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CTRI Number  CTRI/2024/08/072102 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Effect of Simulation-based Education .]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Study to assess the effect of Simulation-based Education on Critical thinking and Clinical competency regarding the management of Obstetric Emergencies among undergraduate Midwifery Nursing students. 
Scientific Title of Study   A Study to assess the effect of Simulation-based Education on Critical thinking and Clinical competency regarding the management of Obstetric Emergencies among undergraduate Midwifery Nursing students. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Deepak 
Designation  Associate Professor 
Affiliation  Shree Guru Gobind Singh Tricentenary University, Gurugram, Haryana 
Address  Faculty of Nursing Department of Obstetrics and Gynaecological Nursing Room No. 101 D Block Shree Guru Gobind Singh Tricentenary University Budhera Gurugram-Badli Road Gurugram

Gurgaon
HARYANA
122505
India 
Phone  8699247528  
Fax    
Email  deepakgautam286@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Latha Venkatesan 
Designation  Principal 
Affiliation  College of Nursing All India Institutes of Medical Sciences New Delhi 
Address  Department College of Nursing Room No. 1 All India Institutes of Medical Sciences New Delhi

New Delhi
DELHI
110029
India 
Phone  9310502069  
Fax    
Email  latha6901@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Latha Venkatesan 
Designation  Principal 
Affiliation  College of Nursing All India Institutes of Medical Sciences New Delhi 
Address  Department College of Nursing Room No. 1 All India Institutes of Medical Sciences New Delhi


DELHI
110029
India 
Phone  9310502069  
Fax    
Email  latha6901@yahoo.com  
 
Source of Monetary or Material Support  
Shree Guru Gobind Singh Tricentenary University Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India.  
 
Primary Sponsor  
Name  Mrs Deepak 
Address  Shree Guru Gobind Singh Tricentenary University Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India.  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mrs Deepak  Shree Guru Gobind Singh Tricentenary University Gurugram  National Reference Simulation Centre Fourth Floor C Block Shree Guru Gobind Singh Tricentenary University Gurugram, Haryana India
Gurgaon
HARYANA 
8699247528

deepakgautam286@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGT Medical College Hospital Chandu, Budhera, Gurugram-Badli Road Gurugram Gurugram Gurugram Haryana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nursing students Critical thinking and clinical competency regarding the management of Obstetric Emergencies  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Simulation based education  The Simulation-based Education Module will be imparted over a training period of 5 days (5hours/day) Students in Experimental group will be divided into 5 subgroups during the training period Each group will attend training for 5 days (5hours/day) 
Comparator Agent  Traditional Teaching Methodology  Traditional Teaching Methodology includes lab Demonstrations abd bed side teaching. it will be imparted as per their course plan by their respective teachers. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  Nursing Students who have cleared all subjects till the third year of B.Sc. Nursing Programme.
Nursing Students with a minimum 80% attendance in theory classes of Midwifery/Obstetrics and Gynecological Nursing Subject.
 
 
ExclusionCriteria 
Details  Nursing Students who are not willing to participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome 1-Clinical competency of undergraduate Midwifery Nursing students regarding the management of Obstetric Emergencies
Primary Outcome 2- Critical thinking of undergraduate Midwifery Nursing students regarding the management of Obstetric Emergencies  
Pretest for both outcomes will be conducted for both groups to obtain baseline information one week before the intervention.
Post test will be conducted after one week of the intervention for both control and experimental group. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) 03/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Research Statement

A Study to assess the effect of Simulation-based Education on Critical thinking and Clinical competency regarding the management of Obstetric Emergencies among undergraduate Midwifery Nursing students.

Objectives

1.     To assess the effect of simulation-based education on Critical thinking skills regarding the management of Obstetric Emergencies among Undergraduate Midwifery nursing students. 

2.     To assess the effect of simulation-based education on Clinical Competency regarding the management of Obstetric Emergencies among Undergraduate Midwifery nursing students.

3.     To assess the relationship between Clinical Competency and Critical thinking regarding the management of Obstetric Emergencies among Undergraduate Midwifery nursing students

Hypothesis

H1: There will be a significant difference between the mean post-test Critical thinking score in the experimental and control groups at 0.05 level of significance.

H2: There will be a significant difference between the mean post-test Clinical Competency score in the experimental and control groups at 0.05 level of significance.

H3: There will be a significant relationship between the post-test Critical thinking and Clinical Competency score at 0.05 level of significance

Assumptions

1.      Undergraduate Midwifery Nursing students may be lacking critical thinking skill and Clinical Competency for the management of obstetric emergencies.

2.     Simulation-based education will enable students to develop adequate critical thinking skills and Clinical Competency for managing obstetric emergencies.

Delimitations

1.     The study will be delimited to undergraduate Midwifery Nursing students.

2.     The study will be delimited to selected colleges of Delhi NCR.

Operation Definitions

1.     Simulation-based Education refers to a module that will include Skill Training, Case Studies, and Simulation Scenario related to Obstetric Emergencies.

2.     Clinical Competency: It refers to Psychomotor skills that enable a Nursing student to deliver high-quality patient care as assessed by Objective structured clinical examination.

3.     Critical Thinking: It refers to the ability of students to thoughtfully analyze and evaluate complex situations and make informed clinical judgments as assessed by EMOC-CTAT (Emergency Obstetric Care-Critical Thinking Tool)

4.     Operation Definitions

5.     Undergraduate Midwifery Students: It refers to B.Sc. Nursing Final year students studying Midwifery/Obstetrics and Gynecological nursing and Post Basic B.Sc. Nursing 1st year students studying Maternal Nursing in institutions recognized by the Indian Nursing Council. 

