search
Back to results

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

Primary Purpose

Coronary Angiography Patient, Anxiety, Back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Determination of the Effect of Raised Supine Position and Back Support on Back Pain, Anxiety and Comfort Level in Coronary Angiography Patients
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Angiography Patient focused on measuring Patient Position, Pillow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • KahramanmarasSIU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

control group

Arm Description

Patients 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".

After 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 .

Outcomes

Primary Outcome Measures

Back pain
The patient will also have less back pain.
Anxiety
Patient anxiety will decrease
Comfort
Patient comfort will increase

Secondary Outcome Measures

Full Information

First Posted
September 16, 2022
Last Updated
September 20, 2022
Sponsor
Kahramanmaras Sutcu Imam University
search

1. Study Identification

Unique Protocol Identification Number
NCT05546216
Brief Title
Determination of the Effect of Raised Supine Position and Back Support on Back Pain, Anxiety and Comfort Level in Coronary Angiography Patients
Official Title
Determination of the Effect of Raised Supine Position and Back Support on Back Pain, Anxiety and Comfort Level in Coronary Angiography Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Angiography Patient, Anxiety, Back Pain, Comfort
Keywords
Patient Position, Pillow

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients 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".
Arm Title
control group
Arm Type
No Intervention
Arm Description
After 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 .
Intervention Type
Other
Intervention Name(s)
Determination of the Effect of Raised Supine Position and Back Support on Back Pain, Anxiety and Comfort Level in Coronary Angiography Patients
Intervention Description
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.
Primary Outcome Measure Information:
Title
Back pain
Description
The patient will also have less back pain.
Time Frame
4 hour
Title
Anxiety
Description
Patient anxiety will decrease
Time Frame
4 hour
Title
Comfort
Description
Patient comfort will increase
Time Frame
4 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No communication barrier that will affect cognitive functions, 18 years old and over, Femoral angiography procedure performed. Exclusion Criteria: Bilinci kapalı olan, Psikiyatrik bir hastalığı olan, Sırt ameliyatı geçiren/bel fıtığı olan, Kronik bel veya sırt ağrısı olan, Radiyal anjiyografi işlemi yapılan.
Facility Information:
Facility Name
KahramanmarasSIU
City
Kahramanmaras
ZIP/Postal Code
46100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual data will be kept confidential
Available IPD and Supporting Information:
Available IPD/Information Type
REFERENCE
Available IPD/Information URL
https://doi.org/10.1016/j.ctcp.2019.101068
Available IPD/Information Type
REFERENCE
Available IPD/Information URL
http://dx.doi.org/10.1016/j.ijcard.2016.11.043
Available IPD/Information Type
REFERENCE
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4540812/
Available IPD/Information Type
REFERENCE
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/30367542/
Available IPD/Information Type
REFERENCE
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/18065335/
Available IPD/Information Type
REFERENCE
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/35307131/
Available IPD/Information Type
REFERENCE
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/17056770/
Available IPD/Information Type
REFERENCE
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/27252099/
Available IPD/Information Type
REFERENCE
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/33632127/
Available IPD/Information Type
REFERENCE
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/26171374/
Available IPD/Information Type
REFERENCE
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/29476940/

Learn more about this trial

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

We'll reach out to this number within 24 hrs