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

July 1, 2022 updated by: Suad Elsaman, Alexandria University

Effect of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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".

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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
The patient ambulated after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After six hours post transfemoral coronary angiography
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.
After six hours post transfemoral coronary angiography
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).
After six hours post transfemoral coronary angiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Chair: Alexandria University, Faculty of Nursing, Alexandria university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (ACTUAL)

July 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 1, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Transfemoral Complication

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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