| CTRI Number |
CTRI/2025/11/097018 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Interventional Trial] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to find out how nurse led care helps improve breathing and health in patients with COPD admitted to a hospital in Mangalore |
|
Scientific Title of Study
|
Effectiveness of nurse-led intervention on physiological parameters among patients with COPD admitted in a selected 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 |
Deepashree T |
| Designation |
PG student |
| Affiliation |
Yenepoya Nursing college |
| Address |
postgraduate in the Department of Medical Surgical Nursing, Naringana, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8073551869 |
| Fax |
|
| Email |
deepavgm322@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anju Ullas |
| Designation |
Associate Professor |
| Affiliation |
Yenepoya Nursing college |
| Address |
Department of Medical Surgical Nursing, Yenepoya Nursing College, Naringana, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7892266459 |
| Fax |
|
| Email |
anjuullas@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Deepashree T |
| Designation |
PG student |
| Affiliation |
Yenepoya Nursing college |
| Address |
Postgraduate in the Departmenet of Medical Surgical Nursing, Yenepoya Nursing College, Naringana, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8073551869 |
| Fax |
|
| Email |
deepavgm322@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital |
|
|
Primary Sponsor
|
| Name |
Deepashree T |
| Address |
Yenepoya Nursing College, Yenepoya (Deemed to be University), Deralakatte, Mangaluru – 575018, Karnataka, India |
| Type of Sponsor |
Other [self funding] |
|
|
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 |
| Deepashree T |
Respiatory Medicine ward |
Yenepoya Medical College Hospital,
Yenepoya Deemed to be University, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
8073551869
deepavgm322@gmail.com |
|
|
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: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse led Intervention on Physiological parameters among COPD Patients |
Pursed lip breathing exercise (5-10 min/session; 3 times dai ly), Abdominal breathing exercise (5-10 min/session; 3 times daily), Incentive spirometry exercise and Health education (on day 1 which includes lifestyle modifications, symptom recognition, medication adherence, and preventive aspects). These breathing exercises will be administered for 5 days/week for 2 weeks. |
| Comparator Agent |
Routine Hospital care |
Participants in the control group will receive routine hospital care and standard medical management as prescribed by the physician. NO Nurse led intervention will be provided |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient diagnosed with COPD with the age group of 30 years to 60 years
2 patient diagnosed with COPD who are able to do breathing Exercises
3 patient with COPD who are able to read English Kannada Malayalam |
|
| ExclusionCriteria |
| Details |
Patients meeting any of the following conditions will be excluded from the study
1 Requires intubation, ventilatory support or intensive care
2 Has undergone major lung or heart surgery
3 Unable to comply with the intervention due to cognitive or physical limitations
4 Enrolled in similar or the other Complimentary interventional studies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of nurse-led intervention on physiological parameters (blood pressure, respiratory rate, dyspnoea, oxygen saturation, and pulse rate) among COPD patients |
Data will be collected at two points — before the intervention (baseline) and after completion of 2 weeks of nurse-led intervention (post-test) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Improvement in dyspnoea level among COPD patients following nurse-led intervention
2 Improvement in patient comfort and relaxation after nurse-led intervention
3 Association between selected demographic variables (age, gender, duration of illness, smoking history, etc.) and physiological parameters of COPD patients |
Data will be collected at two points — before the intervention (baseline) and after completion of 2 weeks of nurse-led intervention (post-test). |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/11/2025 |
| 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="1"
Months="10"
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
|
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder characterized by airflow limitation, dyspnea, and decreased oxygenation, which significantly affects the patient’s quality of life. Nurse-led interventions focusing on patient education, breathing exercises, and monitoring of physiological parameters can help improve patient outcomes.
The present study aims to evaluate the effectiveness of a nurse-led intervention on physiological parameters such as blood pressure, respiratory rate, oxygen saturation, pulse rate, and dyspnea level among COPD patients admitted in a selected hospital in Mangaluru.
A quasi-experimental, non-randomized, active control, pre-test and post-test design will be used. The intervention group will receive structured nurse-led care including breathing exercises (pursed-lip breathing), health education, and counseling for self-care, while the control group will receive routine hospital care. Data will be collected using standardized instruments before and after the intervention. The findings are expected to show improvement in physiological parameters, thereby emphasizing the importance of nurse-led interventions in COPD management. |