AnxietyNCT05622383
The Effect of Music Concert and Inhaler Aromatherapy Applied to Patients Who Have Had Coronary Angiography on Pain Severity, Anxiety and Fear Levels
A study testing aromatherapy, music concert and aromatherapy and music concert, in people with Anxiety and Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- What is being tested?
- aromatherapy, music concert and aromatherapy and music concert,
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2022to 6 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Concert and Inhaler Aromatherapy Applied to Patients Who Have Had Coronary Angiography
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
Read the 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.
- Being tested
- aromatherapy, music concert, aromatherapy and music concert,
- Keywords
- coronary angiography, aromatherapy, music concert
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromatherapyOther
aromatherapy,
music concertOther
music concert
aromatherapy and music concert,Other
aromatherapy and music concert,
| Study group | Role | What they receive |
|---|---|---|
| aromatherapy | Experimental | aromatherapy will be applied Receives: Other: aromatherapy |
| music concert | Experimental | music concert will be applied Receives: Other: music concert |
| aromatherapy,music concert | Experimental | aromatherapy, music concert will be applied Receives: Other: aromatherapy and music concert, |
| control | No intervention | Routine maintenance will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start11 Nov 2022
- Primary completion25 Feb 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- aromatherapy, music concert
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gülcan bahcecioğlu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622383
- Sponsor's protocol ID
- 2022/ 10- 35
- Status last verified
- Jun 2023
- First submitted
- 11 Nov 2022
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gur F, Turan GB. Effects of Music Therapy and Inhalation Aromatherapy on Pain Intensity, Anxiety, and Fear Levels in Patients Undergoing Coronary Angiography: A Randomized Controlled Trial. Pain Res Manag. 2026 Feb 17;2026:9447650. doi: 10.1155/prm/9447650. eCollection 2026.
PubMed 41716781
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Concert and Inhaler Aromatherapy Applied to Patients Who Have Had Coronary Angiography
- ClinicalTrials.gov ID
- NCT05622383
- Acronym / sponsor ID
- 2022/ 10- 35
- Keywords
- coronary angiography, aromatherapy, music concert
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- aromatherapy, music concert
| Arm | Type | Receives |
|---|---|---|
| aromatherapy | Experimental | Other: aromatherapyaromatherapy will be applied |
| music concert | Experimental | Other: music concertmusic concert will be applied |
| aromatherapy,music concert | Experimental | Other: aromatherapy and music concert,aromatherapy, music concert will be applied |
| control | No intervention | –Routine maintenance will be applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being over 18 years old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aromatherapyaromatherapy, | Other | aromatherapy |
| music concertmusic concert | Other | music concert |
| aromatherapy and music concert,aromatherapy and music concert, | Other | aromatherapy,music concert |
Primary outcome
Visual Analog Scale-Pain
Time frame: 1 hours later
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
Time frame: 1 hours later
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
Time frame: 1 hours later
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
Time frame: 1 hours later
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Derived from this study: PubMed 41716781Gur F, Turan GB. Effects of Music Therapy and Inhalation Aromatherapy on Pain Intensity, Anxiety, and Fear Levels in Patients Undergoing Coronary Angiography: A Randomized Controlled Trial. Pain Res Manag. 2026 Feb 17;2026:9447650. doi: 10.1155/prm/9447650. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aromatherapy, music concert and aromatherapy and music concert, in people with Anxiety and Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale-Pain (time frame: 1 hours later). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05622383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.