| CTRI Number |
CTRI/2026/03/105277 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Teaching method of simulation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Simulation-Based Teaching on Normal Labour Management Skills Among Nursing Students |
|
Scientific Title of Study
|
A pilot study to assess the Efficacy of Birth simulator assisted teaching on Level of competence in managing Normal labour among the undergraduate Nursing students of a selected college in Western Maharashtra: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roshni B |
| Designation |
Asst Professor |
| Affiliation |
Armed forces medical college |
| Address |
Room NO. 5, Dept of Obstetrics & Gynecological Nursing, College of Nursing, Armed forces medical college, Pune 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
9549476474 |
| Fax |
|
| Email |
roshni.arien@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Roshni B |
| Designation |
Asst Professor |
| Affiliation |
Armed forces medical college |
| Address |
Room No.5, Dept of Obstetrics & Gynecological Nursing, College of Nursing, Armed forces medical college, Pune 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
9549476474 |
| Fax |
|
| Email |
roshni.arien@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Roshni B |
| Designation |
Asst Professor |
| Affiliation |
Armed forces medical college |
| Address |
Room No.5, Dept of Obstetrics & Gynecological NUrsing, College of Nursing, Armed forces medical college, Pune 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
9549476474 |
| Fax |
|
| Email |
roshni.arien@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anveshan Project, Armed Forces Medical College, Pune, Maharashtra, India- 411040 |
|
|
Primary Sponsor
|
| Name |
Armed forces medical college |
| Address |
Armed forces medical college Pune, Maharashtra, India-411040 |
| Type of Sponsor |
Government 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 |
| Roshni |
College of Nursing AFMC , wanowrie Pune-411040 |
Room No.2 Skill lab Scientia, Dept of Obstetrics & GYnecological Nursing.
Pune
MAHARASHTRA |
9549476474
roshni.arien@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ARMED FORCES MEDICAL COLLEGE, SOLAPUR ROAD, PUNE-411040 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy physically & Mentally volunteers
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Simulator based midwifery training |
Intervention group will be getting 6 sessions of simulation based training for 06 weeks on managing normal labour before going for a practice in labour room |
| Comparator Agent |
Students will continue to have conventional training which is followed in the college |
Routine lectures and skill lab training before going for practice in labour room |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
25.00 Day(s) |
| Gender |
Female |
| Details |
Nursing undergraduate students |
|
| ExclusionCriteria |
| Details |
Psychologically unwell students |
|
|
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 Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of simulation based training in managing normal labour |
06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Satisfaction level of undergraduate students in training |
06 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/03/2026 |
| 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
|
Effective management of normal labour is a core clinical competency for undergraduate nursing students. Traditional teaching methods may provide limited opportunities for hands-on practice, which can affect students’ confidence and skill acquisition. Simulation-based teaching, particularly through birth simulators, offers a safe and structured environment for students to practice and refine their clinical skills without risk to patients.
This randomized controlled study aims to assess the efficacy of birth simulator–assisted teaching on the level of competence in managing normal labour among undergraduate nursing students. The study compares simulation-based teaching with conventional teaching methods to determine its effectiveness in enhancing knowledge and clinical performance.
|