| CTRI Number |
CTRI/2021/06/033955 [Registered on: 02/06/2021] Trial Registered Prospectively |
| Last Modified On: |
09/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Teaching ] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Agile training programme on Metacognitive ability,
Teamwork and Clinical performance among Nursing students |
|
Scientific Title of Study
|
"Effectiveness of Agile Methodology on Metacognitive ability,
teamwork and Clinical Performance among Nursing Students at Selected Colleges of Nursing Bangalore". |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suseela Thiagarajan |
| Designation |
PhD scholar |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Clinical Instructor
Room No 7
Third Floor
Department of Pediatric Nursing
College of Nursing
NIMHANS
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9972192841 |
| Fax |
|
| Email |
sushee2005@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Robert M Saldanha |
| Designation |
Professor and HOD and Guide |
| Affiliation |
YENEPOYA Medical College and Hospital |
| Address |
Room no 10
First Floor
Department of Pediatrics
YENEPOYA Medical College and Hospital
YENOPOYA Deemed to be University
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845081567 |
| Fax |
|
| Email |
saldanha.drprakash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suseela Thiagarajan |
| Designation |
PhD scholar |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Clinical Instructor
Room No 7
Third Floor
Department of Pediatric Nursing
College of Nursing
NIMHANS
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9972192841 |
| Fax |
|
| Email |
sushee2005@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| College of Nursing NIMHANS Bangalore |
| Kempegowda College of Nursing Bangalore |
|
|
Primary Sponsor
|
| Name |
Suseela Thiagarajan |
| Address |
Clinical Instructor
College of nursing
Nimhans
Bangalore
560029
|
| 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 |
| Suseela Thiyagarajan |
NIMHANS |
Department of Pediatric Nursing
Room No 3 First Floor
College of nursing
NIMHANS Bangalore 560029
Bangalore
KARNATAKA |
9972192841
sushee2005@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics Committe (Behavioral Science Division) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy fourth year BSc nursing students of selected colleges of Nursing |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agile training programme |
After the pre-test the nursing students will be sensitized with agile methodology using video assisted teaching followed by role play. The student team will be selected based on the pre-test scores of metacognitive ability, clinical performance through OSCE assessment, and scholastic performance of the previous year. The team leader will be selected based on the pre-test scores of leader attribute inventory. Specific training will be given to the team leaders about their roles and responsibilities. The student team will be consisting of eight members including one team leader. Total of 8-9 teams will be formed. Basic neonatology will be taught using agile methodology for 21 days. The course objectives and evaluation methods will be designed by the researcher/ facilitator. The topics for basic neonatology will be new-born examination, neonatal care, neonatal immunization, new-born feeding and neonatal resuscitation and will be chosen based on the student’s opinion. Each week two topics will be chosen with the duration of 6 days. The day one itself selected topics will be subdivided in to smaller topics and will be shared to each individual student (2 hours). The pre-validated module will be given to the students and video link on selected clinical procedure will be shared to the students. The student team will complete the task every day. If any problem in the learning pattern the team leader will inform to the researcher/facilitator. Team leader will not have any control over the student team. She/he will be continuously motivating the student to complete the objectives. The team leader will be recording all the activities will be happening within the said duration of time and same will be reported to the researcher. From day 2-6 each individual student will be spending the time for 15-20 min for completing the task, but as a student team they will be spending for 1 hour 10 min along with the team leader and daily meeting will be conducted for 15 min in order to identify the progress of learning. 7th day students will demonstrate any one of the procedure or submit the assignment or participating quiz from the chosen topics (each team will get 15 min) (Review meeting). The subject experts and researcher will give the feedback to the student team followed by student team alone will discuss the problems faced and solved (15min) for the particular week is called Retrospective meeting). This pattern of active learning will be continued for the subsequent weeks also. |
| Comparator Agent |
No intervention |
The intervention will not be given after the pre-test, but will be given after the post-test 2 for 10 days as a ethical consideration. Only one topic will be chosen and it will be taught using agile methodology. Two days of agile training followed by team leader selection. 3-9 days topic division and all activities carried out as intervention. On 10th day agile opinion questionnaire will be administered to the students for assessing the perception. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
All the fourth-year B.sc nursing students will be included from the selected colleges |
|
| ExclusionCriteria |
| Details |
Those students who are absent at the time of the initial survey and intervention will be excluded.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the learning pattern by improved metacognitive ability, competency in performing the procedures, improved teamwork and self-satisfaction towards agile methodology(opinion). |
Six Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Promote the students as Self -directed learners/lifelong learners with time management. |
Six Months |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
15/06/2021 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Today, students are tech-savvy. Students are becoming an active learner, and more interested in activity curriculum. Agile method is an adoptive, iterative, incremental, and people oriented. Core values of agile are collaboration, team work, and self-learning, and communication, reflection as metacognitive ability, interpersonal relationships, and adaptation to change. Nursing students those who are undergoing agile training will have improved in their metacognitive ability, teamwork and clinical performances (when compared to before and also to college with nursing students not receiving such intervention). The agile training programme would be an intervention package to educate the nursing students on basic neonatology for 21 days. The topics are neonatal care, new-born examination, new-born feeding, new-born immunization and neonatal resuscitation. Basic knowledge and skills of above-mentioned topics will be assessed through OSCE (objective structured clinical examination) as a baseline and soon after the intervention post-test 1 and followed by post 2 will be conducted with the interval of 7 days. The control arm will not receive the intervention up to post-test 2 in order to check the efficacy of the methodology. Due to ethical consideration the control group will be taught about the agile methodology for selected topics with the duration of 10 days (sensitization with training) |