| CTRI Number |
CTRI/2018/11/016256 [Registered on: 02/11/2018] Trial Registered Prospectively |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ice bag application to reduce pain] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to assess the effect of Ice application on Pain in sheath removal among patients undergoing coronary angiography in a cardiac thoracic speciality hospital.
|
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Scientific Title of Study
|
A Randomized Control Trial to assess the efficacy of Ice Bag application on femoral sheath removal pain among patients undergoing coronary angiography in a tertiary care hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maj Hemalatha G L |
| Designation |
PG (Nursg)Trainee officer |
| Affiliation |
Armed Forces Medical College |
| Address |
MSc Nursing II year
Medical Surgical Nursing (Department)
College of Nursing
Armed Forces Medical College
Wanowarie
Pune
MAHARASHTRA
411040
India |
| Phone |
8975304010 |
| Fax |
|
| Email |
hema.gloganathan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lt Col S Gita |
| Designation |
professor & Guide |
| Affiliation |
Armed Forces Medical College |
| Address |
Head of the Department
Department of Medical Surgical Nursing
College of Nursing
Armed Forces Medical College
Wanowarie
Pune
MAHARASHTRA
411040
India |
| Phone |
9910998014 |
| Fax |
|
| Email |
sgita66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maj Hemalatha G L |
| Designation |
PG (Nursg)Trainee officer |
| Affiliation |
Armed Forces Medical College |
| Address |
MSc Nursing II year
Department of Medical Surgical Nursing
College of Nursing
Armed Forces Medical College
Wanowarie
Pune
MAHARASHTRA
411040
India |
| Phone |
8975304010 |
| Fax |
|
| Email |
hema.gloganathan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Military Hospital cardio thoracic center- pune |
|
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Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Hemalatha G L |
MH (CTC) |
Military Hospital
cardio thoracic centre
Old golibar Maidan
Camp
Pune
MAHARASHTRA |
8975304010
hema.gloganathan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical research Cell &institutional Ethical committee AFMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I252||Old myocardial infarction, (2) ICD-10 Condition: I237||Postinfarction angina, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ice Bag application on Femoral sheath removal Pain |
The researcher monitors hemodynamic parameters once its stable the researcher uses Ice bag application of 15 mts for experimental group. The femoral sheath will be removed by the researcher and allows the blinded investigator to measure the pain
|
| Comparator Agent |
Standard Care ( with out Ice bag application) on femoral sheath removal Pain |
The researcher monitors hemodynamic parameters once its stable the researcher removes the femoral sheath without Ice Bag application in control group . Researcher allows the blinded investigator to measure the pain .
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.coronary angiography through femoral site
2.Age20 years to 80 years
3.Able to speak and understand Hindi and English
4.Stable hemodynamic parameter
|
|
| ExclusionCriteria |
| Details |
1.Allergy to cold application
2.Patients who undergo coronary angiography through radial site
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Primary objective:
To assess the efficacy of ice bag application in comparison with standard therapy on femoral sheath removal pain among patients undergoing coronary angiography
|
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objective:
To assess the efficacy of ice bag application in comparison with standard therapy on Post femoral sheath removal complications among patients undergoing coronary angiography
|
18 Months |
|
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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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/11/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
PG Thesis for completion of degree purposes only. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
In this study the researcher will study the efficacy of Ice bag application on femoral sheath removal pain and post femoral sheath removal complication.The researcher will use single blinding to minimize the confounding variables. The trained investigator will be blinded regarding intervention group.once willingness obtained the patients will be randomoised by computer allocation method in two group such as experimental and control group. The researcher monitors hemodynamic parameters once its stable the researcher use standard care without ice bag application for the control group, ice bag application of 15 mts to the experimental group.The femoral sheath will be removed by the researcher and allows the blinded investigator to measure the pain by NRS followed by patient will be assessed and monitored for post femoral sheath removal complication ( Bleeding/Hematoma/Ecchymosis).
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