| CTRI Number |
CTRI/2025/02/080324 [Registered on: 11/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Obstetrical Emergency Skills in Final-Year Nursing Students Through Peer Coaching: A Study on Training Effectiveness |
|
Scientific Title of Study
|
Evaluating the effectiveness of simulation based peer coaching on obstetric emergency management skills in final year nursing students - A mixed method approach. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deviga T |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Faculty room number: 4
4th floor
MNC building
College of Nursing
AIIMS Gorakhpur
Uttar Pradesh
PIN 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8003991332 |
| Fax |
|
| Email |
deviga.thirush@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deviga T |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Faculty room number: 4
4th floor
MNC building
College of Nursing
AIIMS Gorakhpur
Uttar Pradesh
PIN 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8003991332 |
| Fax |
|
| Email |
deviga.thirush@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deviga T |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Faculty room number: 4
4th floor
MNC building
College of Nursing
AIIMS Gorakhpur
Uttar Pradesh
PIN 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8003991332 |
| Fax |
|
| Email |
deviga.thirush@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing
AIIMS Gorakhpur
Gorakhpur
Uttar Pradesh
India
PIN: 273008 |
|
|
Primary Sponsor
|
| Name |
Dr Deviga T |
| Address |
College of Nursing
AIIMS Gorakhpur
Gorakhpur
Uttar Pradesh
India
PIN: 273008 |
| 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 Deviga T |
All India Institute of Medical Sciences Gorakhpur |
4th floor
Skill lab
College of Nursing
MNC building
Gorakhpur
UTTAR PRADESH |
8003991332
deviga.thirush@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, AIIMS Gorakhpur, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Simulation-Based Training |
1.Simulation Scenarios:
oParticipants will engage in simulated scenarios of obstetric emergencies similar to those in the experimental group.
oScenarios will be designed to provide exposure to obstetric emergencies and allow participants to practice their clinical skills.
2.Facilitated Debriefing:
oFollowing each simulation session, participants will engage in facilitated debriefing sessions.
oFacilitators will lead discussions to review the simulation experience, identify learning points, and discuss areas for improvement.
3.No Peer Coaching:
oUnlike the experimental group, participants in the control group will not receive peer coaching during the simulation sessions.
Feedback and discussion will be led by facilitators rather than peers. |
| Intervention |
Simulation-Based Peer Coaching |
1.Simulation Scenarios:
Participants will engage in simulated scenarios of obstetric emergencies such as postpartum haemorrhage, eclampsia, and maternal CPR
Scenarios will be designed to mimic real-life situations encountered in clinical practice.
2.Peer Coaching Sessions:
oEach simulation session will be followed by a peer coaching session.
oPeer coaches, selected from among the participants, will observe their peers performance during the simulation and provide constructive feedback.
oFeedback will focus on clinical skills, decision-making processes, communication, and teamwork.3.Facilitated Reflection:
oFollowing feedback from peer coaches, participants will engage in facilitated reflection sessions.
oFacilitators will guide discussions to encourage participants to reflect on their performance, identify areas for improvement, and discuss strategies for enhancing their skills.
4.Repeated Practice:
oParticipants will have multiple opportunities to engage in simulation-based scenarios and peer coaching sessions throughout the intervention period.
The repetition of practice sessions aims to reinforce learning and skill acquisition. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1.Final-year B.Sc. nursing students studying at AIIMS Gorakhpur.
2.Students who have completed all required OBG clinical rotations of third-year.
3.Availability to attend training sessions and participate in assessments. |
|
| ExclusionCriteria |
| Details |
1.Students not willing to participate.
2.Previous formal training in obstetric emergency management beyond the standard curriculum.
3.Any medical condition or circumstance interfering with participation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved obstetric emergency management skills in the experimental group.
|
5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Enhanced confidence and knowledge levels among peer-coached students.
•Valuable qualitative insights into the effectiveness of peer coaching in simulation training. |
5 weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
12/02/2025 |
| 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="1"
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
|
This study will be conducted among final-year nursing students at AIIMS Gorakhpur. The participants will be divided into two groups: the experimental group (n=26) will undergo simulation-based peer coaching, while the control group (n=26) will receive conventional simulation training led by faculty. Participants will be recruited using a total enumerative sampling technique, and randomization will be performed using a computer-generated random allocation method. The study will focus on basic obstetrical emergency procedures, including the initial management of postpartum hemorrhage, eclampsia, and maternal CPR. Training for both the experimental and control groups will be conducted simultaneously. A pretest and posttest will be administered to assess knowledge and skills before and after the training. Additionally, a focus group discussion will be held after the training to gather qualitative insights into the students’ experiences with simulation-based peer coaching in managing obstetrical emergencies. Quantitative and qualitative findings will be integrated to provide a comprehensive understanding of the intervention’s impact.
|