- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514299
Investigation of the Effects of Pre-Angiography Music Interview and Aromatherapy Application on Pain, Anxiety, Fear, and Comfort Levels in Cardiology Patients
This study was conducted to examine the effects of non-pharmacological interventions applied before coronary angiography in cardiology patients. Specifically, the study focused on the use of music listening and lavender oil inhalation and their potential impact on patients' psychological and physical states prior to the procedure. The research was designed as a randomized controlled experimental study, in which participants were assigned to intervention and control groups for comparison.
Within the scope of the study, pain, anxiety, fear, and comfort levels were evaluated using standardized measurement tools, and data were collected through pre- and post-intervention assessments. The study emphasizes the importance of integrating complementary methods into clinical practice within a holistic nursing care approach.
Overall, the study aims to provide scientific evidence regarding the applicability of music therapy and aromatherapy as supportive, non-pharmacological interventions in the pre-angiography care of cardiology patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34295
- Istanbul Aydin University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- No sedation before or during angiography
- No diagnosed psychiatric disorder
- Normal sense of smell
- No allergy to essential oils used
- Voluntary participation
- Scheduled for angiography within 24 hours
- Independent in activities of daily living
- Literate (able to read and write)
- No hearing impairment
- Able to communicate effectively
- No respiratory disease (e.g., asthma, COPD)
- Not using non-pharmacological methods (e.g., yoga, reiki
Exclusion Criteria:
- Communication problems
- Psychiatric disorder diagnosis
- Allergy to essential oils
- Impaired sense of smell
- Dislike or discomfort with lavender scent
- Refusal to participate
- Respiratory disease (e.g., asthma, COPD)
- Peripheral vascular disease
- Neurological disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental (Lavender) Group
Patients in the aromatherapy group received lavender essential oil inhalation therapy, in which three drops of lavender oil were applied to a sterile sponge and held approximately 5 cm from the patient's nose for 5 minutes.
This distance was maintained to ensure standardization of the intervention.
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Patients in the aromatherapy group received lavender essential oil inhalation therapy, in which three drops of lavender oil were applied to a sterile sponge and held approximately 5 cm from the patient's nose for 5 minutes.
|
|
Experimental: Experiment (Music) Group
Patients in the music intervention group listened to relaxing classical music through headphones for 10 minutes in the waiting area before the angiography procedure.
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Patients in the music intervention group listened to relaxing classical music through headphones for 10 minutes in the waiting area before the angiography procedure.
|
|
Other: Control Group
Participants in the control group received routine care without any additional intervention.
|
Routine care before angiography includes patient assessment, ensuring fasting, establishing intravenous access, adjusting medication, and preparing the patient physically and psychologically for the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Information Form
Time Frame: First day
|
The Patient Information Form was developed by the researchers based on an extensive review of the literature.
The form included questions designed to collect information about the socio-demographic and clinical characteristics of the participants.
The variables included in the form were age, gender, education level, marital status, place of residence, income level, smoking status, presence of chronic disease, previous angiography experience, and other relevant health-related information.
|
First day
|
|
General Comfort Scale
Time Frame: First day
|
The scale is designed based on a taxonomic structure that includes three levels and four dimensions forming the theoretical components of comfort, and is used to determine needs and to evaluate the extent to which comfort-providing nursing interventions lead to an increase in expected comfort.
The scale is a four-point Likert type and contains a total of 48 items.
The response patterns of the scale, which consists of positive and negative items, are given in a mixed order.
Accordingly, a high score (4) in positive items indicates high comfort, and a low score (1) indicates low comfort.
In the evaluation of the scale, the obtained negative scores are reverse-coded and added to the positive items.
The highest total score that can be obtained from the scale is 192, and the lowest total score is 48.
|
First day
|
|
General Comfort Scale
Time Frame: Second day
|
The scale is designed based on a taxonomic structure that includes three levels and four dimensions forming the theoretical components of comfort, and is used to determine needs and to evaluate the extent to which comfort-providing nursing interventions lead to an increase in expected comfort.
The scale is a four-point Likert type and contains a total of 48 items.
The response patterns of the scale, which consists of positive and negative items, are given in a mixed order.
Accordingly, a high score (4) in positive items indicates high comfort, and a low score (1) indicates low comfort.
In the evaluation of the scale, the obtained negative scores are reverse-coded and added to the positive items.
The highest total score that can be obtained from the scale is 192, and the lowest total score is 48.
|
Second day
|
|
Visual Analog Scale for Pain
Time Frame: First day
|
The VAS, developed by Price et al. (1983), is commonly used in research to assess the intensity of pain as experienced by patients.
It is a reliable and valid instrument.
The scale consists of a 10-cm line, which can be either horizontal or vertical, with one end marked as "No Pain" (0) and the other as "Worst Pain" (10).
Patients are given clear instructions on how to use the VAS and are asked to mark the point on the line that best represents their level of pain.
The distance from the "No Pain" end to the patient's mark is then measured in centimeters and recorded.
The scale ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain.
|
First day
|
|
Visual Analog Scale for Pain
Time Frame: Second day
|
The VAS, developed by Price et al. (1983), is commonly used in research to assess the intensity of pain as experienced by patients.
It is a reliable and valid instrument.
The scale consists of a 10-cm line, which can be either horizontal or vertical, with one end marked as "No Pain" (0) and the other as "Worst Pain" (10).
