| CTRI Number |
CTRI/2025/11/097149 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Simulation-Based Learning to Improve Skills in Active Management of the Third Stage of Labour |
|
Scientific Title of Study
|
Effectiveness of low-fidelity simulation-based training in practical competency of active management of third-stage labour and perspectives of simulation,among final year nursing students at AIIMS Bhubaneswar |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Indumathi |
| Designation |
Tutor |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
room no13
4 th floor colloege of nursing AIIMS-bhubaneswar
college of nursing AIIMSBhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
08438972403 |
| Fax |
|
| Email |
samyusakshitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P Indumathi |
| Designation |
Tutor |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
room no13 4 th floor college of nursing AIIMS Bhubaneswar
college of nursing AIIMSBhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
08438972403 |
| Fax |
|
| Email |
samyusakshitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
P Indumathi |
| Designation |
Tutor |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
room no13 4 th floor college of nursing AIIMS Bhubaneswar
college of nursing AIIMSBhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
08438972403 |
| Fax |
|
| Email |
samyusakshitha@gmail.com |
|
|
Source of Monetary or Material Support
|
| AII INDIA INSTITUTE OF MEDCIAL SCIENCE BHUBANESAR
INDIA
PIN 751019
|
|
|
Primary Sponsor
|
| Name |
PIndumathi |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
BHUBANESWAR INDIA
Pin 751019 |
| Type of Sponsor |
Other [self] |
|
|
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 P INDUMATHI |
AII INDIA INSTITUTE OF MEDICAL SCIENCE- HOSPITAL |
ROOM NO 13 4TH FLOOR COLLEGE OF NURSING
AII INDIA INSTITUTE OF MEDICAL SCIENCE
BHUBANESWAR
Khordha
ORISSA |
8438972403
samyusakshitha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALLINDIA INSTITUTEOFMEDICALSCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nursing students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
compartor |
demonstration on manniquin |
| Intervention |
Intervention |
low fidelity simulation training-The mannequin prepared to replicate key aspects of maternal physiology during the third stage with moulage and props. The mannequin allows for
the practice of critical interventions, such as the administration of uterotonics, controlled cord traction, and uterine massage.
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Female |
| Details |
Final year nursing students are those who all studied obstetrics and midwifery curriculum. |
|
| ExclusionCriteria |
| Details |
Final year nursing students who are not giving their willingness
Those who attended already simulation based learning in Active management of third stage labour.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gaining practical competency on active management of third stage labour. |
After 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perspectives of simulation based learning |
After 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [samyusakshitha@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study aims to evaluate the effectiveness of low-fidelity simulation-based training in improving the practical competency of 4th-year nursing students in the active management of the third stage of labour (AMTSL) and to assess their perspectives and satisfaction toward simulation-based education. |