| CTRI Number |
CTRI/2025/03/081709 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Education, counselling and reinforcement] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of nursing care on the well being of children with hypertension |
|
Scientific Title of Study
|
Effectiveness of nursing intervention package on the biophysiological variables, behavioural patterns and quality of life among CKD Children with hypertension at AIIMS, New Delhi |
| Trial Acronym |
Holistic well being |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Cecilia MS |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No.6
College of Nursing,
Old OT block
AIIMS, New Delhi
No. 208,
Faculty transit Accomodation
Ayurvigyan Nagar
Delhi 110049
South
DELHI
110029
India |
| Phone |
9899187056 |
| Fax |
|
| Email |
cecilia.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Cecilia MS |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 6
College of Nursing,
Old OT block
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9899187056 |
| Fax |
|
| Email |
cecilia.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Cecilia MS |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No.6
College of Nursing,
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9899187056 |
| Fax |
|
| Email |
cecilia.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| New RAK OPD
AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
Cecilia Mary Susaimuthu |
| Address |
Room No. 6
College of Nursing
AIIMS, New Delhi |
| Type of Sponsor |
Other [Researcher] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Cecilia Mary Susaimuthu |
AIIMS, New Delhi |
MCH Block, RAK OPD, AIIMS, New Delhi
South
DELHI |
09899187056
cecilia.aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z518||Encounter for other specified aftercare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nursing intervention for approximately 45 minutes |
Patient along with caregiver will recieve one to one couselling related to diet, physical exercise and importance of compliance to prescribed drugs. Weekly reminders will be sent to them through whatsapp regarding the same. |
| Comparator Agent |
Routine care |
Patients will receive routine care from the hospital |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
The study excludes CKD children with hypertension who are
Mentally or physically challenged
Having congenital anomaly
Unable to follow instructions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To develop and validate nursing intervention package on holistic wellbeing among children with hypertension.
2. To assess the effectiveness of nursing intervention package on holistic wellbeing ( Biophysiological variables) among children with hypertension.
|
At baseline and after 12 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3. To assess the diet adherence among children with hypertension.
4. To assess the drug compliance among children with hypertension.
5. To assess the level of satisfaction regarding Nursing intervention package among caregivers and children with hypertension.
6. To determine the association between demographic variables and various parameters of holistic well-being among children with hypertension.
|
after 12 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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.
|