Comfort Level After Transfemoral Coronary Angiography
Primary Purpose
Coronary Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobility group
Sponsored by
About this trial
This is an interventional supportive care trial for Coronary Disease focused on measuring comfort, coronary angiography, vital signs
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
Outcomes
Primary Outcome Measures
Pulse rate per minute
Vital signs
blood pressure rate, mmHg
Vital signs
respiratory rate per minute
Vital signs
SpO2 value of the patients will be measured.
Vital signs
Secondary Outcome Measures
General Comfort Scale
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).
Full Information
NCT ID
NCT06088095
First Posted
October 5, 2023
Last Updated
October 17, 2023
Sponsor
TC Erciyes University
1. Study Identification
Unique Protocol Identification Number
NCT06088095
Brief Title
Comfort Level After Transfemoral Coronary Angiography
Official Title
The Effect of Gradual Mobilization on Vital Signs and Comfort Level After Transfemoral Coronary Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
comfort, coronary angiography, vital signs
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Mobility group
Intervention Description
Patients will be mobilized in accordance with the gradual mobilization procedure 12 hours after the angiography procedure.
Primary Outcome Measure Information:
Title
Pulse rate per minute
Description
Vital signs
Time Frame
20 minutes
Title
blood pressure rate, mmHg
Description
Vital signs
Time Frame
20 minutes
Title
respiratory rate per minute
Description
Vital signs
Time Frame
20 minutes
Title
SpO2 value of the patients will be measured.
Description
Vital signs
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
General Comfort Scale
Description
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).
Time Frame
The comfort scale will be filled 2 hours after mobilization.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ÖZLEM CEYHAN
Phone
+90352 207 6666
Ext
28561
Email
ozlemg@erciyes.edu.tr
12. IPD Sharing Statement
Citations:
PubMed Identifier
36414367
Citation
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.
Results Reference
background
PubMed Identifier
27931870
Citation
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.
Results Reference
background
PubMed Identifier
32020631
Citation
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.
Results Reference
background
PubMed Identifier
19296949
Citation
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.
Results Reference
background
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Comfort Level After Transfemoral Coronary Angiography
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