| CTRI Number |
CTRI/2025/12/098990 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the impact of a mindfulness program on emotional regulation, resilience, and academic performance in nursing students. |
|
Scientific Title of Study
|
Evaluating the Outcome of the Mindfulness Program in Promotion of Emotional Regulation, Resilience and Academic Performance in nursing students: 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 |
Sanganagouda Shanabhog |
| Designation |
Asst Professor |
| Affiliation |
KAHER,Belagavi |
| Address |
KLE Institute of Nursing Sciences, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590001
India |
| Phone |
09535453197 |
| Fax |
|
| Email |
shanabhogsangu12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Veereshkumar Nadgaon |
| Designation |
Professor and Principal |
| Affiliation |
KAHER, Belagavi |
| Address |
KLE Academy of higher education and research
Department of Mental Health Nursing, Belagavi
Belgaum
KARNATAKA
591108
India |
| Phone |
9844971345 |
| Fax |
|
| Email |
veereshnandagaon@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanganagouda Shanabhog |
| Designation |
Asst Professor |
| Affiliation |
|
| Address |
KLE Institute of Nursing Sciences, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09535453197 |
| Fax |
|
| Email |
shanabhogsangu12@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLE Academy Of Higher Education and Research Center |
| Address |
Institute of Nursing Sciences Nehru Nagar Belagavi 590010 Karnataka India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Veereshkumar Nandgaon |
KAHER INS Belagavi |
KAHER INS Nehrunagar Belagavi
Department of Mental Health
ground floor room no 02
Belgaum
KARNATAKA |
09535453197
veereshnandagaon@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Ethical Committee on Human Subjects for Ph.D. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Emotional regulation and Emotional resilience |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sudarshankriya |
is a systematic intervention program on structured meditation and breathing technique |
|
|
Inclusion Criteria
|
| Age From |
17.00 Day(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1.Nursing students aged 18–24 years. Those who are enrolled in a first year B.Sc.(N) and in selected nursing college of Belagavi district.
2.Students who are willing to participate in a mindfulness program and provide feedback.
|
|
| ExclusionCriteria |
| Details |
Young adult boys and girls who are sick at the time of data collection.
Young adults who have previously participated in a mindfulness program or have extensive experience with mindfulness practices.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is predicted that the MBI group will show significant improvements in emotional regulation, resilience, and academic performance compared to the control group at post-intervention and 6- week follow-up. These findings could provide evidence for the effectiveness of MBIs in promoting emotional well-being and academic success in young adults.
|
6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="235"
Sample Size from India="235"
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)
|
01/01/2026 |
| 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="3"
Months="0"
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response (Others) -
- 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 [shanabhogsangu12@gmail.com].
- For how long will this data be available start date provided 01-07-2027 and end date provided 01-07-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Recruitment of the sample will be done once the investigator completes the intervention |