Coronary AngiographyNCT06755268
Effect of Music on Coronary Angiography
A study testing listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music in people with Coronary Angiography and Hemodynamic Parameters, run by Özlem Canbolat at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted in a randomized, controlled experimental design to examine the effect of music on comfort, anxiety and hemodynamic parameters during coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography, Hemodynamic Parameters, Comfort
- What is being tested?
- listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older
- Being at least literate
- Having no mental and cognitive competence
- Understanding and speaking Turkish
- Having a planned coronary angiography
- Performing for diagnostic purposes
Who cannot join
- Having visual and hearing impairment
- Having a psychiatric diagnosis
- Using psychiatric medication (tranquilizers, etc.)
- Using anxiety medication in the last 6 months
- Having had coronary angiography before
- The coronary angiography procedure is being performed for therapeutic purposes (stent, balloon, etc.)
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- An unexpected complication during coronary angiography (arrhythmia, MI, bleeding, etc.)
- coronary angiographyprocedure started for diagnostic purposes and stent and/or balloon procedures were applied during the procedure
- Data collection forms were not filled out by the participant after coronary angiography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Music on Comfort, Anxiety and Hemodynamic Parameters During Coronary Angiography
This study was conducted in a randomized, controlled experimental design to examine the effect of music on comfort, anxiety and hemodynamic parameters during coronary angiography. The research was conducted with 78 patients (39 intervention and 39 control groups) who were processed in the Coronary Angiography Laboratory of Necmettin Erbakan Training and Research Hospital between February and June 2024. The intervention group listened to nature sounds based music during the angiography procedure, but no intervention was made to the control group. "Introductory Information Form," "State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form" were used to collect the data.
- Being tested
- listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music
- Keywords
- Anxiety, Comfort, Coronary angiography, Hemodynamic parameters, Nursing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based musicOther
Listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music during the angiography procedure.
| Study group | Role | What they receive |
|---|---|---|
| Application Group | Experimental | After explaining the purpose of the study and the way it was applied to patients in the music group, Introductory Information Form, State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form were applied. The intervention group listened to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music during the angiography procedure.Music was played to the intervention group via a loudspeaker placed in the coronary angiography laboratory.The intervention group was reapplied the State Anxiety Scale, General Comfort Scale and Hemodynamic Parameters Record Form after the angiography procedure. Receives: Other: listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music |
| Control Group | No intervention | After explaining the purpose of the study and the way it was applied to patients in the control group, Introductory Information Form, State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form were applied. No application was be made to the control group. The control group was reapplied the State Anxiety Scale, General Comfort Scale and Hemodynamic Parameters Record Form after the angiography procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Comfort Scale
Scores from the scale range from 48 to 192, and the higher the score, the higher the comfort level.
Measured: before the angiography procedure and after the angiography procedure (average of 15 minutes)
Secondary outcomes (1)
State Anxiety Scale
Scores from the scale range from 20 to 80, and the higher the score, the higher the anxiety level.
Measured: before the angiography procedure and after the angiography procedure (average of 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Feb 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngiographyStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Özlem Canbolat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Özlem Canbolat, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755268
- Sponsor's protocol ID
- E-77082166-302.08.01-850481
- Status last verified
- Jul 2024
- First submitted
- 24 Sep 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music on Comfort, Anxiety and Hemodynamic Parameters During Coronary Angiography
- ClinicalTrials.gov ID
- NCT06755268
- Acronym / sponsor ID
- E-77082166-302.08.01-850481
- Keywords
- Anxiety, Comfort, Coronary angiography, Hemodynamic parameters, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Özlem CanbolatUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 1 Jan 2025 (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.
This study was conducted in a randomized, controlled experimental design to examine the effect of music on comfort, anxiety and hemodynamic parameters during coronary angiography. The research was conducted with 78 patients (39 intervention and 39 control groups) who were processed in the Coronary Angiography Laboratory of Necmettin Erbakan Training and Research Hospital between February and June 2024. The intervention group listened to nature sounds based music during the angiography procedure, but no intervention was made to the control group. "Introductory Information Form," "State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form" were used to collect the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application Group | Experimental | Other: listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based musicAfter explaining the purpose of the study and the way it was applied to patients in the music group, Introductory Information Form, State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form were applied. The intervention group listened to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music during the angiography procedure.Music was played to the intervention group via a loudspeaker placed in the coronary angiography laboratory.The intervention group was reapplied the State Anxiety Scale, General Comfort Scale and Hemodynamic Parameters Record Form after the angiography procedure. |
| Control Group | No intervention | –After explaining the purpose of the study and the way it was applied to patients in the control group, Introductory Information Form, State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form were applied. No application was be made to the control group. The control group was reapplied the State Anxiety Scale, General Comfort Scale and Hemodynamic Parameters Record Form after the angiography procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being 18 years of age or older
- Being at least literate
- Having no mental and cognitive competence
- Understanding and speaking Turkish
- Having a planned coronary angiography
Key exclusion criteria (9 listed)
- Having visual and hearing impairment
- Having a psychiatric diagnosis
- Using psychiatric medication (tranquilizers, etc.)
- Using anxiety medication in the last 6 months
- Having had coronary angiography before
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 |
|---|---|---|
| listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based musicListening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music during the angiography procedure. | Other | Application Group |
Primary outcome
General Comfort Scale
Time frame: before the angiography procedure and after the angiography procedure (average of 15 minutes)
Scores from the scale range from 48 to 192, and the higher the score, the higher the comfort level.
1 secondary outcome
State Anxiety Scale
Time frame: before the angiography procedure and after the angiography procedure (average of 15 minutes)
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 1 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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 listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music in people with Coronary Angiography and Hemodynamic Parameters, run by Özlem Canbolat 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 6 inclusion and 9 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 1 Jan 2025. 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?
General Comfort Scale (time frame: before the angiography procedure and after the angiography procedure (average of 15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2025.