Coronary Artery DiseaseNCT04651075
Music Listenıng And Training Before Coronary Angıography
A study testing music listening and individual training in people with Coronary Artery Disease and Anxiety, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of education and music listening on the anxiety and physiological parameters experienced by individuals undergoing elective coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Anxiety, Music
- What is being tested?
- music listening and individual training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 1 Apr 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Applying femoral CAG electively,
- The first time CAG will be held,
- Performing the CAG procedure for diagnostic purposes,
- Not trained on the CAG process,
- Volunteering to participate in the study,
- No problem in verbal communication,
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- No hearing loss,
- Being able to read and write,
- Has not been diagnosed with psychiatric illness,
- Being conscious,
- Being 18 or older.
Who cannot join
- Radial application of CAG,
- Previously performing coronary angiography,
- Performing the CAG procedure for therapeutic purposes (stent, balloon, etc.),
- Having received training on the KAG process,
- Does not want to participate in the study
- Problems in verbal communication,
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- Hearing loss,
- Psychiatric illness is found.
- Consciousness is closed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant İzzet Baysal University
Bolu, Merkez, 14100_
About this study
Official title: Effects On Physıological Parameters And Anxiety Of Related Musıc And Informatıon Training Before Coronary Angiography
The aim of this study was to investigate the effects of education and music listening on the anxiety and physiological parameters experienced by individuals undergoing elective coronary angiography.
Read the detailed description
The aim of this study was to investigate the effects of education and music listening on the anxiety and physiological parameters experienced by individuals undergoing elective coronary angiography.
The population of the study consisted of individuals undergoing elective coronary angiography in the Cardiology Department of Abant İzzet Baysal University İzzet Baysal Training and Research Hospital. The study was conducted in a randomized controlled manner with three groups: 34 individuals in music listening group (M1), 34 individuals in information training group (M2) and 34 subjects in control group. In order to collect data, CAG (Coronary angiography) Procedure Training Form, Patient Identification Form, Physiological Parameters Form and Visual Analogue Scale and Spielberg State and Trait Anxiety Scale were used. Data were collected by face to face interview technique. Descriptive statistics, Independet Simple test, Paired sample t test, Kruskall Wallis, Mann Whitney U test and Wilcoxon signed rank test were used in the analysis of the data and the significance level was accepted as p <0.05.
- Conditions
- Coronary Artery Disease, Anxiety, Music, Education
- Being tested
- music listening, individual training
- Keywords
- Coronary Angiography, Teaching, Music theraphy, Anxiety, Nursing care
- Medical subject headings
- Coronary Artery Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music listeningOther
The music selected by the participants was played to the music listening group.
individual trainingOther
Individual training group was trained on coronary angiography.
| Study group | Role | What they receive |
|---|---|---|
| music theraphy | Experimental | One of the 4 music genres (Turkish Folk, Classical, Turkish Art and Sufi Music), which was determined by the researcher by scanning the literature 30 minutes before the CAG procedure, and the expert opinion was taken to the participants in this group was played with a 5-minute headset. The musical genres were arranged in instrumental, nonverbal, 70 decibels in terms of rhythm and duration and played according to the individual's choice. Receives: Other: music listening |
| information education | Experimental | Participants in this group were trained to inform them about CAG in visual, audio and written form. Information training was provided by the researcher 30 minutes before the CAG procedure after the outpatient clinic controls of the patient. Information education prepared by the researcher by scanning the literature and getting expert opinion; It includes 7 minutes of video explanation about the CAG process, discussion after video watching, question and answer, and the delivery of a training book prepared in written form. Receives: Other: individual training |
| nursing care | No intervention | Individuals in this group received routine nursing care and no intervention was made by the researcher. In routine nursing care for individuals who will receive CAG procedure in the clinic; Preparation for the CAG procedure, which involves opening the vascular access and dressing the surgical gown, is included in the pre-and post-procedure routine once and more frequently when there are deviations from normal, and if the patient asks questions about the procedure, measurement of blood pressure, heart rate and oxygen saturation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
means of subjective anxiety scores
Spielberg State- Trait Anxiety Scale. The total score between 0-19 obtained from the state anxiety scale shows that there is no anxiety, the total score between 20-39 indicates mild, the average score between 40-59 indicates moderate, and the total score between 60-79 indicates severe anxiety, and over 60 points are needed for professional help. The scores obtained from the trait anxiety scale vary between 20 and 80. A high score means a high and a low level means anxiety.
Measured: up to 45 minutes
Secondary outcomes (1)
means of subjective pain scores
visual analog scale. It consists of a straight line with endpoints that define end limits such as "no pain" and "pain as bad as possible". The patient is asked to mark the level of pain on the line between the two endpoints.
