Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications

Back Pain Clinical Trial

Official title:

Effect of Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05446987
• Other study ID #: Transfemoral Complication
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: July 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aimed to assess the effect of position change and back massage versus early ambulation on post transfemoral coronary angiography complications.

Description:

Post transfemoral coronary angiography (TFCA) may be associated with complications such as oozing, bleeding, ecchymosis, hematoma, and back pain. As a result, nursing practice must be geared toward enhancing patient safety post-transfemoral coronary angiography procedure. This study aimed to assess the effect of position change and back massage versus early ambulation on post transfemoral coronary angiography complications. A quasi-experimental research design was used to conduct this study at the Coronary Care Unit of the selected university hospital in Egypt. A convenience sample of 185 patients undergoing transfemoral coronary angiography was included in the study during the first 6 hours post-transfemoral coronary angiography and randomly assigned to two groups: 92 patients received position change and back massage (PCBM group), and 93 patients underwent early ambulation after the first 3 hours post-transfemoral coronary angiography (EA group). The used tool was "Post Transfemoral Coronary Angiography Complication Assessment".

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Ambulation Difficulty
• Back Pain
• Bleeding
• Catheter Complications
• Hematoma
• Mobility Limitation

Intervention

Other:
• Position change and back massage
Changing the patient's position every two hours as follows in the same order: supine position with a head angle of 15°, semi-fowler position with a head angle of 30°, lateral right or left position with a head angle of 15°. Also, the researcher applied a simple stroke of lower back massage for 5 minutes every 2 hours
• Early ambulation
The patient ambulated after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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

Outcome

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