| CTRI Number |
CTRI/2024/01/062061 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
06/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ASTHMA EDUCATION ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Nurse Led Intervention on caregivers burden in caregivers of asthmatic children |
|
Scientific Title of Study
|
Effectiveness of Nurse-led Intervention on asthmatic parameters, Burden, self-efficacy, QOL and to explore the stress and experiences among caregivers of asthmatic school age children -A Mixed Method 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 |
Ms Ushapriya M |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of science and technology |
| Address |
Department Child Health nursing, Room no 301, Third Floor, SRM College of Nursing SRM Institute of science and technology, SRM Nagar, Kattankulathur, Chengalpattu dt 603203
Department of Child health Nursing, Room no 301, Third Floor, SRM College of Nursing SRM Institute of science and technology, SRM Nagar, Kattankulathur, Chengalpattu dt 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8940597167 |
| Fax |
|
| Email |
ushapriyansg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeswari D |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of science and technology |
| Address |
room no 101 Department of community health nursing SRM College of Nursing
SRM Institute of science and technology
SRM Nagar Kattankulathur
Chengalpattu dt 603203
room no 101 Department of community health nursing SRM College of Nursing
SRM Institute of science and technology
SRM Nagar Kattankulathur Chengalpattu dt 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9962061436 |
| Fax |
|
| Email |
rajeswad1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeswari D |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of science and technology |
| Address |
room no 101 Department of community health nursing SRM College of Nursing
SRM Institute of science and technology
SRM Nagar Kattankulathur
Chengalpattu dt 603203
room no 101 Department of community health nursing SRM College of Nursing
SRM Institute of science and technology
SRM Nagar Kattankulathur Chengalpattu dt 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9962061436 |
| Fax |
|
| Email |
rajeswad1@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics, SRM Medical College Hospital and Research Center |
|
|
Primary Sponsor
|
| Name |
Ms.Ushapriya M |
| Address |
2/85 West street, Melakalpoondi , Keelakalpoondi POST , Titagudi tk Cuddalore dt 606303 |
| Type of Sponsor |
Other [self funding] |
|
|
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 |
| MsUshapriya M |
SRM Medical College Hospital and Research Center |
Room No: 22 Department of Pediatrics, SRM Medical College Hospital and Research center
SRM Nagar
Kattankulathur
Chengalpattu dt
Kancheepuram
TAMIL NADU |
8940597167
ushapriyansg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEdical College Hospital and Research center, INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASTHMATIC CHILDREN CAREGIVERS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Asthma Education program |
The nurse-led intervention procedure will be administered by a licensed nurse. 1 week structured Asthma education program will be taught to the care givers. At the conclusion of the intervention regimen, a post-test evaluation will be conducted |
| Comparator Agent |
Conventional care will be given |
Conventional care including patient advice, regular explanation about drug and advises given by pediatrician |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Caregivers who are willing to participate in this study were available at the time of data collection.
2. Male and female Caregivers
3. Able to read and speak English and Tamil
4. caregivers could clearly express their inner thoughts and experiences.
5. Caregivers living with the child in the same household for more than 6 months.
6. Caregivers (Mother, Father, Grandmother and Grandfather) involved in the primary care of the child.
7. Caregivers who agreed to comply with the intervention schedule in the setting.
8. Caregivers who were willing to share their views and concerns on stress in the care of children with childhood asthma.
|
|
| ExclusionCriteria |
| Details |
1. Caregivers of non-asthmatic children
2. Caregivers who attended previous asthma education programme
3. caregivers had psychological or physical disorders that affected their ability to communicate.
4. Children whose parents are not agreeing to participate their child in the study.
5. Caregivers’ who was part of similar study in the past 6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| asthmatic parameters, burden, self efficacy, quality of life , stress |
Before and after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depression, Anxiety |
Before and after the intervention |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="2"
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
|
Purpose of the research
Paediatric asthma is a serious public health problem around the world. The World
Health Organization estimated that approximately 300 million people currently have asthma
worldwide, and with current trends rising, it is expected to reach 400 million by 2025. Nearly
250,000 people die prematurely each year from asthma, and most of all these deaths are
preventable. Globally, death rates from asthma in children range from 0 to 0.7 per 100,000
people. Among children, asthma is the most common chronic disease, ranking among the top
20 conditions worldwide for disability-adjusted life years in children. Parents and other
caregivers play a crucial role in the growth and development of their children; they have a
SRM COLLEGE OF NURSING
SRM IST
variety of duties and obligations that shift as the child progresses through different stages.
The life of the child’s carers, however, might be significantly impacted by any divergence
from the child’s typical course.
Procedures and Protocol
Informed consent will be requested before hiring caregivers based on inclusion and exclusion
criteria. By using the closed-envelope method and computer-generated random numbers, all
participants will be split into study and control groups. Before the start of the interventions, a pretest
examination will be conducted. The nurse-led intervention procedure will be administered by a
licensed nurse. At the conclusion of the intervention regimen, a post-test evaluation will be conducted
Expected Benefits
There may or may not be any benefit for you but your participation is likely to help us find
the answer to the research question. There may not be any benefit to society at this stage of the
research, but future generations are likely to benefit.
|