Determination of the Effect of Raised Supine Position and Back Support on Back Pain, Anxiety and Comfort Level in Coronary Angiography Patients
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2022
CompletedFirst Submitted
Initial submission to the registry
September 16, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2022
CompletedSeptember 22, 2022
September 1, 2022
5 months
September 16, 2022
September 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Back pain
The patient will also have less back pain.
4 hour
Anxiety
Patient anxiety will decrease
4 hour
Comfort
Patient comfort will increase
4 hour
Study Arms (2)
Experimental group
EXPERIMENTALPatients 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".
control group
NO 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 .
Interventions
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.
Eligibility Criteria
You may qualify if:
- No communication barrier that will affect cognitive functions, 18 years old and over, Femoral angiography procedure performed.
You may not qualify if:
- Bilinci kapalı olan, Psikiyatrik bir hastalığı olan, Sırt ameliyatı geçiren/bel fıtığı olan, Kronik bel veya sırt ağrısı olan, Radiyal anjiyografi işlemi yapılan.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KahramanmarasSIU
Kahramanmaraş, 46100, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 38955437DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer, Doctor
Study Record Dates
First Submitted
September 16, 2022
First Posted
September 19, 2022
Study Start
September 1, 2021
Primary Completion
January 30, 2022
Study Completion
January 30, 2022
Last Updated
September 22, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share
Individual data will be kept confidential