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.

Phase 1/2

Not yet recruiting

• Conditions: Old myocardial infarction, (2) ICD-10 Condition: I237||Postinfarction angina,

• Registration Number: CTRI/2018/11/016256

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).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-11-13
• Study Start: 2018-11-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

1.Allergy to cold application 2.Patients who undergo coronary angiography through radial site.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective:	18 months
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MH (CTC); 🇮🇳 Pune, MAHARASHTRA, India

MH (CTC)

🇮🇳Pune, MAHARASHTRA, India

Hemalatha G L

Principal investigator

8975304010

hema.gloganathan@gmail.com