| CTRI Number |
CTRI/2024/11/076941 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
DESCRIPTIVE STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of the Usefulness Satisfaction and Challenges of the Denver Developmental Screening Test-2 (DDST-2) for Screening Children Under Five by Nursing Interns in Selected Nursing Colleges of Uttar Pradesh |
|
Scientific Title of Study
|
A Study to Assess Utility, Satisfaction and perceived problem of screening of Under Five Children Using Denver Developmental Screening Test-2(DDST-2) Among Nursing Interns In Selected Nursing Colleges of Uttar Pradesh |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRAMOD KUMAR |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Nursing, Uttar Pradesh University of Medical Sciences |
| Address |
ROOM NO 207 Department of Community Health Nursing Faculty of Nursing Uttar Pradesh University of Medical Sciences Saifai Etawah UP 206130
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7056195947 |
| Fax |
|
| Email |
pramodkumarsikarawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr S P Subashini |
| Designation |
DEAN, NURSING |
| Affiliation |
TEERTHANKER MAHAVEER COLLEGE OF NURSING TEERTHANKER MAHAVEER UNIVERSITY |
| Address |
Room No 101 Department of Medical Surgical Nursing Teerthanker Mahaveer College Of Nursing Teerthanker Mahaveer University Delhi Road Nh 24 Bagadpur Moradabad Up 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
6399000660 |
| Fax |
|
| Email |
subashiniphd2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr S P Subashini |
| Designation |
DEAN NURSING |
| Affiliation |
TEERTHANKER MAHAVEER COLLEGE OF NURSING TEERTHANKER MAHAVEER UNIVERSITY |
| Address |
Room No 101 Department of Medical Surgical Nursing Teerthanker Mahaveer College Of Nursing Teerthanker Mahaveer University Delhi Road Nh 24 Bagadpur Moradabad Up 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
6399000660 |
| Fax |
|
| Email |
subashiniphd2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mr Pramod Kumar ROOM NO 207 Department of Community Health Nursing Faculty of Nursing Uttar Pradesh University of Medical Sciences Saifai Etawah UP 206130 |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer University |
| Address |
Teerthanker Mahaveer University Delhi Road Nh 24 Bagadpur Moradabad Up 244001 |
| Type of Sponsor |
Private medical college |
|
|
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 PRAMOD KUMAR |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
ROOM NO 207 Department of Community Health Nursing Faculty of Nursing Uttar Pradesh University of Medical Sciences Saifai Etawah UP 206130
Etawah
UTTAR PRADESH |
7056195947
pramodkumarsikarawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthanker Mahaveer University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY NURSING INTERN STUDENTS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NOT APPLICABLE |
NOT APPLICABLE |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Students who are in:
1 Students of B.Sc. nursing 4th year.
2 Alert, oriented and able to comprehend and speak.
3 Are willing to participate in the study
4 Are available during data collection period
|
|
| ExclusionCriteria |
| Details |
Students who are:
1 Not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To assess the Utility of screening of Under Five Children Using Denver Developmental Screening Test-2(DDST-2) Among Nursing Interns
2 To assess the Satisfaction of screening of Under Five Children Using Denver Developmental Screening Test-2(DDST-2) Among Nursing Interns
2 To assess the perceived problem of screening of Under Five Children Using Denver Developmental Screening Test-2(DDST-2) Among Nursing Interns
|
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
10/12/2024 |
| 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
|
Developmental screening is a procedure of brief testing which is formulated to recognize the children who require more and in depth diagnosis. Screening authorize to the detection of divergence from normal development that would not be else ways identified in routine pediatric practice. The major aim of screening is as early as possible identify, developmental disabilities in children who are at high risk so that treatment or remediation can be initiated at an early stage . Premier screening is a set of action and procedures used over a period of time; it is not solely mean the administration of a single test at one point of time. As many studies suggested and evidenced that DDST-II is being used in many countries to assess the status of children between the age group (0-5yrs), but there are less evidences which suggest the use of DDST-II in India Scenario. Hence keeping in view the current study was decided to identify the utility, satisfaction and perceived problems in using DDST-II among Indian Nursing Interns. PROBLEM STATEMENT: A Study to Assess Utility, Satisfaction and perceived problem of screening of Under Five Children Using Denver Developmental Screening Test-2(DDST-2) Among Nursing Interns In Selected Nursing Colleges of Uttar Pradesh HYPOTHESES The following Hypotheses will be tested at 0.05 level of significance H1:-There will be significant presence of Utility of screening of Under Five Children Using Denver Developmental Screening Test-2(DDST-2) Among Nursing Interns. H2:- There will be significant Absence of Satisfaction of screening of Under Five Children Using Denver Developmental Screening Test-2(DDST-2) Among Nursing Interns. H3:- There will be significant presence of perceived problem of screening of Under Five Children Using Denver Developmental Screening Test-2(DDST-2) Among Nursing Interns.
|