The Effect of Position on Pain, Bleeding, Hematoma and Vital Signs After Transfemoral Coronary Angiography

NCT06795308 | Not Yet Recruiting

• 1 other identifier: MERSİNU2024-TFCA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, it was aimed to determine the effect of the special position given to the patient after transfemoral coronary angiography (supine position that varies depending on the angles) on pain, bleeding, hematoma and vital signs.

Conditions

Coronary Disease; Angiography

Keywords

position; transfemoral coronary angiography; pain; bleeding; hematoma

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  First evaluation criterion after transfemoral coronary angiography is pain. The results will be evaluated using the Visual Analog Scale. "No pain" is rated as 0 points (minimum value) and "very severe pain" is rated as 10 points (maximum value). Pain will decrease as Visual Analog Scale score decreases.

  Pre-intervention and after the intervention 6 hour.

Study Arms (2)

ENTERPRISE GROUP

ACTIVE COMPARATOR

The first group will remain in the supine position for 6 hours after the Angiography procedure, and the treated leg will be kept straight and immobile. Patients will not move their legs during this period. A sandbag weighing approximately 4 kg will be placed over the catheter dressing for 6 hours to prevent bleeding and subcutaneous blood accumulation. For the first two hours, the patient will lie on his back and on a flat surface with his legs extended straight. During the remaining 4 hours, investigators will monitor the patient's bed head by raising it 15 degrees intermittently under the supervision of the doctor, and at the end of the 6th hour, the sandbag on the leg will be removed. Blood pressure, pulse rate, respiratory rate, body temperature, as well as pain level will be measured every two hours.

Other: Bed Position and Head Elevation

CONTROL GROUP

NO INTERVENTION

After the angiography procedure, the patient will remain in the supine position for 6 hours and the treated leg will remain straight and motionless. investigators will ask patients not to move their legs during this time. A sandbag weighing approximately 4 kg will be placed over the catheter dressing for 6 hours to prevent bleeding and subcutaneous blood accumulation. Patients will lie on their back and on a flat surface with their legs extended straight for 6 hours. At the end of the 6th hour, the sandbag on the leg is removed. Blood pressure, pulse rate, respiratory rate, body temperature, as well as pain level will be measured every 2 hours.

Interventions

Bed Position and Head Elevation OTHER

The first group will remain in the supine position for 6 hours after the Angiography procedure, and the treated leg will be kept straight and immobile. Patients will not move their legs during this period. A sandbag weighing approximately 4 kg will be placed over the catheter dressing for 6 hours to prevent bleeding and subcutaneous blood accumulation. For the first two hours, the patient will lie on his back and on a flat surface with his legs extended straight. During the remaining 4 hours, investigators will monitor the patient's bed head by raising it 15 degrees intermittently under the supervision of the doctor, and at the end of the 6th hour, the sandbag on the leg will be removed. Blood pressure, pulse rate, respiratory rate, body temperature, as well as pain level will be measured every two hours.

ENTERPRISE GROUP

Eligibility Criteria

• Age: 18 Hours+
• Gender Eligibility Details: women/men
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written and verbal permission was obtained to participate in the research.
• Able to read, write, speak and understand Turkish
• Those who are over 18 years old
• Planned transfemoral angiography was performed
• Having normal prothrombin time (PT) and international normalization ratio (INR)
• Being conscious, fully oriented and cooperative, and open to communication.
• Those whose general condition is good and comfortable (vital signs are within normal limits)
• Not using any sedative medication,
• Those who have not previously had widespread hemorrhage, large hematoma, or a pain sensation greater than 4.5 on the visual pain scale
• Patients with imaging, medical treatment, stents, balloons, stents and balloons as a result of the procedure
• Not having any psychiatric disease

You may not qualify if:

• People with hemophilia or other coagulation defects
• Those with active hemorrhage
• Previously treated with streptokinase
• Using more than 2 anticoagulants or antiplatelets
• Those who have had back surgery/herniated disc,
• Having chronic waist, back or leg pain
• Using any of the complementary and integrated methods
• Do not use any analgesic before, during and after transfemoral angiography.
• Radial angiography procedure was performed
• Patients coming to the service with sandbags
• Those who had any health problems or lost their lives during the application process
• Those who cannot continue the research for any reason
• Patients who wish to leave the study with their own consent

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Adana City Training and Research Hospital

Adana, Yüreğir, 1370, Turkey (Türkiye)

Location

Related Publications (1)

• Valiee S, Fathi M, Hadizade N, Roshani D, Mahmoodi P. Evaluation of feasibility and safety of changing body position after transfemoral angiography: A randomized clinical trial. J Vasc Nurs. 2016 Sep;34(3):106-15. doi: 10.1016/j.jvn.2016.05.001.

  PMID: 27568318 RESULT

Related Links

• PubMed

MeSH Terms

Conditions

Coronary Disease; Pain; Hemorrhage; Hematoma

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Digdem LAFCI BAKAR, PhD

  Mersin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Digdem LAFCI BAKAR, PhD

CONTACT

+905055803847; didemlafcı@hotmail.com

Mizgin BAKIR, Msc Student

CONTACT

+905050156828; mizginbldz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The first group will remain in the supine position for 6 hours after the Angiography procedure, and the treated leg will be kept straight and immobile. Patients will not move their legs during this period. A sandbag weighing approximately 4 kg will be placed over the catheter dressing for 6 hours to prevent bleeding and subcutaneous blood accumulation. For the first two hours, the patient will lie on his back and on a flat surface with his legs extended straight. During the remaining 4 hours, researchers will monitor the patient's bed head by raising it 15 degrees intermittently under the supervision of the doctor, and at the end of the 6th hour, the sandbag on the leg will be removed. Blood pressure, pulse rate, respiratory rate, body temperature, as well as pain level will be measured every two hours. In the second group, only the patient's bed head will remain flat and will not be elevated.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: January 28, 2025
• Study Start: February 3, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 1 year after the publication date and without an end date
• Access Criteria: Who Can Access: Access will only be open to analyzes by independent experts, academic institutions or approved health administrations. Access pieces will be evaluated as an independent review monitoring committee will evaluate them. What Will Be Accessed: Individual data (IPD) of the participants, the data in which they are presented, usage information (samples, analysis methods, data collection tools, etc.) will be shared. How They Will Access: Access may be removed through an application process that is maintained or accepted by the administrator. Once the request is approved and the application is approved, it will be accessed via special data access platforms or secure data storage areas. Types of Analysis: Sharing of data is only for analysis after an independent review committee has evaluated it. These analyzes need to be monitored, monitored, and analysis types need to be combined and committees created.

Locations

TU (1)