| CTRI Number |
CTRI/2025/10/096716 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ meditation and health education] |
| Study Design |
Other |
|
Public Title of Study
|
Nurses guiding peace and health education to the heart problem patient |
|
Scientific Title of Study
|
Effectiveness of nurse led intervention on physio psychological outcomes among patients with coronary artery disease admitted in a selected tertiary care hospital at Mangaluru |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANKITA DHAR |
| Designation |
2nd year MSc nursing |
| Affiliation |
student |
| Address |
room no5 first floor medical surgical department yenepoya nursing college naringana deralakattee mangaluru
room no5 first floor medical surgical department yenepoya nursing college naringana deralakattee mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7998854959 |
| Fax |
|
| Email |
ankitadhar256@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pavithra K |
| Designation |
Assistant professor stage II |
| Affiliation |
Guide |
| Address |
Room no7 SECOND floor Nursing Foundation department yenepoya nursing college naringana deralakattee mangaluru
Room no7 SECOND floor Nursing Foundation department yenepoya nursing college naringana deralakattee mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8722095948 |
| Fax |
|
| Email |
pavithrak@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
ANKITA DHAR |
| Designation |
principal investigator |
| Affiliation |
student |
| Address |
Room no 5 first floor department of medical surgical nursing narigana deralakattee mangaluru
Room no 5 first floor department of medical surgical nursing narigana deralakattee mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7998854959 |
| Fax |
|
| Email |
ankitadhar256@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya medical college hospital |
|
|
Primary Sponsor
|
| Name |
Yenepoya Medical College Hospital |
| Address |
deralakattee Mangaluru 575018 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| yenepoya nursing college |
deralakatte mangaluru |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Noothan Lasrado |
yenepoya medical college hospital |
yenepoya university , Deralakatte second division room no 13 first floor Mangaluru department of general medicine
Dakshina Kannada
KARNATAKA |
6362132554
noothanlasrado.dns@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| yenepoya ethics committee 3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
meditation and health education |
People in the study will take part in a nurse led program that includes daily meditation and short health lessons The meditation will be done for about 20 minutes twice a day and the health lesson will be given on the first day The program will continue for 14 days during their stay in the hospital |
| Comparator Agent |
Standard hospital care routine treatment and nursing care |
Standard hospital care provided to patients with heart disease including regular medication routine monitoring and usual nursing care No additional meditation or health lesson will be given |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Aged 25-70 years
Patient admitted in general ward
Patients diagnosed with coronary artery disease includes ischemic heart disease and acute coronary syndrome
Patient able to understand and comprehend the instructions
|
|
| ExclusionCriteria |
| Details |
Patient with hearing impairment
Patient who has undergone and admitted for coronary artery bypass graft surgery
Patient who is unconscious bed ridden and confined to the bed
Patient who has psychiatric and neurological illness and on treatment
Patient who is critically ill and admitted in ICU
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effective change in physiological outcomes like blood pressure and heart rate and psychological outcomes like depression anxiety and stress will reduce in some extend |
baseline in first day will the pretest and 7th day and 14th day the outcomes will be assessed after administered of interventions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the level of adherence of patients to meditation and health education sessions
To evaluate patients satisfaction with the nurse led intervention program
To determine the association between selected demographic clinical variables age gender duration of illness lifestyle habits etc and physio psychological outcomes
To promote awareness and self management behavior related to diet exercise and medication adherence among CAD patients |
Assessed at the end of the 14-day intervention |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
11/11/2025 |
| 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="3"
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 - NO
|
|
Brief Summary
|
This study looks at how a nurse-led program that includes meditation and health education can help people with heart problems feel better and stay healthier The program will be done for 14 days in the hospital It will check changes in blood pressure heart rate and stress levels before and after the sessions The goal is to see if regular meditation and simple health lessons can improve both body and mind health in these patients |