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CTRI Number  CTRI/2025/08/093227 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Simulation Based Education]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Training nursing officers through simulation and interactive sessions to improve respectful maternity care for mothers during and after childbirth. 
Scientific Title of Study   Effectiveness of Respectful Maternity Care (RMC) Training in enhancing the competency of nursing officers at AIIMS Gorakhpur: An Open labelled 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  Sujata 
Designation  MSc Nursing Student 
Affiliation  College of Nursing, AIIMS Gorakhpur 
Address  College of Nursing MNC building AIIMS Gorakhpur Uttar Pradesh-273008 India

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9991341096  
Fax    
Email  sangwansujata@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deviga T 
Designation  Associate Professor 
Affiliation  College of Nursing, AIIMS Gorakhpur 
Address  College of Nursing MNC Building 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  Associate Professor 
Affiliation  College of Nursing, AIIMS Gorakhpur 
Address  College of Nursing MNC Building 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 
 
Primary Sponsor  
Name  Sujata 
Address  All India Institute of Medical Sciences Gorakhpur Kunraghat College of Nursing 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sujata  All India Institute of Medical Science  Labour room and In-Patient Department
Gorakhpur
UTTAR PRADESH 		 09991341096

sangwansujata@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Gorakhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nursing Officers  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Routine Standard care  Participants in the control group will continue their usual routine duties and receive the standard hospital orientation and guidelines for maternity care without any additional intervention or simulation-based training related to Respectful Maternity Care (RMC). They will not participate in the webinar or simulation sessions. After three weeks, a post-test assessment will be conducted using the same tools as the intervention group to compare the knowledge, clinical and soft skills, attitude, and practice related to RMC.  
Intervention  Simulation Based Education  Simulation-based training program among Nursing Officers for improving their knowledge, clinical and soft skills, attitude, and practice related to Respectful Maternity Care (RMC) by giving them demonstrations and redemonstrations through realistic scenarios. Participants will be recruited for the study and informed consent will be taken. Random allocation of the participants will be done using a computer-generated list. A seminar will be conducted on one day for 2 hours, followed by simulation practice for 2 hours per day for 2 consecutive days (total 6 hours), focusing on RMC principles. The training period will therefore last three consecutive days. On the fifth day, a post-test assessment will be carried out to evaluate the effectiveness of the intervention. Total duration of intervention 5 consecutive days including assessments seminar simulation-based training 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Nursing officers working in OBG complex (Labor room, Postnatal Ward) and Nursing officers willing to attend training sessions and participate in assessments
 
 
ExclusionCriteria 
Details  On leave or unavailable during the study period and Individuals who are not interested to participate in whole training session
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
There will be an improvement in level of knowledge, clinical skills, soft skills, attitude and practice after the simulation- based training program among nursing officers  4th week 
 
Secondary Outcome  
Outcome  TimePoints 
There will be a significant difference in post-training Respectful Maternity Care (RMC) competency scores among nursing officers based on selected demographic variables such as age, years of experience, education level, and prior training exposure.  at baseline and 4th week 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   01/09/2025 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sangwansujata@gmail.com].

  6. For how long will this data be available start date provided 01-07-2026 and end date provided 01-07-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study aims to evaluate the effectiveness of Respectful Maternity Care (RMC) training in enhancing the competency of nursing officers at AIIMS Gorakhpur. It is an open-label randomized controlled trial where 44 nursing officers will be randomly assigned into experimental and control groups. The training includes webinars, simulation-based sessions, and case discussions. Competency will be assessed in domains such as knowledge, clinical and soft skills, attitude, communication, responsiveness, and respectful practice using validated tools before and after the intervention. The results will help determine the impact of structured RMC training in improving intrapartum and postnatal care. 
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