The Effect of Position on Pain, Bleeding, Hematoma and Vital Signs After Transfemoral Coronary Angiography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Mersin University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale
Study Overview
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.
Detailed Description
Since coronary angiography is an invasive procedure, the prevention of complications is critical for nursing care. As a result of this procedure, complications such as bleeding, local vascular problems such as hematoma, ecchymosis, pseudoaneurysm, pain and vasovagal reactions triggered by pain may occur. However, it is possible to minimize these complications with appropriate nursing approaches and care. By carefully monitoring patients before and after the procedure, nurses play an important role in reducing the risk of complications and ensuring patient safety.
The mobility of patients both in bed and in the room after coronary angiography may increase the rate of complications such as bleeding, pain and hematoma. For this reason, complete bed rest is traditionally recommended in addition to manual pressure application to stop bleeding after intervention in the femoral artery procedure. However, this approach may cause problems in terms of patient comfort and increases the workload of healthcare personnel. Sandbags are used to make prints in some clinics. However, while these bags cause pain and discomfort to patients due to lying still for a long time, they can also cause bleeding and hematoma due to slipping of the sandbag, and can be especially challenging for elderly patients. In this case, the methods that can be applied should be applied in a short time and easily. Positioning increases blood circulation and prevents contraction and spasm of the muscles. It is also easy and quick to apply. As a result of this method, the level of pain decreases. Positioning is effective in acute pain. It is not recommended to give a position without evaluating the general condition of the patient. An assessment of the overall situation is necessary to understand all of the patient's health needs and provide comprehensive care. This assessment helps to determine the patient's general health status, current symptoms, and needs. Positioning is also part of this assessment. The decrease in pain depending on the position reduces the patient's desire to move. This makes it easier to evaluate the patient in terms of the amount of bleeding and the risk of hematoma formation. In the literature, there are studies evaluating pain or hematoma after transfemoral coronary angiography by applying different methods. There is a study evaluating the effect of supine position on pain and hematoma. However, there are no studies evaluating the effect of four parameters including pain, bleeding, hematoma and vital signs. In order to eliminate this deficiency in the literature, it was aimed to evaluate the effect of supine position, which varies depending on the angles after transfemoral coronary angiography, on pain, bleeding amount, hematoma and vital signs in the patient. Four different hypothesis sets were established in the research. These; First Hypothesis Team H0: The position applied to transfemoral coronary angiography patients has no effect on pain.
H1: The position applied to transfemoral coronary angiography patients has an effect on pain.
Second Hypothesis Team H0: The position applied to transfemoral coronary angiography patients has no effect on bleeding.
H1: The position applied to transfemoral coronary angiography patients has an effect on bleeding.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Hours to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Exclusion criteria;
- •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
Arms & Interventions
ENTERPRISE GROUP
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.
Intervention: Bed Position and Head Elevation (Other)
CONTROL GROUP
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.
Outcomes
Primary Outcomes
Visual Analog Scale
Time Frame: Pre-intervention and after the intervention 6 hour.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mizgin Bakır
Principal Investigator
Mersin University