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

NCT05622383 | Completed DMC

• 1 other identifier: 2022/ 10- 35
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety; Pain

Keywords

coronary angiography; aromatherapy; music concert

Outcome Measures

Primary Outcomes (4)

• 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

  1 hours later

• 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.

  1 hours later

• 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.

  1 hours later

• 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.

  1 hours later

Study Arms (4)

aromatherapy

EXPERIMENTAL

aromatherapy will be applied

Other: aromatherapy

music concert

EXPERIMENTAL

music concert will be applied

Other: music concert

aromatherapy,music concert

EXPERIMENTAL

aromatherapy, music concert will be applied

Other: aromatherapy and music concert,

control

NO INTERVENTION

Routine maintenance will be applied.

Interventions

aromatherapy OTHER

aromatherapy,

aromatherapy

music concert OTHER

music concert

music concert

aromatherapy and music concert, OTHER

aromatherapy and music concert,

aromatherapy,music concert

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Gülcan B Turan

Elâzığ, Merkez, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: aromatherapy, music concert
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: aromatherapy, music concert

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 18, 2022
• Study Start: November 11, 2022
• Primary Completion: February 25, 2023
• Study Completion: June 6, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

TU (1)