Skip to main content
OpenTrials
Completed

NCT Number: NCT05446987

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Catheter Complications Ambulation Difficulty Back Pain Bleeding Hematoma Hemorrhage Mobility Limitation Neurologic Manifestations Oozing Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University

Alexandria, Egypt

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Position change and back massage

Other

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

Other

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

Primary outcomes

  1. Oozing and bleeding scale

    Time frame: After six hours post transfemoral coronary angiography

    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.

  2. Ecchymosis and hematoma formation scale

    Time frame: After six hours post transfemoral coronary angiography

    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.

  3. Numeric rating scale

    Time frame: After six hours post transfemoral coronary angiography

    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).

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2022
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.