| CTRI Number |
CTRI/2024/07/070876 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed Method |
| Study Design |
Other |
|
Public Title of Study
|
Assess the lived experiences and quality of life of children with urinary incontinence and their caregivers |
|
Scientific Title of Study
|
A convergent parallel mixed method study on lived experiences and quality of life of children with urinary incontinence and their caregivers attending OPD, APC, PGIMER, Chandigarh 2023-25 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roselin |
| Designation |
MSc Nursing Student |
| Affiliation |
National Institute of Nursing Education PGIMER Chandigarh |
| Address |
National institute of nursing education Post-Graduate Institue of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7638945337 |
| Fax |
|
| Email |
roselindhar2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. Meenakshi Agnihotri |
| Designation |
Tutor |
| Affiliation |
National institute of nursing education PGIMER Chandigarh |
| Address |
Room No.207 National institute of nursing education Post-Graduate Institue of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872885336 |
| Fax |
|
| Email |
smrishima@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Roselin |
| Designation |
MSc Nursing Student |
| Affiliation |
National institute of nursing education |
| Address |
Room No. 207 National institute of nursing education Post-Graduate Institue of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7638945337 |
| Fax |
|
| Email |
roselindhar2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Advance Pediatric center,Post-Graduate Institue of Medical Education and Research, Chandigarh - 160012 |
|
|
Primary Sponsor
|
| Name |
Roselin Dhar |
| Address |
Post-Graduate Institue of Medical Education and Research, Chandigarh - 160012 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Not Any |
Not Any |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Roselin Dhar |
Postgraduate Institue of Medical Education and Research, Chandigarh |
Room Number 3415, fourth floor, Block D, Advance Pediatric Centre
Chandigarh
CHANDIGARH |
7638945337
roselindhar2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N328||Other specified disorders of bladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with urinary incontinence aged 6 to 12 year and their care givers who are able to speak Hindi or English and who are willing to give consent and participate in the study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of my study is Quality of life, lived experiences of children and their caregivers |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the quality of life of children with urinary incontinence & their caregivers for further duration of periods |
6 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
30/07/2024 |
| 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="3"
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
|
The study aims to address the pressing issue of urinary incontinence among children, a significant health concern impacting both children and their caregivers. Urinary incontinence, whether during the day or at night, can have long-term effects, causing distress and embarrassment. While physiological incontinence is normal in early childhood, it becomes pathological after the age of five, with multifactorial causes including comorbidities. Neurogenic bladder conditions present with specific symptoms like recurrent UTIs and thickened bladder walls, while non-neurogenic bladder issues, such as the HINMAN Syndrome, exhibit similar signs. Behavioral and emotional disorders often accompany urinary incontinence, exacerbating its social, emotional, and psychological impact on children and families. The study seeks to assess the quality of life of affected children and caregivers, identifying factors influencing their well-being and informing interventions to improve their quality of life outcomes. Such research is crucial for understanding and addressing the complex challenges associated with pediatric urinary incontinence, aiming to provide better support and care for affected individuals and their families. |