Back Pain Clinical Trial
Official title:
Effect of Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications
Verified date | July 2022 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aimed to assess the effect of position change and back massage versus early ambulation on post transfemoral coronary angiography complications.
Status | Completed |
Enrollment | 185 |
Est. completion date | August 1, 2018 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Mean arterial blood pressure =70 mmHg. - Heart rate = 60 b/m. - Manual compression closure technique on the access site - Partial thromboplastin time < 90 seconds. - Prothrombin time <16 seconds). - No anticoagulant therapy within 24 hours before the cardiac catheterization procedure. Exclusion Criteria: - Patients who had a history of previous coronary stents. - chronic pain, - chronic obstructive pulmonary disease. - Renal failure, - Hypercoagulable conditions such as protein C. - Cardiopulmonary resuscitation during angiography. - Femoral artery ruptures during angiography. - Chest pain with new electrocardiograph change. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
Kim K, Won S, Kim J, Lee E, Kim K, Park S. Meta-analysis of complication as a risk factor for early ambulation after percutaneous coronary intervention. Eur J Cardiovasc Nurs. 2013 Oct;12(5):429-36. doi: 10.1177/1474515112462519. Epub 2012 Oct 17. Review. — View Citation
Lau KW, Tan A, Koh TH, Koo CC, Quek S, Ng A, Johan A. Early ambulation following diagnostic 7-French cardiac catheterization: a prospective randomized trial. Cathet Cardiovasc Diagn. 1993 Jan;28(1):34-8. — View Citation
Steffenino G, Dellavalle A, Ribichini F, Russo P, Conte L, Dutto S, Giachello G, Lice G, Tomatis M, Uslenghi E. Ambulation three hours after elective cardiac catheterisation through the femoral artery. Heart. 1996 May;75(5):477-80. — View Citation
Wood RA, Lewis BK, Harber DR, Kovack PJ, Bates ER, Stomel RJ. Early ambulation following 6 French diagnostic left heart catheterization: a prospective randomized trial. Cathet Cardiovasc Diagn. 1997 Sep;42(1):8-10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oozing and bleeding scale | It was designed to measure any leakage of blood from the puncture site. It classified oozing and bleeding according to the surface area of the dressing soaked with blood to three items: (1) No bleeding or oozing (dry dressing), (2) Oozing (surface area < 2cm 2), (3) Bleeding (surface area =2cm 2).
The researcher rated vascular complications on a dichotomous scale (Yes/No). The "Yes" response indicated the presence of complications and was given a score of one. On the other hand, the "No" response indicated the absence of complications and received a score of zero. |
After six hours post transfemoral coronary angiography | |
Primary | Ecchymosis and hematoma formation scale | It was designed to measure ecchymosis and hematoma size. It classified ecchymosis and hematoma according to the surface area of blood collection under the skin into three items: (1) No ecchymosis or hematoma (no blood collection), (2) Ecchymosis (surface area <2cm2), (3) Hematoma (surface area = 2cm2). The researcher rated vascular complications on a dichotomous scale (Yes/No). The "Yes" response indicated the presence of complications and was given a score of one. On the other hand, the "No" response indicated the absence of complications and received a score of zero. | After six hours post transfemoral coronary angiography | |
Primary | Numeric rating scale | The scale was used to assess the lower back pain intensity. It is a four-point numerical rating scale: no pain (0), mild pain (1-3), moderate pain (4-7), severe pain (8-10). | After six hours post transfemoral coronary angiography |
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