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CompletedNCT05446987Updated Jul 7, 2022

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

An interventional study of Position change and back massage and Early ambulation in Catheter Complications, Ambulation Difficulty and Bleeding, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-07-07.

Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 years 4 months after the study started (first participant enrolled Mar 2017, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
185
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed 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".

02

Conditions studied

  • Catheter Complications
  • Ambulation Difficulty
  • Bleeding
  • Back Pain
  • Oozing
  • Hematoma

Keywords

  • coronary angiography
  • Complications
  • Early ambulation
  • Position
  • Transfemoral
  • Back massage
03

In context

Mobility Limitation

321 studies on the registry are indexed under Mobility Limitation; 97 are open to participants now.

This study's enrollment of 185 is above the median of 46 across 269 interventional studies indexed under Mobility Limitation.

Browse Mobility Limitation studies →

Lead sponsor

Alexandria University is the lead sponsor of 586 studies on the registry; 128 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
185 participants (actual)

Study arms

  • Experimental
    Position change and back massage group

    The patients received changing of 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 patients received a simple stroke of lower back massage for 5 minutes every 2 hours

    Other: Position change and back massage

  • Experimental
    Early ambulation

    The patient are allowed to ambulate after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle.

    Other: Early ambulation

Interventions

  • OtherPosition 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

  • OtherEarly ambulation

    The patient ambulated after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: After six hours post transfemoral coronary angiography

  2. 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.

    Time frame: After six hours post transfemoral coronary angiography

  3. 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).

    Time frame: After six hours post transfemoral coronary angiography

07

Study locations

1 site
  • Alexandria University
    Alexandria, Egypt
08

References and documents

Publications

  • 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. doi: 10.1002/ccd.1810280107. PubMed 8416329 ↗
  • 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. PubMed 23076977 ↗
  • 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. doi: 10.1136/hrt.75.5.477. PubMed 8665340 ↗
  • 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. doi: 10.1002/(sici)1097-0304(199709)42:13.0.co;2-8. PubMed 9286529 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05446987
Responsible party
Suad Elsaman (Assistant professor, Alexandria University) — Principal investigator
First posted
Jul 7, 2022
Start date
Mar 1, 2017
Primary completion
Aug 1, 2018
Completion
Aug 1, 2018
Last update
Jul 7, 2022

Study contacts

Alexandria University
study chair · Faculty of Nursing, Alexandria University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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