| 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
|
|
|
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
|
|
|
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 childâ€. 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 |