| CTRI Number |
CTRI/2025/05/086459 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [active breathing cycle technique and comrehensive counseling program] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
"A Study on the Lived Experiences and Effectiveness of Selected Nursing Interventions on Breathing Efficiency in COPD Patients at GIMS Hospital, Gadag" |
|
Scientific Title of Study
|
Lived Experiences and the Impact of Selected Nursing Interventions on Breathing Efficacy Among Patients with Chronic Obstructive Pulmonary Disease at Gadag institute of medical sciences Hospital, Gadag |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTRI/2023/11/060264 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Rekha KB |
| Designation |
Associate professor |
| Affiliation |
GIMS Government colloge of nursing Gadag |
| Address |
Department of medical surgical nursing
GIMS Government college of nursing Gadag
Mallasamudra Gadag
Department of medical surgical nursing
GIMS Government college of nursing Gadag
Mallasamudra Gadag
Gadag
KARNATAKA
582103
India |
| Phone |
918147676187 |
| Fax |
|
| Email |
rekhakb60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shivangouda V M |
| Designation |
Professor |
| Affiliation |
GIMS Government colloge of nursing Gadag |
| Address |
GIMS Government college of nursing Gadag
Mallasamudra Gadag
GIMS Government college of nursing Gadag
Mallasamudra Gadag
Gadag
KARNATAKA
582103
India |
| Phone |
919964287187 |
| Fax |
|
| Email |
smiagb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Rekha KB |
| Designation |
Associate professor |
| Affiliation |
GIMS Government colloge of nursing Gadag |
| Address |
Department of medical surgical nursing
GIMS Government college of nursing Gadag
Mallasamudra Gadag
Department of medical surgical nursing
GIMS Government college of nursing Gadag
Mallasamudra Gadag
Gadag
KARNATAKA
582103
India |
| Phone |
918147676187 |
| Fax |
|
| Email |
rekhakb60@gmail.com |
|
|
Source of Monetary or Material Support
|
| GIMS hospital Gadag.
Institute provide the COPD patients and for them standard patient care according to the protocal |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Self funded |
| Type of Sponsor |
Other [self funded as it is a Ph.D study ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
SELF FUNDED |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rekha KB |
Gadag institute of medical science hospital male and female medicine wards and MICU |
Mallasamudra Gadag Pin 582103
Gadag
KARNATAKA |
8147676187
rekhakb60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gadag institute of medical sciences institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Active cycle breathing technique
2.Comprehensive counseling technique |
Active cycle breathing technique is modified breathing exercise comprising of 6 steps each step 30 to 40 seconds required and each cycle will complete 3 to 4 minute and the patient need 30 minutes or around 10 cycles of ACBT
Step 1:conscious deep breathing 3 to 4 times
step 2 :thoracic chest expansion or diaphragmatic breathing
step 3:conscious deep breathing 3 to 4 times
step 4 :repetition of thoracic chest expansion or diaphragmatic breathing
Step 5:conscious deep breathing 3 to 4 times
step 6: 1 to 2 huff cuff expectoration of mucus secretions with help of pillow support on anterior chest |
| Intervention |
2.Comprehensive counseling program |
Comprehensive counseling program with this intervention clients will get 3 counseling sessions regarding
1. Quitting smoking
2.Avoiding active and passive smoking
3.Avoiding triggering or aggravating factors like dust /biomass /pollution
comprehensive counseling program will be prepared based on qualitative study findings |
| Comparator Agent |
standard care |
as per the hospital policy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with COPD between the age group of 18 years to 60 years.
2.The patients with COPD who are willing to participate in the study.
3.Patients with COPD SPO2 having value range 90% and above.
4.Patients with COPD who can follow and understand the instructions in kannada and english
|
|
| ExclusionCriteria |
| Details |
1.Patients with COPD and Severe Cognitive Impairment: Patients with dementia, delirium, or other cognitive impairments affecting communication and understanding.
2.Patients with COPD Other Major Respiratory Illnesses: Patients diagnosed with asthma, tuberculosis, lung cancer, or interstitial lung disease along with COPD.
3.Patients with COPD Critically Ill Patients: Patients who are critically ill or in intensive care units (ICUs).
4.Patients with COPD Recent Thoracic Surgery: Patients who have undergone major thoracic or abdominal surgery in the last 3 months.
5.Patients with COPD Unwilling to Participate: Patients who refuse to give informed consent or do not wish to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Implementation of targeted nursing interventions is anticipated to positively influence the clinical and psychological well-being of COPD patients, empowering them to take an active role in their treatment and self-care, ultimately contributing to improved health outcomes and quality of life. |
Implementation of targeted nursing interventions is anticipated to produce measurable improvements in the clinical and psychological well-being of COPD patients by the end of the intervention period (e.g., 4 weeks), with sustained effects observed during follow-up assessments at 8 and 12 weeks. These improvements are expected to empower patients to engage more actively in their treatment and self-care, contributing to long-term enhancements in health outcomes and quality of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oselected nursing interventions will be effective and enhance the clinical psychological parameters of patients suffering with COPD and empower to participate more effectively in the treatment and self care |
12 months |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/09/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 (Others) - De-identified individual participant data (IPD) related to demographic details, baseline characteristics, intervention details, outcome measures (breathing efficacy scores), and follow-up data.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - The data will be available upon reasonable request by contacting the principal investigator at the institution or via institutional data repository.
- For how long will this data be available start date provided 01-06-2028 and end date provided 01-06-2032?
Response (Others) - data will be available beginning 6 months after publication of the main study results and will be accessible for 5 years thereafter.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - restricted access option instead (e.g., sharing only with researchers under certain conditions)
|
|
Brief Summary
|
selected nursing interventions will be effective and enhance the clinical psychological parameters of patients suffering with COPD and empower to participate more effectively in the treatment and self care
|