| CTRI Number |
CTRI/2024/02/063325 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Stress, coping and Quality of life among parents of children with chronic illness |
|
Scientific Title of Study
|
A cross-sectional study to assess the stress, coping and quality of life among parents of children with chronic illness in selected hospitals of Udupi District, Karnataka. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jean Elizabeth Biju |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Nursing, Manipal Academy of Higher Education |
| Address |
Dept. of Child Health Nursing
2nd floor
Manipal College of Nursing
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9048594583 |
| Fax |
|
| Email |
jeanbiju26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu Margaret |
| Designation |
Assistant Professor Selection Grade |
| Affiliation |
Manipal College of Nursing, Manipal Academy of Higher Education |
| Address |
Dept. of Child Health Nursing
2nd floor
Manipal College of Nursing
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844602532 |
| Fax |
|
| Email |
binu.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binu Margaret |
| Designation |
Assistant Professor Selection Grade |
| Affiliation |
Manipal College of Nursing, Manipal Academy of Higher Education |
| Address |
Dept. of Child Health Nursing
2nd floor
Manipal College of Nursing
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844602532 |
| Fax |
|
| Email |
binu.m@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Jean Elizabeth Biju |
| Address |
Dept. of Child Health Nursing
2nd floor
Manipal College of Nursing
MAHE, Manipal |
| 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 Binu Margaret |
Kasturba Hospital |
Pediatric OPD, Ground floor
Pediatric wards, 2nd floor
Pediatric ICU, 2nd floor
Department of Pediatrics
Kasturba Hospital
Udupi
KARNATAKA |
9844602532
binu.m@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents of children with chronic illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Parents of children with chronic illness such as seizure disorder, cerebral palsy, autism, bronchial asthma, cystic fibrosis, pulmonary hypertension, global developmental delay (GDD), nephrotic syndrome, juvenile diabetes mellitus, inborn errors of metabolism, muscular dystrophy, spinal muscular atrophy, osteogenesis imperfecta, Down’s Syndrome, congenital hip dysplasia suffering for three months or more; who are coming to Pediatric outpatient department (OPD) or admitted in the Pediatric wards of selected hospitals of Udupi District, Karnataka.
Parents who are available during data collection.
Parents who are able to read and write Kannada or English.
|
|
| ExclusionCriteria |
| Details |
Parents who are unwilling to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stress, coping and quality of life |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="195"
Sample Size from India="195"
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)
|
05/03/2024 |
| 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 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
|
This cross-sectional aims to assess the level of stress, coping and quality of life among parents of children with chronic illness and find the relationship between them. The findings from the study will give a baseline information to the healthcare professionals to help alleviate stress and to cope with the situation, thereby, to improve the quality of life among parents undergoing similar situation. The hypothesis of the study is to find relationship between stress, coping and quality of life. |