Tunceli State Hospital
Tunceli, Turkey (Türkiye)
Location contact
Mehdi Onaç, specialist doctor
CONTACT
NCT Number: NCT06643182
In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Increased pressure disrupts cell and tissue blood supply. The resulting pain may increase sympathetic stimulation. Therefore, sympathetic stimulation increases heart rate, blood pressure, myocardial oxygen consumption and cardiac workload. After the transfemoral coronary angiography (CAG) procedure, which is frequently applied to adults for both diagnosis and treatment, the back support to be applied to ensure that the vital signs (pulse, blood pressure, respiratory rate and blood oxygen saturation) of the patients remain stable and to increase their comfort level can prevent the deviation of the vital signs of the patients from normal and contribute to the treatment process with patient satisfaction.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Interventional
Not applicable
Tunceli, Turkey (Türkiye)
Mehdi Onaç, specialist doctor
CONTACT
In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Increased pressure disrupts cell and tissue blood supply. The resulting pain may increase sympathetic stimulation. Therefore, sympathetic stimulation increases heart rate, blood pressure, myocardial oxygen consumption and cardiac workload. After the transfemoral coronary angiography (CAG) procedure, which is frequently applied to adults for both diagnosis and treatment, the back support to be applied to ensure that the vital signs (pulse, blood pressure, respiratory rate and blood oxygen saturation) of the patients remain stable and to increase their comfort level can prevent the deviation of the vital signs of the patients from normal and contribute to the treatment process with patient satisfaction.
This study will be conducted to evaluate the effect of back support on patients undergoing transfemoral angiography on the patients' vital signs, which are defined as pulse, blood pressure, respiratory rate and blood oxygen saturation (SPO2), as well as comfort levels indicating satisfaction levels.
The study is planned to be completed between September 1, 2024 and April 1, 2025. The universe of the study, which was conducted as a randomized controlled trial model, consisted of patients who underwent angiography in the cardiovascular surgery intensive care units of Tunceli State Hospital. Randomization of the participants was planned to be assigned to the experimental and control groups via random.org (Back support group=40, Control group=40). "Patient Information Form", "Visual Analog Scale (VAS)" and "Immobilization Comfort Scale (IMC)" will be used in data collection. General linear model and mixed ANOVA analysis will be performed according to the characteristics of the data.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
When the sandbag is to be left by the researcher together with the nurse caring for the patient, the patient will be placed in the left lateral position for a short time, a gel-filled orthopedic non-sweating viscose pillow will be placed in the patient's lumbar region and the patient will be placed in a supine position with the head supported.
Time frame: 6 hour (Data collection time for each patient)
Patients will be monitored for 6 hours in a supported supine position and Pulse will be recorded at 3-hour intervals.
Time frame: 6 hour (Data collection time for each patient)
Patients will be monitored for 6 hours in a supported supine position and blood pressure will be recorded at 3-hour intervals.m
Time frame: 6 hour (Data collection time for each patient)
Patients will be monitored for 6 hours in a supported supine position and respiratory rate will be recorded at 3-hour intervals.m
Time frame: 6 hour (Data collection time for each patient)
Patients will be monitored for 6 hours in a supported supine position and partial oxygen saturation will be recorded at 3-hour intervals.m
Time frame: 6 hour
The immobilization comfort scale consists of 20 items and 6 statements. The total score is between 20 and 120. Scoring was done before and after back support.
Time frame: 6 hour
The numbers on the pain scale (VAS) are ranked from 0 to 10 at equal intervals, with pain intensity of 1-3 indicating mild pain; 4-6 indicating moderate pain; and 7-10 indicating severe pain. Scoring was done at 0th hour (before back support), 3rd hour (during back support) and 6th hour (after back support).
Contact information is provided by the study sponsor or research team.
Dilek Olmaz, PhD
CONTACT
Mensure Turan, PhD
CONTACT
Inonu University
Other
Effect of Back Support on Vital Signs and Comfort After Transfemoral Angiography
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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