Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05546216 |
| Other study ID # |
Inönü |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
January 30, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
Kahramanmaras Sutcu Imam University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
