- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06088095
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
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.
Sponsor
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
- Elsaman SEA. Association of position change and back massage and early ambulation with post-transfemoral coronary angiography complications. J Vasc Nurs. 2022 Sep;40(3):128-133. doi: 10.1016/j.jvn.2022.08.003. Epub 2022 Sep 11.
- Ramos Dos Santos PM, Aquaroni Ricci N, Aparecida Bordignon Suster E, de Moraes Paisani D, Dias Chiavegato L. Effects of early mobilisation in patients after cardiac surgery: a systematic review. Physiotherapy. 2017 Mar;103(1):1-12. doi: 10.1016/j.physio.2016.08.003. Epub 2016 Sep 14.
- Ibdah RK, Ta'an WF, Shatnawi RM, Suliman MM, Rababah JA, Rawashdeh SI. The effectiveness of early position change postcardiac catheterization on patient's outcomes: A randomized controlled trial. Nurs Forum. 2020 Jul;55(3):380-388. doi: 10.1111/nuf.12438. Epub 2020 Feb 5.
- Rezaei-Adaryani M, Ahmadi F, Asghari-Jafarabadi M. The effect of changing position and early ambulation after cardiac catheterization on patients' outcomes: a single-blind randomized controlled trial. Int J Nurs Stud. 2009 Aug;46(8):1047-53. doi: 10.1016/j.ijnurstu.2009.02.004. Epub 2009 Mar 17.
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
Keywords
Additional Relevant MeSH Terms
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.
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