6.     Obstetric Emergencies: Obstetric emergencies refer to critical and potentially life-threatening situations that can occur during pregnancy, labor, childbirth, or the postpartum period, including Abruptio Placenta, Postpartum Hemorrhage, Eclampsia, and Shoulder Dystocia.

Research Methodology

Research Approach: Quantitative approach

Research Design: Non-equivalent Pretest-Post-test Control group Design

Research Setting: Selected Nursing colleges of Delhi NCR

Target Population: Undergraduate Midwifery Nursing students

Accessible Population: Undergraduate Midwifery Nursing students of Delhi NCR

Sample: Undergraduate Midwifery Nursing students of selected nursing colleges of Delhi NCR who fulfill inclusion and exclusion criteria

Sampling Technique: Simple Random sampling

Sample Size:  62(31 in each group) A priori sample size is calculated by G* Power software with 80% power, 5% significance level, 15% attrition rate)

Subjects will be allocated to experimental and control groups using computer-generated random numbers

Independent Variable: Simulation Based Education

Dependent Variables

·       Clinical Competency of Undergraduate Midwifery Nursing Students

·       Critical Thinking of Undergraduate Midwifery Nursing Students

Inclusion Criteria

·       Students who have cleared all subjects till the third year of B.Sc. Nursing Programme.

·       Students with a minimum 80% attendance in theory classes of Midwifery/Obstetrics and Gynecological Nursing Subject.

Exclusion Criteria

·       Students who are not willing to participate.

Tools and Techniques

Tools will be divided into three parts

Part A

Socio-demographical Profile

Part B

Tool to assess Critical thinking

 Part C

Tool to assess clinical Competence

 

Sr. No.

Tool

Description of tool

Technique

Purpose

A

Socio-demographic profile

It will consist of 5 items and collects data about socio-demographic profiles like Age, Gender, Area of Residence, Marks in Higher Secondary, Previous experience with Simulation

Self report, Paper and Pencil

To assess baseline variables and comparability of experimental and control group

B

EMOC-CTAT

(Emergency Obstetric Care-Critical Thinking Assessment Tool)

A self-structured tool will be developed consisting of 20 problem-based Multiple-choice questions (5 questions for each obstetric emergency) Participants will be given 30 minutes to complete the Questionnaire

Self report, Paper and Pencil

To assess Critical thinking

C

OSCE

Objective Structured Clinical Examination

A structured OSCE will be developed after an extensive literature review.

Direct One to One Observation at 4 stations

To assess clinical Competency

 

 

 















Reliability and Validity of the tools

·       Experts in the field of obstetrics and Gynecological Nursing will validate self-structured tools.

·       The Reliability of OSCE Checklist will be checked by interrater Reliability.

·       The Reliability of EMOC-CTAT (Emergency Obstetric Care-Critical Thinking Tool) will be assessed by split half method.

Intervention

Simulation based education

A simulation-based education module for the Management of Obstetric Emergencies will be developed consisting of:

Part A

Skill training checklists of Management of Abruptio Placenta, Postpartum Haemorrhage, Eclampsia and Shoulder Dystocia

Part B:

Case Studies of Abruptio Placenta, Postpartum Haemorrhage, Eclampsia and Shoulder Dystocia

Part B

Simulation Scenario of Abruptio Placenta, Postpartum Haemorrhage, Eclampsia and Shoulder Dystocia

The module will be developed after an extensive literature review following Govt. of India Guidelines. It will be validated by experts from the field of Obstetrics and Gynaecology The Simulation-based Education Module will be imparted over a training period of 5 days (5hours/day) Students in Experimental group will be divided into 5 subgroups  during the training period  Each group will attend training for 5 days (5hours/day)

Pilot Study Plan

After obtaining the ethical clearance and testing the validity and reliability of the tools, a pilot study will be conducted on 10 Post Basic B.Sc. Nursing 1st year students  5 in each group.

Data Collection

Phase I: Recruitment of Subjects

·       Subjects will be enrolled using Simple Random sampling techniques from selected colleges of Delhi NCR.

·       Students from the institution where the Simulation Facility is available will be placed in the Experiment group, and the Students from the institution where the Simulation Facility is not available will be placed in the Control group.

·       31 subjects will be placed in each group according to inclusion-exclusion criteria using computer-generated random numbers.

·       Students will be explained about the purpose of the study, and all queries will be addressed and Informed consent will be taken.

·       Sociodemographic Data will collected to ensure the homogeneity of groups.

Phase II: Pretest

·       Pretest will taken from both groups to obtain baseline information one week before the intervention.

Phase III- Intervention

·       Simulation based education will be given to experiment group.

·       Students of the control group will receive traditional midwifery training as per the syllabus.

Phase IV- Post test

·       Post test will be conducted after one week of the intervention and before clinical posting of both control and experimental group.

Plan of Data Analysis and Statistical Application

·       After the data collection, descriptive and inferential statistics will be used for the data analysis using a statistical program- IBM’s Statistical Package for the Social Sciences (SPSS).

·       A statistical significance of 0.05 (p< 0.05) will be adopted throughout the study.

·       Descriptive statistics like frequency percentage will be used to describe demographical characteristics of both groups.

·       Independent t test will be used to test Hypothesis 1 and 2

·       Karl Pearson’s coefficient of correlation will be used to test Hypothesis 3

 
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