Clinical trial NCT06643182: Use of Back Support After Transfemoral Angiography
Official title: Effect of Back Support on Vital Signs and Comfort After Transfemoral Angiography
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patient Engagement
Femoral Angiography
Keywords: femoral angiography
back support
vital signs
comfort
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients over the age of 18 who underwent femoral coronary angiography,
* Patients who did not have verbal communication problems,
* Patients who consented to participate in the study were determined as patients.

Exclusion Criteria:

* Patients who underwent radial angiography,
* Have chronic low back pain,
* Have had previous back surgery/herniated disc,
* Have coagulation problems (PLT\<50000 mm3),
* Did not consent to participate in the study,
* Have communication problems.

Primary outcomes:
measure: Effect of back support use on pulse
timeFrame: 6 hour (Data collection time for each patient)
measure: Effect of back support use on blood pressure
timeFrame: 6 hour (Data collection time for each patient)
measure: Effect of back support use on respiratory rate
timeFrame: 6 hour (Data collection time for each patient)
measure: Effect of back support use on partial oxygen saturation
timeFrame: 6 hour (Data collection time for each patient)
measure: Effect of back support use on comfort
timeFrame: 6 hour
Secondary outcomes:
measure: Effect of back support use on pain
timeFrame: 6 hour
Other outcomes:
Locations:
city: Tunceli
country: Turkey
facility: Tunceli State Hospital
Study officials:
References: