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Coronary Angiography PatientNCT05546216

Determination of the Effect of Raised Supine Position and Back Support on Back Pain, Anxiety and Comfort Level in Coronary Angiography Patients

A study testing Determination of the Effect of Raised Supine Position and Back Support on Back Pain, Anxiety and Comfort Level in Coronary Angiography Patients in people with Coronary Angiography Patient and Anxiety, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In addition to pharmacological methods, non-pharmacological methods are also used to control back pain and anxiety. The aim of the study is to determine the effect of 30 degrees raised supine position and back support applied to patients undergoing coronary angiography from the femoral artery on back pain, anxiety and… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Coronary Angiography Patient, Anxiety, Back Pain
What is being tested?
Determination of the Effect of Raised Supine Position and Back Support on Back Pain, Anxiety and Comfort Level in Coronary Angiography Patients
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2021to 30 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • No communication barrier that will affect cognitive functions, 18 years old and over, Femoral angiography procedure performed.

Who cannot join

  • Bilinci kapalı olan, Psikiyatrik bir hastalığı olan, Sırt ameliyatı geçiren/bel fıtığı olan, Kronik bel veya sırt ağrısı olan, Radiyal anjiyografi işlemi yapılan.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • KahramanmarasSIU

    Kahramanmaraş, 46100

Other trials in Turkey (Türkiye)

About this study

In addition to pharmacological methods, non-pharmacological methods are also used to control back pain and anxiety. The aim of the study is to determine the effect of 30 degrees raised supine position and back support applied to patients undergoing coronary angiography from the femoral artery on back pain, anxiety and patient comfort. This research was planned as a pretest-posttest randomized, controlled, experimental study in order to determine the effect of the elevated supine position and back support application applied to patients undergoing coronary angiography with femoral artery access on back pain, anxiety and comfort levels of patients.

Research Kahramanmaraş Sütçü İmam University SUAH Hospital Cardiology intensive care unit September 2021 - September The sample of the research was determined by power analysis. According to the calculation made, the sample; With an effect size of 0.90, a margin of error of 0.05, a confidence interval of 0.95, and a power of 0.95, it was calculated that there should be 35 people in each group to represent the universe. "Patient Information Form", "Numeric Pain Intensity Scale VAS", "State- The necessary information of the patient will be collected with the "Trait Anxiety Scale" and the "Immobilization comfort scale". After the information of the patient whose hemodynamics is provided, the experimental group will be given a 30 degrees Elevated Supine Position and the back area will be supported with a 36x33x10 sized silicone gel pad that prevents sweating, and the measurements will be repeated at the 2nd and 4th hours after the CAG procedure.

The patients in the control group will have the same measurements at the 0th hour, 2nd hour and 4th hour after the femoral angiography procedure. During this period, the patients will remain in the straight supine position without back support, which is routinely applied in the clinic.

Read the detailed description

Coronary Artery Disease (CAD) is the most common system disease among cardiovascular system diseases (CVS). CVS diseases are in the first place among the top 10 causes of death stated by the World Health Organization (WHO). Every year, 17.9 million people in the world die due to CVS diseases. A similar picture is seen in our country with the world average, and according to the 2013 data of the Turkish statistical institution, 37.9% of all deaths are due to CAD. In the heart disease risk factor study of Turkish adults in 2017, the death rate of CAD in European countries between the ages of 45-74 is between 2 and 8 per thousand in men and between 0.6 and 3 per thousand in women. This rate has been reported as 7.6 in men and 3.8 in women between the ages of 45-74 in our country. Coronary angiography (CAG) procedure is currently the gold standard in the diagnosis and treatment of CAD. Complications such as bleeding, hematoma and arterial embolism may develop after CAG. Complete bed rest is recommended for approximately 6 hours after CAG to minimize these risks. During bed rest, the patient lies motionless in the supine position. Studies in the literature have also reported that lying still after CAG causes back pain. Back pain after CAG may increase sympathetic stimulation. Therefore, heart rate, blood pressure, myocardial oxygen consumption and cardiac workload increase. This may exacerbate myocardial ischemia. It is also reported in the literature that CAG is a cause of anxiety for patients. In patients hospitalized in the coronary intensive care unit after the procedure, the presence of anxiety reduces the quality of life and increases the frequency of acute coronary events, and may lead to increased mortality. In addition to pharmacological methods, non-pharmacological methods are also used to control back pain and anxiety. The aim of the study is to determine the effect of 15 degrees raised supine position and back support applied to patients undergoing coronary angiography from the femoral artery on back pain, anxiety and patient comfort. This research was planned as a pretest-posttest randomized, controlled, experimental study in order to determine the effect of the elevated supine position and back support application applied to patients undergoing coronary angiography with femoral artery access on back pain, anxiety and comfort levels of patients.

The research will be carried out in Kahramanmaraş Sütçü İmam University SUAH Hospital Cardiology intensive care unit between September 2021 and September 2022.

