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临床试验/CTRI/2025/03/081709
CTRI/2025/03/081709尚未招募不适用

Effectiveness of nursing intervention package on the biophysiological variables, behavioural patterns and quality of life among CKD Children with hypertension at AIIMS, New Delhi

Cecilia Mary Susaimuthu1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
1. To develop and validate nursing intervention package on holistic wellbeing among children with hypertension.

研究概览

简要总结

Chronic kidney disease (CKD) is quickly becoming a global epidemic. (14) Chronic kidney disease affects more than 10 percent of the population accounting to more than 800 million people worldwide. It is a huge burden in low- and middle-income countries and a leading cause of mortality worldwide. CKD is one of the noncommunicable diseases that has shown increase in associated deaths in the past 20 years. (5)  CKD is projected to be 5th most common cause of years of life lost globally. (10)

Globally individuals with acute kidney injury, chronic kidney disease and those on renal replacement therapy has exceeded 850 million. Hence kidney diseases are one of the most common diseases worldwide (11)

KDIGO guidelines 2024 recommends children with CKD should be provided lifestyle counselling. Increasing physical activity, changes in diet and weight management and appropriate treatment strategies will reduce the risk of progression of disease and comorbidities (9)

Hence the researcher intends to provide nursing intervention that includes education regarding increase in physical activity, dietary changes as per the need of the child and regular monitoring of blood pressure and the influence of these lifestyle factors on the biophysiological variable namely blood pressure, lipid profile, HbA1c and urine sodium levels, fatigue, sleep and quality of life.

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

入选标准

  • CKD Children diagnosed with hypertension, who are Aged between 8 to 18 years Able to perform physical activity Able to read and write Hindi/English Willing to participate in the study.

排除标准

  • The study excludes CKD children with hypertension who are Mentally or physically challenged Having congenital anomaly Unable to follow instructions.

结局指标

主要结局

1. To develop and validate nursing intervention package on holistic wellbeing among children with hypertension.

时间窗: At baseline and after 12 weeks of intervention

2. To assess the effectiveness of nursing intervention package on holistic wellbeing ( Biophysiological variables) among children with hypertension.

时间窗: At baseline and after 12 weeks of intervention

次要结局

  • 3. To assess the diet adherence among children with hypertension.(4. To assess the drug compliance among children with hypertension.)

研究者

发起方
Cecilia Mary Susaimuthu
申办方类型
Other [researcher]
责任方
Principal Investigator
主要研究者

Cecilia MS

AIIMS, New Delhi

研究点 (1)

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