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

NCT ID: NCT05622383

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2023-06-06

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.

Conditions

Anxiety; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

aromatherapy

aromatherapy will be applied

Group Type: EXPERIMENTAL

aromatherapy

Intervention Type: OTHER

aromatherapy,

music concert

music concert will be applied

Group Type: EXPERIMENTAL

music concert

Intervention Type: OTHER

music concert

aromatherapy,music concert

aromatherapy, music concert will be applied

Group Type: EXPERIMENTAL

aromatherapy and music concert,

Intervention Type: OTHER

aromatherapy and music concert,

control

Routine maintenance will be applied.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

aromatherapy

aromatherapy,

Intervention Type: OTHER

music concert

music concert

Intervention Type: OTHER

aromatherapy and music concert,

aromatherapy and music concert,

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

gülcan bahcecioğlu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gülcan B Turan

Elâzığ, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022/ 10- 35

Identifier Type: -

Identifier Source: org_study_id