| CTRI Number |
CTRI/2015/10/006298 [Registered on: 23/10/2015] Trial Registered Prospectively |
| Last Modified On: |
03/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pre Experimental evaluative] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Visual observation of the skills of undergraduate nursing students to perform the maternal care |
|
Scientific Title of Study
|
A descriptive study to assess maternity clinical skills by Direct Observation of Procedural Skills (DOPS)for undergraduate nursing students in a selected nursing college of Mangalore. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balary N Sympli |
| Designation |
P G Student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Khliehriat West
East Jainthia Hills
Meghalaya
Khliehriat West
East Jainthia Hills
Meghalaya
Jaintia Hills
MEGHALAYA
793200
India |
| Phone |
7466744264 |
| Fax |
|
| Email |
symplibalary1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alphilin Jose |
| Designation |
Lecturer |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangalore
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9916528629 |
| Fax |
|
| Email |
alphilinjose86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alphilin Jose |
| Designation |
Lecturer |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangalore
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9916528629 |
| Fax |
|
| Email |
alphilinjose86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller College of Nursing
Father Muller Road
FMCI
Kankanady
Mangalore
575002
DK |
|
|
Primary Sponsor
|
| Name |
Balary N Sympli |
| Address |
C/O Krasius Nongtdu
Khliehriat West Road
East Jainthia Hills
Meghalaya
793200 |
| Type of Sponsor |
Other [self funded] |
|
|
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 Savitha Pramilda Cutinho |
Father Muller Medical College Hospital |
Unit No H Room no 2
Antenatal and Postnatal ward
Father Muller Medical College Hospital
FMCI
Kankanady
Mangalore
575002
Dakshina Kannada
KARNATAKA |
9740687444
savithacutinho@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants of the study will be the fourth year basic B.Sc Nursing undergraduate students who are healthy and willing to participate |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DOPS |
Direct observation of selected procedural skills of fourth year Basic BSc nursing student during antenatal and postnatal care performing according to the clients needs under supervision of clinical instructors |
| Comparator Agent |
DOPS skill assessment |
Not excellent as below 90 percent |
| Comparator Agent |
DOPS Observation Checklist |
Assessing the level of skills
as Excellent as above 90 percent skills |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Both |
| Details |
Students who have attended minimum 80% of the OBG theory classes
Students who have completed minimum 1 month of clinical experience in antenatal and postnatal wards.
Students who have completed the log book requirements of 3rd year B.Sc. Nursing.
|
|
| ExclusionCriteria |
| Details |
Students on medical leave
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will reveal the skills of undergraduate nursing students to perform the maternity procedures |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The students who have poor skills will be identified and extra training will be given to become skillful midwives. |
1 year |
|
|
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)
|
04/01/2016 |
| 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="6"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Nursing is core part in health service delivery system in which health promotion, disease prevention; curative and rehabilitative health strategies are applied. The clinical nursing skills for the nurses are of paramount important not only to provide comprehensive care but also enhance clinical competence. The current problems of clinical teaching are lack of observation and inadequate feedback to the student. While doing procedure the teacher should remain with the student and observe properly rather than ask the student to explain about the findings, where students receives feedback about the progress being made. The present study will find out the skills of undergraduate nursing student’s skill to perform the maternity procedures. The main Objectives of the study are
To determine maternity clinical skills of undergraduate nursing students by using Observation Checklist
1. To find the association of maternity clinical skills with demographic variables 1. |