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Not yet recruiting NCT06643182

Use of Back Support After Transfemoral Angiography

No phase Interventional Patient Engagement Femoral Angiography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Back Support.
Who it may be relevant to
Registry conditions: Patient Engagement, Femoral Angiography. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Back 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.

Primary outcome measures

  • Effect of back support use on pulse [Time frame: 6 hour (Data collection time for each patient)]
  • Effect of back support use on blood pressure [Time frame: 6 hour (Data collection time for each patient)]
  • Effect of back support use on respiratory rate [Time frame: 6 hour (Data collection time for each patient)]
  • Effect of back support use on partial oxygen saturation [Time frame: 6 hour (Data collection time for each patient)]
  • Effect of back support use on comfort [Time frame: 6 hour]
Secondary outcome measures (1)
  • Effect of back support use on pain [Time frame: 6 hour]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Tunceli State Hospital — Tunceli

Identifiers

NCT: NCT06643182 · 2024/5744

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