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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05446987
Enrollment
185
Registered
2022-07-07
Start date
2017-03-01
Completion date
2018-08-01
Last updated
2022-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

coronary angiography, Complications, Early ambulation, Position, Transfemoral, Back massage

Brief summary

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

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.

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Oozing and bleeding scaleAfter six hours post transfemoral coronary angiographyIt 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.
Ecchymosis and hematoma formation scaleAfter six hours post transfemoral coronary angiographyIt 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.
Numeric rating scaleAfter six hours post transfemoral coronary angiographyThe 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026