There is an annual average of 436 patients hospitalized for CAG in the Coronary intensive care unit in the relevant hospital. The sample of the study was determined by power analysis. According to the calculation made, the sample; With an effect size of 0.90, a margin of error of 0.05, a confidence interval of 0.95, and a power of 0.95, it was calculated that there should be 35 people in each group to represent the universe. However, considering the losses that may be experienced during the study, it was decided that it would be appropriate to take 10 extra people and each group was planned as 45 people (45+45 Experimental-Control Group). It was aimed to reach 90 patients in total. Volunteers aged 18 and over, who do not have communication barriers that may affect cognitive functions, and patients who underwent femoral angiography will be randomly assigned to the study. Data will be collected using face-to-face interview method.

The data of the study were collected from the "Patient Information Form", "Numeric Pain Intensity Scale", "State Anxiety Scale", "Immobilization comfort scale", "Back support and 15 degrees Elevated Supine Position practice plan.

The patients in the experimental group will be monitored after they are put to bed after the angiography procedure, their vital signs will be evaluated at the 0th hour, "Patient Information Form", "Numeric Pain Intensity Scale VAS (Numeric Pain Intensity Scale)", "State-Trait Anxiety Scale" and "Immobilization Comfort Scale". The necessary information of the patient will be collected with the "scale". After the information of the patient whose hemodynamics is provided, the experimental group will be given a 15 degree Elevated Supine Position and the back area will be supported with a 36x33x10 sized silicone gel pad that prevents sweating, and the measurements will be repeated at the 2nd and 4th hours after the CAG procedure.

The patients in the control group will have the same measurements at the 0th hour, 2nd hour and 4th hour after the femoral angiography procedure. During this period, the patients will remain in the straight supine position without back support, which is routinely applied in the clinic.

Being tested
Determination of the Effect of Raised Supine Position and Back Support on Back Pain, Anxiety and Comfort Level in Coronary Angiography Patients
Keywords
Patient Position, Pillow
Medical subject headings
Anxiety Disorders, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Determination of the Effect of Raised Supine Position and Back Support on Back Pain, Anxiety and Comfort Level in Coronary Angiography PatientsOther

    The study was conducted between 01 September 2021 and 30 January 2022 as a randomized single-blind interventional study with a pre-test post-test control group. The sample of the study consisted of patients who underwent coronary angiography. Data; The patient information form was collected with the visual analog scale, state anxiety and immobilization comfort scale. Back support was provided to the intervention group with a pillow at the exit of the angiography and the head of the bed was raised 30 degrees. Back pain intensity at 0, 2 and 4 hours, anxiety and comfort level at 0 and 4 hours were measured. The control group was given routine nursing care.

Study groups in NCT05546216
Study groupRoleWhat they receive
Experimental groupExperimentalPatients in the intervention group CAG exit Written informed consent was obtained from the patients for the study. Pretest data of the patients were collected at 0 hour using the "Patient Information Form", "Visual Analog Scale", "State Anxiety Scale" and "Immobility Comfort Scale". After informing the patient with hemodynamics, at the 0th hour, a 36x33x10 cm gel-containing silicone pad was placed in the lumbar cavity of the patient to fill the patient's anatomical lumbar cavity, and CAG output was supported. The patient was in the supine position 30 degrees elevated when measured with the visual aid. Patients lie in the same position for 4 hours. Back pain of the patients was evaluated again with the "Visual Analog Scale" at the 2nd hour. At the 4th hour, the posttest data of the patients were collected with the "Visual Analogue Scale", the "State Anxiety Scale" and the "Immobility Comfort Scale".
Receives: Other: Determination of the Effect of Raised Supine Position and Back Support on Back Pain, Anxiety and Comfort Level in Coronary Angiography Patients
control groupNo interventionAfter the patients in the control group were placed in the supine position on the CAG exit, they were monitored, their vital signs were evaluated, and the necessary information of the patient was collected with the "Patient Information Form", "Visual Analog Scale", "State Anxiety Scale" and "Immobilization comfort scale" at the 0th hour of CAG exit. The patient was in a routine supine position without back support for 4 hours and received standard nursing care. After the . position was given, back pain was evaluated again at the 2nd hour and 4th hour using the "Visual Analogue Scale". Anxiety and comfort levels were evaluated with the "State Anxiety Scale" and "Immobilization Comfort Scale" at the 0th minute before the position and at the 4th hour after the position .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Back pain

    The patient will also have less back pain.

    Measured: 4 hour

  2. Anxiety

    Patient anxiety will decrease

    Measured: 4 hour

  3. Comfort

    Patient comfort will increase

    Measured: 4 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2022
  2. Study start1 Sep 2021
  3. Primary completion30 Jan 2022
  4. Study completion30 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05546216
Sponsor's protocol ID
İnönü
Status last verified
Sep 2022
First submitted
16 Sep 2022
Last updated
22 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual data will be kept confidential

Publications

  • Soylu A, Korkmaz M. The effect on back pain, anxiety, and comfort levels of an elevated supine position and back support applied to patients undergoing coronary angiography: A randomized controlled experimental study. Saudi Med J. 2024 Jul;45(7):700-709. doi: 10.15537/smj.2024.45.7.20240201.

    PubMed 38955437

Questions about this trial

What is this clinical trial studying?

A study testing Determination of the Effect of Raised Supine Position and Back Support on Back Pain, Anxiety and Comfort Level in Coronary Angiography Patients in people with Coronary Angiography Patient and Anxiety, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Back pain (time frame: 4 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05546216, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.

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