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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
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Disease focused on measuring comfort, coronary angiography, vital signs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 5, 2023
    Last Updated
    October 17, 2023
    Sponsor
    TC Erciyes University
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    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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