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The Effect of Music Concert and Inhaler Aromatherapy Applied to Patients Who Have Had Coronary Angiography on Pain Severity, Anxiety and Fear Levels

Primary Purpose

Anxiety, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
aromatherapy
music concert
aromatherapy and music concert,
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring coronary angiography, aromatherapy, music concert

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being over 18 years old Ability to communicate adequately Absence of psychiatric problems Absence of an obstacle to smell Volunteering to participate in the research No sedation before and during the procedure No known allergy to the essential oils to be applied. Volunteering to participate in the research Exclusion Criteria: Those who have communication problems Those with psychiatric problems Having a history of allergies Having a known allergy to the essential oils to be applied Having a condition that prevents smelling Being uncomfortable with the smell to be applied

Sites / Locations

  • Gülcan B Turan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

aromatherapy

music concert

aromatherapy,music concert

control

Arm Description

aromatherapy will be applied

music concert will be applied

aromatherapy, music concert will be applied

Routine maintenance will be applied.

Outcomes

Primary Outcome Measures

Visual Analog Scale-Pain
Visual Analog Scale is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.0 points means no pain, 100 points means a lot of pain
Visual Analog Scale - fear
Patients are asked to show the intensity of fear on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable fear, 0 means no fear. The VAS scale is frequently used in the evaluation of fear severity. While the patient marks the fear he/she has felt on this line, each point he/she has marked is measured in cm.
Visual Analog Scale - Anxiety
Patients are asked to show the intensity of anxiety on a 10 cm long horizontal line during activity or rest. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. VAS is frequently used in the evaluation of pain intensity. While the patient marks the anxiety he has felt on this line, each point he has marked is measured in cm.
State-Trait Anxiety Scale
In this study, the part of the scale measuring trait anxiety was used to determine the trait anxiety levels of the patients. Trait Anxiety Inventory is a 4-point Likert-type with 20 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the degree of severity of the feelings, thoughts or behaviors expressed by the items. . There are direct or reverse scored statements in the scale. Reverse scored statements; Items 1, 6, 7, 10, 13, 16 and 19. Trait anxiety score is obtained by adding the constant value of 35, which is the constant value of the trait anxiety scale, to the value obtained by subtracting the total score of the reverse scored statements from the total score of the direct statements. The lowest score that can be obtained from the scale is 20, and the highest score is 80. A high score indicates a high level of anxiety, a low score indicates a low level of anxiety.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2022
Last Updated
June 6, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05622383
Brief Title
The Effect of Music Concert and Inhaler Aromatherapy Applied to Patients Who Have Had Coronary Angiography on Pain Severity, Anxiety and Fear Levels
Official Title
Music Concert and Inhaler Aromatherapy Applied to Patients Who Have Had Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
February 25, 2023 (Actual)
Study Completion Date
June 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

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

5. Study Description

Brief Summary
Coronary angiography; It is defined as the imaging of the coronary arteries by providing the catheterization of the femoral, brachial or radial arteries, and the administration of contrast material under the guidance of fluoroscopy. Coronary angiography is a stressful procedure for the patient. Because patients are conscious during the procedure, they may experience anxiety about possible complications and an uncertain outcome. Anxiety causes changes in the physiological parameters of individuals by affecting the sympathetic nervous system of individuals. As with all procedures performed in the hospital environment, patients may experience pain during coronary angiography. Coronary angiography causes fear of death and anxiety in patients due to the unknowns it contains. Aromatherapy is the use of oils obtained from plants for treatment and care. Aromatherapy provides control of pain and anxiety by affecting the amygdala and hippocampus, which regulate fear and aggression behaviors in the limbic system. Music has been used by different civilizations throughout history for purposes such as reinforcing religious feelings, intensifying emotions and curing diseases. The multifaceted effect of music on people has led to its use in treatment. Among the therapeutic benefits of listening to music are the reduction of fear, pain and anxiety by diverting the attention of the individual, affecting the autonomic nervous system and increasing the secretion of endorphins. The aim of this study is to examine the effects of aromatherapy and music listening on pain, anxiety and fear in patients who will undergo coronary angiography
Detailed Description
This study, which was planned as an experimental study with a pretest-posttest control group, will be a study for patients who will undergo coronary angiography in the angiography unit of Fırat University Hospital and Fethi Sekin City Hospital. Prior to the study, a priori power analysis was performed to determine the sample size in this study. In the power analysis, it was determined that a total of at least 120 samples, including 1st Group 30, 2nd Group 30, 3rd Group 30 and control group 30, should be at 0.05 significance level, 95% confidence interval, 95% power and 5% margin of error. Random numbers table will be used to determine the experimental and control groups. Then, by drawing lots, 1.2.3. experimental group and control group will be assigned. The patients in the experimental group will be divided into three as those who will be treated only with music, who will be treated with aromatherapy only through inhalation, and those who will be treated with music and inhalation aromatherapy together. Before any intervention is made in the intervention group and control group, the Patient Information Form, Visual Analog Scale-Pain (VAS-P), Visual Analog Scale-Fear (VAS-F), Visual Analog Scale was given to the patients to determine the pain, anxiety and fear level of these patients. -Anxiety (VAS-A), State-Trait Anxiety Inventory (DSÖ) will be used to pre-test. Inhaler aromatherapy, music concert, music concert and inhaler aromatherapy applications will be applied to the patients in the intervention groups before and during the procedure, while the control group will not receive any intervention. With the post-test, VAS-P, VAS-F, VAS-A, DSÖ will be applied to both the intervention and control groups and their pain, anxiety and fear levels will be evaluated. Finally, it will be checked whether there is a significant difference between the pre-test and post-test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain
Keywords
coronary angiography, aromatherapy, music concert

