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Use of Back Support After Transfemoral Angiography

Effect of Back Support on Vital Signs and Comfort After Transfemoral Angiography

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06643182
Enrollment
80
Registered
2024-10-16
Start date
2024-11-01
Completion date
2025-09-01
Last updated
2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Angiography, Patient Engagement

Keywords

femoral angiography, back support, vital signs, comfort

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.

Interventions

OTHERBack Support

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.

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Effect of back support use on pulse6 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.
Effect of back support use on blood pressure6 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
Effect of back support use on respiratory rate6 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
Effect of back support use on partial oxygen saturation6 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
Effect of back support use on comfort6 hourThe 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.

Secondary

MeasureTime frameDescription
Effect of back support use on pain6 hourThe 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).

Countries

Turkey (Türkiye)

Contacts

Primary ContactDilek Olmaz, PhD
dilekolmaz62@hotmail.com+90 5349598752
Backup ContactMensure Turan, PhD
mensurekyn@gmail.com+90 536 412 51 21

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026