NCT05546216

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

September 16, 2022

Last Update Submit

September 20, 2022

Conditions

Keywords

Patient PositionPillow

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

EXPERIMENTAL

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".

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

control group

NO INTERVENTION

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 .

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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

MeSH Terms

Conditions

Anxiety DisordersBack Pain

Condition Hierarchy (Ancestors)

Mental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Available IPD Datasets

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Locations