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
aromatherapy, music concert
Masking
Participant
Masking Description
aromatherapy, music concert
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aromatherapy
Arm Type
Experimental
Arm Description
aromatherapy will be applied
Arm Title
music concert
Arm Type
Experimental
Arm Description
music concert will be applied
Arm Title
aromatherapy,music concert
Arm Type
Experimental
Arm Description
aromatherapy, music concert will be applied
Arm Title
control
Arm Type
No Intervention
Arm Description
Routine maintenance will be applied.
Intervention Type
Other
Intervention Name(s)
aromatherapy
Intervention Description
aromatherapy,
Intervention Type
Other
Intervention Name(s)
music concert
Intervention Description
music concert
Intervention Type
Other
Intervention Name(s)
aromatherapy and music concert,
Intervention Description
aromatherapy and music concert,
Primary Outcome Measure Information:
Title
Visual Analog Scale-Pain
Description
Visual Analog Scale is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.0 points means no pain, 100 points means a lot of pain
Time Frame
1 hours later
Title
Visual Analog Scale - fear
Description
Patients are asked to show the intensity of fear on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable fear, 0 means no fear. The VAS scale is frequently used in the evaluation of fear severity. While the patient marks the fear he/she has felt on this line, each point he/she has marked is measured in cm.
Time Frame
1 hours later
Title
Visual Analog Scale - Anxiety
Description
Patients are asked to show the intensity of anxiety on a 10 cm long horizontal line during activity or rest. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. VAS is frequently used in the evaluation of pain intensity. While the patient marks the anxiety he has felt on this line, each point he has marked is measured in cm.
Time Frame
1 hours later
Title
State-Trait Anxiety Scale
Description
In this study, the part of the scale measuring trait anxiety was used to determine the trait anxiety levels of the patients. Trait Anxiety Inventory is a 4-point Likert-type with 20 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the degree of severity of the feelings, thoughts or behaviors expressed by the items. . There are direct or reverse scored statements in the scale. Reverse scored statements; Items 1, 6, 7, 10, 13, 16 and 19. Trait anxiety score is obtained by adding the constant value of 35, which is the constant value of the trait anxiety scale, to the value obtained by subtracting the total score of the reverse scored statements from the total score of the direct statements. The lowest score that can be obtained from the scale is 20, and the highest score is 80. A high score indicates a high level of anxiety, a low score indicates a low level of anxiety.
Time Frame
1 hours later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being over 18 years old Ability to communicate adequately Absence of psychiatric problems Absence of an obstacle to smell Volunteering to participate in the research No sedation before and during the procedure No known allergy to the essential oils to be applied. Volunteering to participate in the research Exclusion Criteria: Those who have communication problems Those with psychiatric problems Having a history of allergies Having a known allergy to the essential oils to be applied Having a condition that prevents smelling Being uncomfortable with the smell to be applied
Facility Information:
Facility Name
Gülcan B Turan
City
Elazığ
State/Province
Merkez
ZIP/Postal Code
23100
Country
Turkey

12. IPD Sharing Statement

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The Effect of Music Concert and Inhaler Aromatherapy Applied to Patients Who Have Had Coronary Angiography on Pain Severity, Anxiety and Fear Levels

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