| CTRI Number |
CTRI/2019/09/021344 [Registered on: 19/09/2019] Trial Registered Prospectively |
| Last Modified On: |
18/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of video taped versus simulation based instruction regarding Neonatal Resuscitation among Nursing Students at AIIMS Rishikesh, Uttarakhand. |
|
Scientific Title of Study
|
A Randomized Controlled Trial to assess effectiveness of video taped versus simulation based instruction on knowledge and skills regarding Neonatal Resuscitation among Nursing Students at AIIMS Rishikesh, Uttarakhand. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Indu Bala |
| Designation |
M.Sc. Nursing 2nd year |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
College of Nursing, All India Institute Of Medical Sciences, Virbhadra Marg, Pashulok, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9560118407 |
| Fax |
|
| Email |
insan2905059@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Rupinder Deol |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Mrs. Rupinder Deol
Assistant Professor, College of Nursing,
All India Institute of Medical Sciences (AIIMS) Rishikesh Uttarakhand 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7055074477 |
| Fax |
|
| Email |
rupinder.nur@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Rupinder Deol |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Mrs. Rupinder Deol
Assistant Professor, College of Nursing,
All India Institute of Medical Sciences (AIIMS) Rishikesh Uttarakhand 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7055074477 |
| Fax |
|
| Email |
rupinder.nur@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indu Bala |
| Address |
Room Number 359, Girls Hostel- 2, virbhadra marg, pashulok AIIMS Rishikesh uttarakhand 249203 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 |
| Indu Bala |
College of Nursing, All India Institute of Medical Sciences |
Virbhadra Marg, Pashulok, Rishikesh- 249203
Dehradun
UTTARANCHAL |
9560118407
insan2905059@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Rishikesh (Uttarakhand) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Effectiveness of two teaching modalities in terms of knowledge and skills among healthy & volunteer B.Sc. Nursing students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Basic knowledge lecture followed by Simulation-based instruction on Neonatal Resuscitation |
1 Hour Basic knowledge lecture on Neonatal Resuscitation followed by 20-30 minutes skill demonstration on Neonatal Resuscitation using simulators to Arm-2 |
| Intervention |
Basic knowledge lecture followed by Video-based instruction on Neonatal Resuscitation. |
1 Hour Basic knowledge lecture on Neonatal Resuscitation followed by showing 20-30 minutes Video on Neonatal Resuscitation to Arm- 1. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
B.Sc. Nursing 2nd & 3rd-year students who will give consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
B.Sc. Nursing 2nd & 3rd-year students who have been already exposed to Neonatal Resuscitation in any form e.g. teaching, any previous course/ workshop. |
|
|
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 |
| Post intervention knowledge level will be assessed by taking post test using structured knowledge questionnaire same as pretest. Post intervention skills will be assessed by taking Re-Demonstration on simulators at different OSCE (Objective Structured Clinical Examination) Stations using structured procedure check list on Neonatal Resuscitation. |
Post intervention knowledge
and skills will be assessed once, just after giving the intervention (November 2019) Over all analysis of the study will be done by June,2020. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pre intervention knowledge level will be assessed by taking pre test using structured knowledge questionnaire. Pre intervention skills will be assessed by taking Demonstration on simulators at different OSCE (Objective Structured Clinical Examination) Stations using structured procedure check list on Neonatal Resuscitation. |
Pre intervention knowledge
and skills will be assessed once, just before giving the intervention (November 2019) Over all analysis of the results will be done by June,2020 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/10/2019 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, single-blinded, parallel-group trial, comparing the effectiveness of videotaped versus simulation-based instruction on knowledge and skills regarding Neonatal Resuscitation among B.Sc. Nursing 2nd and 3rd year students of AIIMS, Rishikesh, Uttarakhand. Post-intervention knowledge and skills will be evaluated on the same day after providing the intervention. The primary outcome measure will be evaluation of the effectiveness of two teaching modalities - Video-based versus Simulation-based instruction in terms of knowledge and skills. |