Patients are given clear instructions on how to use the VAS and are asked to mark the point on the line that best represents their level of pain.
The distance from the "No Pain" end to the patient's mark is then measured in centimeters and recorded.
The scale ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain.
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Second day
|
|
Visual Analog Scale for Fear
Time Frame: First day
|
Fear levels were measured using a similar Visual Analog Scale, ranging from 0 to 10, where 0 indicates "no fear" and 10 represents "extreme fear".
Participants were asked to mark the point on the scale that best represented their fear level before the angiography procedure.
|
First day
|
|
Visual Analog Scale for Fear
Time Frame: Second day
|
Fear levels were measured using a similar Visual Analog Scale, ranging from 0 to 10, where 0 indicates "no fear" and 10 represents "extreme fear".
Participants were asked to mark the point on the scale that best represented their fear level before the angiography procedure.
|
Second day
|
|
Visual Analog Scale for Anxiety
Time Frame: First day
|
Participants' anxiety levels were also measured using a Visual Analog Scale ranging from 0 (no anxiety) to 10 (extreme anxiety).
The scale allows patients to subjectively evaluate the severity of their anxiety at the time of assessment.
|
First day
|
|
Visual Analog Scale for Anxiety
Time Frame: Second day
|
Participants' anxiety levels were also measured using a Visual Analog Scale ranging from 0 (no anxiety) to 10 (extreme anxiety).
The scale allows patients to subjectively evaluate the severity of their anxiety at the time of assessment.
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Second day
|
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State-Trait Anxiety Inventory
Time Frame: First day
|
The State Anxiety Scale is a highly sensitive tool for assessing rapidly changing emotional reactions.
It provides information about an individual's operational anxiety.
It is a four-point scale ranging from "none" to "completely."
The Trait Anxiety Scale, on the other hand, requires the individual to describe how they generally feel.
The State Anxiety Scale includes both direct and inverted statements.
Direct statements indicate negative emotions, while inverted statements indicate positive emotions.
The final value obtained is the individual's anxiety score.
In interpreting the scores, the total score obtained from both inventories ranges from 20 to 80.
A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.
|
First day
|
|
State-Trait Anxiety Inventory
Time Frame: Second day
|
The State Anxiety Scale is a highly sensitive tool for assessing rapidly changing emotional reactions.
It provides information about an individual's operational anxiety.
It is a four-point scale ranging from "none" to "completely."
The Trait Anxiety Scale, on the other hand, requires the individual to describe how they generally feel.
The State Anxiety Scale includes both direct and inverted statements.
Direct statements indicate negative emotions, while inverted statements indicate positive emotions.
The final value obtained is the individual's anxiety score.
In interpreting the scores, the total score obtained from both inventories ranges from 20 to 80.
A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.
|
Second day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: İNCİHAN KARAMAN, MsC, Cyprus Aydin University
Publications and helpful links
General Publications
- Amin, A., Amraei, M., Shahijan, M., Nadri, S., & Moradifar, N. (2021). The effects of aromatherapy on patients undergoing coronary angiography: A systematic review of clinical trials. Journal of Herbmed Pharmacology, 11(1), 1-9. https://doi.org/10.34172/jhp.2022.01 Auliya, K., Suryani, R., & Yudha, M. (2024). Implementasi Aromaterapi Mawar Untuk Mengurangi Kecemasan Pre Operasi Pada Pasien Sectio Caesarea Dengan Anestesi Spinal. Kolaborasi Jurnal Pengabdian Masyarakat, 4(5), 364-372. https://doi.org/10.56359/kolaborasi.v4i5.408 Borges, A. (2025). Lavender, Peppermint, Neroli, and Eucalyptus in the Modulation of Pain and Anxiety: A Critical Review of Aromatherapeutic Approaches. Brazilian Journal of Health Aromatherapy and Essential Oil, 2(1), bjhae24. https://doi.org/10.62435/2965-7253.bjhae.2025.bjhae24 Devi, S., Agustini, T., & Taqiyah, Y. (2023). Aromaterapi Lavender dalam Menurunkan Tingkat Kecemasan Pasien Pre Operasi Sectio Caesarea. Window of Nursing Journal, 153-159. https://doi.org/10.33096/won.v4i2.521 Dwitanta, S. (2024). AROMA THERAPY INTERVENTION TO IMPROVING SLEEP QUALITY IN PATIENTS WITH CARDIOVASCULAR PROBLEMS. Jurnal Keperawatan Malang, 9(2), 130-139. https://doi.org/10.36916/jkm.v9i2.271 Eslami, J., Ebrahimi, A., Hosseinkhani, A., Khazaei, Z., & Darvishi, I. (2018). The effect of aromatherapy using Lavender (Lavandula angustifolia Miller) and Citrus aurantium L. extracts to treat anxiety of patients undergoing laparoscopic cholecystectomy: A randomized clinical trial in Iran. Biomedical Research and Therapy, 5(3), 2096-2110. https://doi.org/10.15419/bmrat.v5i3.423 Eğilmez, O., Güven, M., Yılmaz, A., Güven, E., & Gündoğan, M. (2021). Investigation of the Effects of Lavender Oil Aromatherapy to Prevent Preoperative Anxiety in Patients Scheduled for Tympanoplasty. International J
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MUSIC AND AROMATHERAPY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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