| CTRI Number |
CTRI/2024/12/078630 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing effectiveness of Two Teaching Methods(simulation- real life scenario and traditional) for Helping Healthcare Workers Deliver Bad News to Patients at AIIMS Gorakhpur |
|
Scientific Title of Study
|
A study to assess the effectiveness of Breaking Bad News Standardized Participant Intervention among Health care teams level of confidence and communication skills at 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 |
Ankita |
| Designation |
2nd Year MSc Nursing Student |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,Gorakhpur |
| Address |
Department of Psychiatry Nursing,College of Nursing,AIIMS Gorakhpur,kunraghat ,Gorakhpur, Uttar Pradesh
Department of Psychiatry Nursing, College Of Nursing,AIIMS Gorakhpur,Kunraghat, Gorakhpur,Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9560655235 |
| Fax |
|
| Email |
13ankita99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Arun Varghese |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,Gorakhpur |
| Address |
Department of Psychiatry Nursing,College of Nursing, AIIMS Gorakhpur,kunraghat,Gorakhpur Uttar Pradesh 273008
Department of Psychiatry Nursing,College of Nursing,AIIMS Gorakhpur,Kunraghat, Gorakhpur,Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8194009109 |
| Fax |
|
| Email |
arunvarghese.msc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankita |
| Designation |
2nd Year MSc Nursing Student |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,Gorakhpur |
| Address |
Department of Psychiatry Nursing,College of Nursing, AIIMS Gorakhpur,kunraghat,Gorakhpur, Uttar Pradesh 273008
Department of Psychiatry Nursing,College of Nursing,AIIMS Gorakhpur,Kunraghat, Gorakhpur,Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9560655235 |
| Fax |
|
| Email |
13ankita99@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 |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Mr Arun Varghese |
AIIMS Gorakhpur |
4th floor,College of Nursing,MNC building , Gorakhpur,Uttar Pradesh
Gorakhpur
UTTAR PRADESH |
8194009109
arunvarghese.msc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committe ALL India Institute of Medical Sciences,Gorakhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nurses,Junior Residents and Senior Residents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Simulation Based Education |
Simulation based training program among nurses,junior residents and senior residents to asssess the effectiveness of Breaking the Bad News Module.Participants will be recruited for the study and informed consent will be taken.Random allocation of participants will be done with a computer generated list.Simulation based training program will be provided to the participants in the experimental group and Routine teaching will be provided to the participants in the control group via lecture cum discussion method. The Simulation Program includes the following schedule:Phase I : Welcoming and Briefing Phase II: Pre course assessment on knowledge,skill and confidence level before the simulation based training.Phase III:Simulation session on breaking the bad news will be done using the scenarios.Phase IV:Post test to assess knowledge,skills and confidence level will be assessed on the same day and follow up will be done after 4 weeks of the simulation training program |
| Comparator Agent |
Traditional (Lecture cum discussion) Method of teaching |
Traditional teaching (lecture cum discussion)
Details:Method of teaching:Lecture cum discussion
Presentation Topics:Related to effectiveness of Breaking the Bad news module
Duration : In 4 weeks
Participants: Nursing officers, Junior residents and Senior resdidents working in critical area of AIIMS Gorakhpur |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Junior Residents, Senior Residents and Nurses who are working in ICU,Trauma and Emergency and are available during study at AIIMS Gorakhpur |
|
| ExclusionCriteria |
| Details |
Nursing Officers, Junior Residents and Senior Residents who are already exposed to Breaking the Bad News |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be an improvement in level of knowledge,skill and confidence after simulation based training program among nurses,junior residents and senior residents |
Baseline,4 weeks,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be a significant difference between knowledge,skill and confidence with the selected demographic variables. |
at baseline and 4th week |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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 4 |
|
Date of First Enrollment (India)
|
07/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
A study to assess the effectiveness of Breaking Bad News Standardized Participant Intervention among Health care team’s level of confidence and communication skills at AIIMS Gorakhpur- A Randomized Control Trial. After collecting the demographic data, all the samples that fulfil the criteria will be randomized into the experimental group (simulation teaching) and the control group (routine teaching). After which they will undergo the pre knowledge, skills, and confidence levels assessment. The experimental group will be given simulation-based training on Breaking the Bad News, while the control group will be provided with routine teaching on Breaking the Bad News via lecture cum discussion method. Both group’s post-test knowledge, skills, and confidence levels will be assessed on the same day and follow-up will be done after one month. At the end of the study, the researcher will ensure that both the Experimental and control groups are exposed to both interventions for ethical reasons |