| CTRI Number |
CTRI/2025/01/079356 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Video assisted debriefing] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Video-Assisted Debriefing on Eclampsia Management Skills in Nursing Students |
|
Scientific Title of Study
|
Effectiveness of video assisted debriefing on development of technical and non-technical skills in managing eclampsia among Nursing students College of Nursing AIIMS Gorakhpur: A Randomized Control 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 |
Ms Mahima |
| Designation |
PG Student |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
College of Nursing AIIMS Gorakhpur
273008
Uttar Pradesh India
VPO Mokhra Khas Panna Shyam Tehsil Meham, District Rohtak
124002
Haryana
India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9053945909 |
| Fax |
|
| Email |
mahimamalik63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deviga T |
| Designation |
Assistant Proffesor |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Faculty room no 4 fourth floor MNC building College of Nursing AIIMS Gorakhpur Uttar Pradesh
273008 India
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 Proffesor |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Faculty room no 4 fourth floor MNC building College of Nursing AIIMS Gorakhpur Uttar Pradesh
273008 India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8003991332 |
| Fax |
|
| Email |
deviga.thirush@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing, ALL India Institute of Medical Sciences Gorakhpur. Kunraghat Gorakhpur Uttar Pradesh
273008
India |
|
|
Primary Sponsor
|
| Name |
Ms Mahima |
| Address |
College of Nursing AIIMS Gorakhpur 273008 Uttar Pradesh India |
| 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 |
AIIMS Gorakhpur |
4th floor Skill Lab College of Nursing AIIMS Gorakhpur Uttar Pradesh
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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nursing UG students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Traditional oral debriefing |
Traditional oral debriefing will be done after simulation. This is traditional method where verbally explained about technical and non technical skills learned from simulation on management of eclampsia. |
| Intervention |
video assisted debriefing |
Video assisted debriefing among nursing students for developing technical and non technical skills in managing eclampsia
Video assisted debriefing will be practiced during debriefing sessions for scenario in managing eclampsia to address technical skill and non technical skills.
Participants will be recruited for the study informed consent will be taken. Random allocation of participants using computer generated list.
Management of eclampsia will be practiced under 4 sub categories. It includes identification of eclampsia, initial management of eclampsia, medical management of eclampsia and obstetric management of eclampsia. Where the procedural activities count in technical skills and non technical skill comprises situation awareness, decision making, communication and team work and Leadership.
After explaining clear objective, ensuring psychological safety and obtaining verbal consent for video recording of performed scenarios. Recorded videos of these scenarios will be for education purpose only and will be deleted after completion of data collection.
Day 1 pretest will be conducted followed by practice on same day and following 2 days.
Day 2, 3 are practice day. Day 4 post test will be conducted to obtain data on technical and non technical skills for management of eclampsia. This will cover 3 type of eclampsia antepartum, intrapartum and postpartum eclampsia. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Female |
| Details |
The B.Sc. Nursing Hons. Students who are in 3rd year & 4th year of their UG degree program at College of Nursing, AIIMS Gorakhpur.
The B.Sc. Nursing Hons. students who are willing to acquire technical and non technical skills in managing eclampsia. |
|
| ExclusionCriteria |
| Details |
The B.Sc. Nursing Hons. students who had previously been for simulation type of training on eclampsia.
The B.Sc. Nursing Hons. students who will not be available at time of allocation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the technical skills in managing eclampsia among nursing students in the experimental and control group before and after intervention.
To assess and compare the non-technical skills in managing eclampsia among nursing students in the experimental and control group before and after the intervention
|
day 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association between technical and non technical skills with selected socio demographic variables. |
day 4 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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
|
The study is randomized control trial that will be conducted at All India Institute of Medical Sciences Gorakhpur among the UG nursing students on the management of eclampsia. to assess the effectiveness of Video assisted debriefing among nursing students for developing technical and non technical skills in managing eclampsia. The true experimental design pre test post test only control design is used in the study. The population of this study includes UG nursing students from AIIMS Gorakhpur. A total of 60 students will be chosen and will be allocated to experimental group and control group with the computer generated software. Management of eclampsia will be practiced under 4 sub categories. It includes identification of eclampsia, initial management of eclampsia, medical management of eclampsia and obstetric management of eclampsia. Where the procedural activities count in technical skills and non technical skill comprises situation awareness, decision making, communication, team work and Leadership. After explaining clear objective, ensuring psychological safety and obtaining verbal consent for video recording of performed scenarios. Recorded videos of these scenarios will be for education purpose only and will be deleted after completion of data collection. Day 1 pretest will be conducted followed by practice on same day and following 2 days. Day 2, 3 are practice day. Day 4 post test will be conducted to obtain data on technical and non technical skills for management of eclampsia. This will cover 3 type of eclampsia antepartum, intrapartum and postpartum eclampsia. There will be a significant difference in technical skills among UG nursing students between the experimental and control group. There will be a significant difference in non technical skills among UG nursing students between the experimental and control group. There will be significant association between technical and non technical skills in selected socio demographic variables. follow up assessment will be done after 2 weeks of video assisted debriefing in managing eclampsia. |