| CTRI Number |
CTRI/2026/03/105819 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ISBAR communication Tool] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A study to evaluate the effect of a structured handover communication training program on clinical decision-making and practice among nurse interns |
|
Scientific Title of Study
|
Effectiveness of ISBAR handover protocol training on clinical acumen among nurse at interns at selected colleges of himachal pradesh |
| 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 Maga Pira |
| Designation |
Post graduate resident |
| Affiliation |
Akal College of Nursing Baru Sahib |
| Address |
Medical surgical nursing (Cardiothoracic and vascular nursing)
Akal College of Nursing Eternal University Baru Sahib 173101 Himachal Pradesh
Medical surgical nursing (Cardiothoracic and vascular nursing)
Akal College of Nursing Eternal University Baru Sahib 173101 Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173101
India |
| Phone |
7497087066 |
| Fax |
|
| Email |
piramaga22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. Babita Kumari |
| Designation |
Associate Professor |
| Affiliation |
Akal College of Nursing Baru Sahib |
| Address |
Medical surgical nursing (Cardiothoracic and vascular nursing)
Akal College of Nursing Eternal University Baru Sahib 173101 Himachal Pradesh
Medical surgical nursing (Cardiothoracic and vascular nursing)
Akal College of Nursing Eternal University Baru Sahib 173101 Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173101
India |
| Phone |
8580855352 |
| Fax |
|
| Email |
vishalbabita90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Maga Pira |
| Designation |
Post graduate resident |
| Affiliation |
Akal College of Nursing Baru Sahib |
| Address |
Medical surgical nursing (Cardiothoracic and vascular nursing)
Akal College of Nursing Eternal University Baru Sahib 173101 Himachal Pradesh
Medical surgical nursing (Cardiothoracic and vascular nursing)
Akal College of Nursing Eternal University Baru Sahib 173101 Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173101
India |
| Phone |
7497087066 |
| Fax |
|
| Email |
piramaga22@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ms Maga Pira |
| Address |
Akal College of Nursing Eternal University Baru Sahib 173101 Himachal Pradesh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Chaudhary |
Akal College of Nursing Baru Sahib |
Medical surgical nursing (Cardiothoracic and vascular nursing)
Akal College of Nursing Baru Sahib Eternal University
Sirmaur
HIMACHAL PRADESH |
9805077103
ruchi.devine232@gmail.com |
| Dr Sunita Verma |
Maharishi Markandeshwar Nursing College |
Medical Surgical Nursing
Maharishi Markandeshwar Nursing College, Kumarhatti
Solan
HIMACHAL PRADESH |
7018416437
principal.mmcon@mmusolan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Akal Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
BSc Nursing students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ISBAR handover protocol training |
On the 1st day, a pre-test will be taken. And, on the 2nd day ISBAR handover protocol training will be given to the experimental group. On the 3rd day a post-test will be taken |
| Comparator Agent |
No intervention will be given to the control group |
On the 1st day, a pre-test will be conducted and on the 3rd day, a post-test will be taken |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Nurse interns who will be available at the time of data collection and willing to participate in the study
2.Both genders
|
|
| ExclusionCriteria |
| Details |
•Those who will have a hand injury and won’t be able to write |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| nurse interns will have adequate knowledge regarding ISBAR handover |
1 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/03/2026 |
| 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="1"
Months="0"
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 - YES
- 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).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gracymaga@gmail.com].
- For how long will this data be available start date provided 23-09-2026 and end date provided 23-05-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Phase I:
- On
the first day, consent will be taken from the Principal of selected colleges
of Himachal Pradesh
- A
purposive sampling technique will be used to choose the sample.
- Data
collection began with a pre-test utilising a structured questionnaire and a
vignette based question for both the control and experimental groups to
assess participants existing knowledge and decision making skills
regarding ISBAR handover. Knowledge will be evaluated using a structured
questionnaire, while decision making will be measured using a vignette
based assessment tool consisting of written case scenarios. On the second
day, theoretical training regarding ISBAR handover protocol will be delivered
through a lecture only to the experimental group to allow the learners to gain
knowledge and critical handover skills of ISBAR principle.
Phase II
|