| CTRI Number |
CTRI/2026/02/104635 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nursing] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Simulation Training on Improving Knowledge, Decision-Making and Skills in the Management of Obstructed Labor Among Nursing Students in Haryana |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of simulation-based learning on management of obstructed labor in terms of Knowledge, decision-making ability and skills among nursing students at selected colleges of Haryana |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Sharma |
| Designation |
MSc. Nursing student |
| Affiliation |
Maharishi Markandeshwar College of Nursing Maharishi Markandeshwar Deemed to be University |
| Address |
Maharishi Markandeshwar College of Nursing Maharishi Markandeshwar Deemed to be University Mullana Ambala Pincode 134003 District Ambala Haryana
OBG and Gynaecology Department Room Number 215
Ambala
HARYANA
134003
India |
| Phone |
7988744631 |
| Fax |
|
| Email |
sharmamonika2909@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Simarjeet Kaur |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar College of Nursing Maharishi Markandeshwar Deemed to be University |
| Address |
Maharishi Markandeshwar College of Nursing Maharishi Markandeshwar Deemed to be University Mullana Ambala Pincode 134003 District Ambala Haryana
OBG and Gynaecology Department Room Number 215
Ambala
HARYANA
134003
India |
| Phone |
08059991569 |
| Fax |
|
| Email |
kaursimarjeet913@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Simarjeet Kaur |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar College of Nursing Maharishi Markandeshwar Deemed to be University |
| Address |
Maharishi Markandeshwar College of Nursing Maharishi Markandeshwar Deemed to be University Mullana Ambala Pincode 134003 District Ambala Haryana
OBG and Gynaecology Department Room Number 215
Ambala
HARYANA
134003
India |
| Phone |
08059991569 |
| Fax |
|
| Email |
kaursimarjeet913@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Deemed to be university MullanaAmbala |
| Address |
Maharishi Markandeshwar college of nursing, Mullana,Ambala |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Monika Sharma |
Maharishi Markandeshwar College of nursing, Mullana,Ambala |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Simarjeet Kaur |
Maharishi Markandeshwar College of Nursing Mullana |
Maharishi Markandeshwar College of Nursing Maharishi Markandeshwar Deemed to be University Mullana Ambala Pincode 134003 District Ambala Haryana
OBG & Gynaecology Department Room No.215
Maharishi Markandeshwar College of Nursing Maharishi Markandeshwar Deemed to be University Mullana Ambala Pincode 134003 District Ambala Haryana
OBG & Gynaecology Department Room No.215
Ambala
HARYANA |
08059991569
kaursimarjeet913@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-3523 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no intervention |
no intervention |
| Intervention |
Simulation Based Learning |
Simulation based learning on management of obstructed labor. It involves simulation session on most common causes of obstructed labor these are shoulder dystocia cephalopelvic disorder prolonged labor and occipito posterir position |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
BSc. nursing 7th semester students, who complete the pre-test, attend intervention and complete the post test. |
|
| ExclusionCriteria |
| Details |
BSc. nursing students, who absent at the time of intervention and post test. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| knowledge, decision making ability and skills regarding obstructed labor among BSc nursing 7th semester students |
the primary outcome will be assessed before the intervention and 15 days after completion of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| increase knowledge, decision making ability & skills among nursing students |
pre-test before intervention & 15 days after completion of the intervention |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
23/03/2026 |
| 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="1"
Months="1"
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
|
The intervention consisted of a structured simulation based sessions on obstructed labor which included shoulder dystocia, ceohalopelvic disproportion, prolonged labor and occipito posterior position ,which are common cause of obtucted labor. Intervention will be implemented for four subgroups of participants. The SBL session will include structured briefing, act of a realistic clinical scenario through role play, and guided debriefing conducted by the researcher. The debriefing will focus on facilitating reflection, improving knowledge, clinical performance, enhancing decision-making abilities and skills in the management of obstetric emergencies. The effectiveness of the intervention was evaluated through pre test and post test score in terms of knowledge, decision making ability and skills by using structured knowledge questionnaire, structured decision making ability questionnaire and observational checklist. |