The Effect of Nursing Care Bundle on Oral Intake Among Critically Ill Children With Post-Extubation Dysphagia: Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline of oral health post-extubation on Post-Extubation Oral Assessment Scale
研究概览
简要总结
the aim of this study is to evaluate the effect of Nursing care Bundle on Oral Intake among Critically Ill Children with Post-Extubation Dysphagia
详细描述
The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the children provided an informed consent. children's baseline data was collected from their records prior to intervention in order to identify children who meet the required criteria of the study. then the participants were selected and divided randomly (using a simple random method) into two equal groups. One subject for the control group, one for the study group, and so on, distributed the participants into two equivalent groups as fellow:
Control Group: Consisted of 30 children who will receive conventional hospital care with no additional interventions.
Study Group: Consisted of 30 children who will receive a nursing care bundle on oral intake starting the day after their successful extubation and extend for 14th days. Additionally, the participants were provided with a brief education on safe swallowing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing emergency oral endotracheal intubation for at least 48 hours
- •able to communicate and having no sensory deficit and accepted to participate in the research
排除标准
- •children who had a history of neuromuscular disease, preexisting swallowing problems and agitated children were excluded.
研究组 & 干预措施
Conventional care group
Consisted of 30 children who will receive conventional hospital care with no additional interventions.
Care bundle group
Consisted of 30 children who will receive a nursing care bundle for enhancing oral intake
干预措施: a nursing care bundle on oral intake (Procedure)
结局指标
主要结局
Change from baseline of oral health post-extubation on Post-Extubation Oral Assessment Scale
时间窗: The first measurement time will be From extubation of mechanical ventilation up to 1 week"7 th day's post-extubation". The second time will be from extubation up to 2 week"14th day's" post-extubation
It consisted of eight categories including Voice, ability to swallow, lips, saliva, tongue, mucous membranes, gingiva and teeth. scoring of each component 0 score indicates (normal) , 1 score indicates (mild abnormality) and 2 scores indicate (sever abnormality). Total score (0-3) indicates minimal risk of post-extubation complications ,4-6 indicates moderate risk of complications and 7-10 indicates high risk of post-extubation complications.
change from the baseline in swallowing on Pediatric Dysphagia Screening Questionnaire (PDSQ)
时间窗: The first measurement time will be From extubation of mechanical ventilation up to 1 week"7 th day's post-extubation". The second time will be from extubation up to 2 week"14th day's" post-extubation
it designed to identify children at risk for oropharyngeal dysphagia. scoring of each component 0 score indicates (no difficultly) ,1 score indicates (mild difficulty)2 scores (moderate difficulty) and 3 score indicates (severe difficulty). Total score (0-5) indicates minimal or to no dysphagia risk ,6-10 indicates to some dysphagia risk, 11-15 indicates high dysphagia risk and 16-18 indicates Severe dysphagia risk.
change from baseline of normal oral intake of the children on the Pediatric Functional Oral Intake Scale (P-FOIS)
时间窗: The first measurement time will be From extubation of mechanical ventilation up to 1 week"7 th day's post-extubation". The second time will be from extubation up to 2 week"14th day's" post-extubation
it includes a 6-point scale used to assess a child's oral intake ability. It categorizes intake into seven levels, ranging from complete dependence on non-oral feeding to successful oral intake.
次要结局
未报告次要终点
研究者
Eman Wardany Abdelaal Mohamed
assistant professor of pediatric nursing
Kafrelsheikh University