Comfort Level After Transfemoral Coronary Angiography

February 27, 2025 updated by: Özlem Ceyhan, TC Erciyes University

The Effect of Gradual Mobilization on Vital Signs and Comfort Level After Transfemoral Coronary Angiography

With the increase in the number of cardiovascular diseases, the safety of the angiography method used in diagnosis and treatment becomes important. The transfemoral approach is often preferred during angiography. It is recommended to have bed rest for 6-12 hours after transfemoral angiography (TFA) to prevent possible complications. In order to reduce the complications arising from angiography, it is predicted from the studies that giving the patient a therapeutic position, elevating the head of the bed and gradual early mobilization will reduce the patients' groin pain, prevent urinary retention and increase patient comfort. In this study, the effect of gradual mobilization after transfemoral angiography on the vital signs, complications and comfort level of the patients. It is planned to be done to determine the

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

      • Kayseri, Turkey, 38039
        • Erciyes University Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals who can be contacted at a level that can answer research questions
  • Individuals with transfemoral angiography

Exclusion Criteria:

  • Those with hypertension
  • Individuals with psychological and neurological disorders
  • Patients with communication problems
  • Patients with deterioration in hemodynamics after angiography

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: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Experimental: intervention group
Patients will be mobilized in accordance with the gradual mobilization procedure 12 hours after the angiography procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse rate per minute
Time Frame: 20 minutes
Vital signs
20 minutes
blood pressure rate, mmHg
Time Frame: 20 minutes
Vital signs
20 minutes
respiratory rate per minute
Time Frame: 20 minutes
Vital signs
20 minutes
SpO2 value of the patients will be measured.
Time Frame: 20 minutes
Vital signs
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Comfort Scale
Time Frame: The comfort scale will be filled 2 hours after mobilization.
It is used to determine the comfort level of patients. The highest score that can be given to the positive items in the scale, four (4), indicates high comfort, and the lowest score, one (1), indicates low comfort. Thus, the lowest score that can be obtained in the GAS is 48 points, while the highest score is 192 points. As the score obtained from the scale increases, the comfort level perceived by the patient increases. The total score obtained is divided by 48, which is the number of scale items, and the average value is found in the range of 1-4. If the patient performing the scale has low comfort, it is expressed as one (1), and if the patient has high comfort, it is expressed as four (4).
The comfort scale will be filled 2 hours after mobilization.

Collaborators and Investigators

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

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.

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 15, 2024

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • coronary angiography

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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Coronary Disease

Clinical Trials on Mobility group

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