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CTRI Number  CTRI/2024/09/073202 [Registered on: 02/09/2024] Trial Registered Prospectively
Last Modified On: 01/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Spectrum of physical and mental health in children living in orphanage, descriptive study 
Scientific Title of Study   Physical, Emotional and Behavioural well being among children living in orphanages in Bengaluru Urban, A Cross Sectional Descriptive study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kruthi M 
Designation  Paediatric Post Graduate 
Affiliation  BGS Global Institute of Medical Sciences  
Address  Department of Paediatrics,BGS Global Institute of Medical Sciences, Kengeri,Bengaluru-560060
NO.60, 19th C CROSS, 7th main, BTM Layout 2nd stage, Bengaluru
Bangalore
KARNATAKA
560076
India 
Phone  9741322931  
Fax    
Email  kruthidev12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Ramesh M 
Designation  Professor and Head of Department 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of Paediatrics,BGS Global Institute of Medical Sciences, Kengeri,Bengaluru
BGS Global Institute of Medical Sciences, Kengeri , Bengaluru
Bangalore
KARNATAKA
560060
India 
Phone  9900111261  
Fax    
Email  rameshmalliah@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kruthi M 
Designation  Post graduate student 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of Paediatrics,BGS Global Institute of Medical Sciences, Kengeri,Bengaluru-560060
BGS Global Institute of Medical Sciences, Kengeri , Bengaluru-560060
Bangalore
KARNATAKA
560060
India 
Phone  9741322931  
Fax    
Email  kruthidev12@gmail.com  
 
Source of Monetary or Material Support  
BGS Global Institute of Medical Sciences, Kengeri, Bengaluru-560060 
 
Primary Sponsor  
Name  Dr Kruthi M 
Address  BGS Global Institute of Medical Sciences, Kengeri, Bengaluru-560060 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kruthi M  BGS Global Institute of Medical Sciences  Department of Paediatrics, Kengeri, Bengaluru-560060
Bangalore
KARNATAKA 
9741322931

kruthidev12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BGS Global Institute of Medical Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  children living in orphanages 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1)Children in age group 4-18 years residing in orphanages in Bengaluru urban.
2)Informed consent obtained from Legal guardian.
 
 
ExclusionCriteria 
Details  informed consent not obtained 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To assess anthropometry of children in Orphanage
2.To study the prevalence and the types of behavioral and emotional problems in children living in orphanages.
 
1 year  
 
Secondary Outcome  
Outcome  TimePoints 
To determine signs of nutritional deficiency among the study group by clinical assessment  1 year 
 
Target Sample Size   Total Sample Size="167"
Sample Size from India="167" 
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)   16/09/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

United Nations International Children’s Emergency Fund quotes A child as every human being below the age of eighteen years unless under the law applicable to the child, majority is attained earlier

Protecting and improving the health of children is of fundamental importance. A great deal of work remains to improve the health outcomes for children. More than half of child deaths are due to conditions that could be easily prevented or treated given access to health care and improvements to their quality of life.

At the same time, children must also be given a stable environment in which to thrive, including good health and nutrition, protection from threats and access to opportunities to learn and grow. Investing in children is one of the most important things a society can do to build a better future.

The most accepted definition of orphan is “A child who has lost both parents through bereavement. However this definition is often extended to include loss of parents through desertion or abandonment where the parents are unable or unwillling to provide for the child”.

An Orphanage is a residential institution for taking care of and educating orphans. Children living In orphanages are socially vulnerable group often neglected by mainstream society and are more prone to malnutrition and psycho social stress .

Children and adolescents who are orphans, runaways, or abandoned by families and bring reared in institutional homes form vulnerable group according to the Integrated Child Protection Scheme, India as they would have gone through repeated neglect, abuse or fear.

Child under nutrition is a major public health problem, Anthropometric analysis is an effective tool for assessment of nutritional status, growth and development of children. Decision making and planning in child health nutrition should be based on updated growth charts.

Mental health comprises of ones’s own feelings, cognitive process and enlightenment. It affects our thinking, feeling , life processes and also effects our stress handling skills. Mental health is very important at every stage of life .

 Many factors such as biological, brain chemistry, genes, life experiences such as trauma or abuse and family history of mental health are causes of mental health problems. According to the World Health Organization when children do not achieve social and behavioural potential then they lose their confidence and suffer from many mental health issues .

 Mental health play important role in Adolescent life. In this period adolescents feel lots of changes in their life. When they enter social life, they feel lots of changes and face many issues. Social problems like delinquency, crime, suicide, alcoholism, drug addiction, prejudice, underachievement and dropping out of school are more sensitive problems in adolescent.

WHO says that worldwide 10-20% of adolescents experience mental health half of all mental illnesses begin in the age of 14 and two -quarters by mid 20s. Therefore, Adolescents face major challenges like stigma, isolation and discrimination, as well as lack of access to health care and education facilities. Detection of early signs of disturbed mental health and time appropriate intervention will decrease morbidity and mortality  
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