| CTRI Number |
CTRI/2026/02/104244 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess the effectiveness of mindful and respiratory exercises through Mobile App Intervention on Mental Health, Stress and Coping Strategies among staff Nurses who working in the hospital in Mangalore |
|
Scientific Title of Study
|
A study on the Impact of Mobile App Intervention on Mental Health and Stress Coping Strategies among Nurses-A Randomized Control Trial (RCT) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shyna Noronha |
| Designation |
Nurse Manager |
| Affiliation |
Father Muller Hospital |
| Address |
Dubai Health Fertility Centre
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8792676896 |
| Fax |
|
| Email |
noronhashyna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sasikumar S |
| Designation |
Professor & HOD |
| Affiliation |
Father Muller Hospital |
| Address |
Father Muller College of Nursing
Kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9620410946 |
| Fax |
|
| Email |
sasikrisna@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sasikumar S |
| Designation |
Professor & HOD |
| Affiliation |
Father Muller Hospital |
| Address |
Father Muller College of Nursing
Kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9620410946 |
| Fax |
|
| Email |
sasikrisna@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Hospital Fr Muller road Kankanady Mangalore 575002 Karnataka India |
|
|
Primary Sponsor
|
| Name |
self funded |
| Address |
Father Muller college of nursing
Kankanady Mangalore 575002 Karnataka India |
| Type of Sponsor |
Other [Individual ] |
|
|
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 Sasikumar S |
Father Muller Hospital |
Father Muller College of Nursing Department of Medical Surgical Nursing Kankanady Mangalore 575002 Mangalore
Dakshina Kannada
KARNATAKA |
9620410946
sasikrisna@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Staff nurse |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile app intervention about breathing exercise, stress reduction mindful exercise |
Teaching breathing exercise, stress reduction mindful exercise through mobile app |
| Comparator Agent |
Not applicable |
No intervention during study period. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
willing to particiapte |
|
| ExclusionCriteria |
| Details |
Who have severe stress |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stress coping staratagies |
4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To get feedback about mobile app usage |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2026 |
| 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)
|
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 - NO
|
|
Brief Summary
|
Permission will be obtained from Intuitional Ethics committee, administrator of the hospital and concerned authorities. Will be registered in Clinical Trials Registry - India (CTRI) before recruitment Concerned form will be obtained and information sheet will be provided Screening will be done by using Perceived stress scale Samples will be selected by using simple random technique Clusters (wards/units) will be randomized into intervention and control groups. Baseline data on stress (Perceived Stress Scale-10) and coping strategies (Brief COPE inventory) will be collected. Intervention group: Receive access to the mobile app (includes stress self-monitoring, guided relaxation, mindfulness, coping tips, CBT-based modules). Control group: Continue routine institutional wellness resources. Will be receiving the app after the completion of studies Follow-up assessments will be conducted at 6 weeks and 12 weeks. To minimize contamination, randomization is at ward-level, and app access will be restricted to intervention nurses via unique login codes. |