| CTRI Number |
CTRI/2024/06/068279 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Phenomenological study |
| Study Design |
Other |
|
Public Title of Study
|
To understand the experiences, challanges and how parents deal with their children having MPS disease. |
|
Scientific Title of Study
|
A Phenomenological study to explore the lived in experiences, challenges and coping strategies faced by parents of children wiith Mucoploysaccharidiosis(MPS). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Jakhar |
| Designation |
Msc Nursing student (Paediatric) |
| Affiliation |
All india institute of medical sciences Delhi |
| Address |
Porta cabin-2, College of Nursing, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
9717134821 |
| Fax |
|
| Email |
jrneha456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yumnam Surbala Devi |
| Designation |
Associate professor |
| Affiliation |
All India Institute of medical sciences New Delhi |
| Address |
2nd floor, room no. 2, College of Nursing, All India Institute of Medical Sciences, Ansari Nagar, south West, New Delhi 110029
South
DELHI
110029
India |
| Phone |
9953559853 |
| Fax |
|
| Email |
surshaikhom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yumnam Surbala Devi |
| Designation |
Associate professor |
| Affiliation |
All India Institute of medical sciences New Delhi |
| Address |
2nd floor, room no. 2, College of Nursing, All India Institute of Medical Sciences, Anssari Nagar, New Delhi 110029
South
DELHI
110029
India |
| Phone |
9953559853 |
| Fax |
|
| Email |
surshaikhom@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences New Delhi |
|
|
Primary Sponsor
|
| Name |
Neha Jakhar |
| Address |
Porta cabin 2 , college of nursing , All India institute Of Medical Sciences , Ansari Nagar , South West , New Delhi - 110029
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Yumnam Surbala Devi |
Pediatric OPD , 2nd floor ,RAK Block , AIIMS Delhi |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
South
DELHI |
9953559853
surshaikhom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee for Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents of children with Mucopolysaccharidosis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Either Mother or Father of children age between 2 to 14 yrs diagnosed with Mucopolysaccharidosis stage I II IV VI VII IX
Those who are able to communicate through english or hindi |
|
| ExclusionCriteria |
| Details |
Not able to participate
those with type III disease |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To understand and interpret parents experience of living and caring for a children with MPS.
2 To explore the challenges faced by parents of children with MPS.
|
During study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Coping strategies faced by parents |
During study |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/08/2024 |
| 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="0"
Months="6"
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
|
A phenomnological study to explore the lived in experiences challenges and coping stratergies faced by parents of children with mucopolysacchridosis the need of the study arrises because mucopolysacchridosis is a very rare inherited metabolic disorder which has profound effect on the lives of the family and the children |