Measured: up to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Apr 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Parallel groups
- Model description
- There are 3 groups as intervention and control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651075
- Sponsor's protocol ID
- AIBU-HSF-AYN-01
- Status last verified
- Apr 2022
- First submitted
- 26 Jun 2020
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects On Physıological Parameters And Anxiety Of Related Musıc And Informatıon Training Before Coronary Angiography
- ClinicalTrials.gov ID
- NCT04651075
- Acronym / sponsor ID
- AIBU-HSF-AYN-01
- Conditions
- Coronary Artery Disease, Anxiety, Music, Education
- Keywords
- Coronary Angiography, Teaching, Music theraphy, Anxiety, Nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 3 Dec 2020 (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.
The aim of this study was to investigate the effects of education and music listening on the anxiety and physiological parameters experienced by individuals undergoing elective coronary angiography.
Detailed description
The aim of this study was to investigate the effects of education and music listening on the anxiety and physiological parameters experienced by individuals undergoing elective coronary angiography.
The population of the study consisted of individuals undergoing elective coronary angiography in the Cardiology Department of Abant İzzet Baysal University İzzet Baysal Training and Research Hospital. The study was conducted in a randomized controlled manner with three groups: 34 individuals in music listening group (M1), 34 individuals in information training group (M2) and 34 subjects in control group. In order to collect data, CAG (Coronary angiography) Procedure Training Form, Patient Identification Form, Physiological Parameters Form and Visual Analogue Scale and Spielberg State and Trait Anxiety Scale were used. Data were collected by face to face interview technique. Descriptive statistics, Independet Simple test, Paired sample t test, Kruskall Wallis, Mann Whitney U test and Wilcoxon signed rank test were used in the analysis of the data and the significance level was accepted as p <0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- There are 3 groups as intervention and control
| Arm | Type | Receives |
|---|---|---|
| music theraphy | Experimental | Other: music listeningOne of the 4 music genres (Turkish Folk, Classical, Turkish Art and Sufi Music), which was determined by the researcher by scanning the literature 30 minutes before the CAG procedure, and the expert opinion was taken to the participants in this group was played with a 5-minute headset. The musical genres were arranged in instrumental, nonverbal, 70 decibels in terms of rhythm and duration and played according to the individual's choice. |
| information education | Experimental | Other: individual trainingParticipants in this group were trained to inform them about CAG in visual, audio and written form. Information training was provided by the researcher 30 minutes before the CAG procedure after the outpatient clinic controls of the patient. Information education prepared by the researcher by scanning the literature and getting expert opinion; It includes 7 minutes of video explanation about the CAG process, discussion after video watching, question and answer, and the delivery of a training book prepared in written form. |
| nursing care | No intervention | –Individuals in this group received routine nursing care and no intervention was made by the researcher. In routine nursing care for individuals who will receive CAG procedure in the clinic; Preparation for the CAG procedure, which involves opening the vascular access and dressing the surgical gown, is included in the pre-and post-procedure routine once and more frequently when there are deviations from normal, and if the patient asks questions about the procedure, measurement of blood pressure, heart rate and oxygen saturation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Applying femoral CAG electively,
- The first time CAG will be held,
- Performing the CAG procedure for diagnostic purposes,
- Not trained on the CAG process,
- Volunteering to participate in the study,
Key exclusion criteria (9 listed)
- Radial application of CAG,
- Previously performing coronary angiography,
- Performing the CAG procedure for therapeutic purposes (stent, balloon, etc.),
- Having received training on the KAG process,
- Does not want to participate in the study
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 |
|---|---|---|
| music listeningThe music selected by the participants was played to the music listening group. | Other | music theraphy |
| individual trainingIndividual training group was trained on coronary angiography. | Other | information education |
Primary outcome
means of subjective anxiety scores
Time frame: up to 45 minutes
Spielberg State- Trait Anxiety Scale. The total score between 0-19 obtained from the state anxiety scale shows that there is no anxiety, the total score between 20-39 indicates mild, the average score between 40-59 indicates moderate, and the total score between 60-79 indicates severe anxiety, and over 60 points are needed for professional help. The scores obtained from the trait anxiety scale vary between 20 and 80. A high score means a high and a low level means anxiety.
1 secondary outcome
means of subjective pain scores
Time frame: up to 45 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 21 Apr 2022.
- Individual participant dataSharing planned: No
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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 music listening and individual training in people with Coronary Artery Disease and Anxiety, run by Abant Izzet Baysal 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 11 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 21 Apr 2022. 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?
means of subjective anxiety scores (time frame: up to 45 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 21 Apr 2022.