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NCT Number: NCT06643182

Use of Back Support After Transfemoral Angiography

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tunceli State Hospital

Tunceli, Turkey (Türkiye)

Location contact

Mehdi Onaç, specialist doctor

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Back Support

Other

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 outcomes

  1. Effect of back support use on pulse

    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.

  2. Effect of back support use on blood pressure

    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

  3. Effect of back support use on respiratory rate

    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

  4. Effect of back support use on partial oxygen saturation

    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

  5. Effect of back support use on comfort

    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.

Secondary outcomes

  1. Effect of back support use on pain

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Dilek Olmaz, PhD

CONTACT

[email protected]

+90 5349598752

Mensure Turan, PhD

CONTACT

[email protected]

+90 536 412 51 21

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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