6 months of follow up

次要结局

  • Knowledge level of parents and staff nurses on oral care practices(2-3 assessments during in-patient stay, twice-monthly assessments during next 6 months of follow up)

研究者

发起方
Manipal College of Nursing, Manipal Academy of Higher Education
申办方类型
Other [Private Nursing College]
责任方
Principal Investigator
主要研究者

Meghna Pandit

Manipal College of Nursing, MAHE, Manipal

研究点 (1)

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