| CTRI Number |
CTRI/2025/05/087986 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the effectiveness of nurse led package for transradial access site management in heart patients undergoing angioplasty. |
|
Scientific Title of Study
|
A randomized controlled trial to assess the effectiveness of nurse-led intervention package on transradial access site care for patients undergoing percutaneous coronary intervention on selected outcome variables admitted in cardiology units, Advanced Cardiac Centre, PGIMER, Chandigarh, 2024-26. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Damini |
| Designation |
MSc. Nursing Student |
| Affiliation |
National Institute of nursing education , PGIMER , Chandigarh |
| Address |
Room no:208,Department Of National Institute of nursing education , PGIMER ,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8383924350 |
| Fax |
|
| Email |
dhimandamini224@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neena Vir Singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of nursing education , PGIMER , Chandigarh |
| Address |
Room no: 212, Department of National Institute of nursing education , PGIMER , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8146552482 |
| Fax |
|
| Email |
neenasingh_2@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Monika Dutta |
| Designation |
Associate Professor |
| Affiliation |
National Institute of nursing education , PGIMER , Chandigarh |
| Address |
Room no: 120, Department of National Institute of nursing education , PGIMER , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872528465 |
| Fax |
|
| Email |
monika.dutta75@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Damini |
| Address |
Room no:208, Department of National Institute of nursing education , PGIMER , Chandigarh |
| 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 |
| Neena Vir Singh |
Advance cardiac centre |
Cardiology ward,PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
8146552482
neenasingh_2@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Chandigarh Institutional ethics committee (intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nurse-led intervention package on transradial access site care |
Eduaction regarding funtioning of heart Post procedural pain mangement Education regarding recognotion of vascular complications
|
| Comparator Agent |
Routine care |
Pre procedural praparation , Post procedural pain mangement, health education
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients equal or more than 18 year
2 Both male and female willing to participate
3 Able to understand hindi english and punjabi language |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| vascular complications and Pain |
At baseline, immediate+ within 24 hours+ at discharge, at two weeks after PCI. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge |
Immediate
Within 24 hours
At discharge
At two weeks
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/06/2025 |
| 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 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
|
A randomized controlled trial to assess the effectiveness of the "nurse-led
intervention package on transradial access site care" for patients
undergoing percutaneous coronary intervention on selected outcome variables admitted in
cardiology units, Advanced Cardiac Centre, PGIMER, Chandigarh, 2024-26. A total of 100 adult patients will be enrolled and randomized equally into control and experimental groups. The intervention group will receive a structured nurse-led care package focusing on education, complication prevention, pain management, activity guidelines, and follow-up care post-PCI via the transradial route, while the control group will receive routine care. Outcome variables include incidence of vascular complications (bleeding, ecchymosis, hematoma), pain level, comfort, knowledge, and hypoesthesia. The study is expected to provide evidence for the effectiveness of nurse-led interventions in improving clinical and patient-reported outcomes post-transradial PCI.
|