Anxiety StateNCT04276506
Effect of Information Given and Music on the Care of Patient Who Will Undergo Coronary Angiography
A study testing music group and information group in people with Anxiety State and Invasive Procedure, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Today, due to the increasing frequency of cardiovascular diseases the number of coronary angiography performed has also risen. This invasive procedure has an effect on patients which causes anxiety. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety State, Invasive Procedure
- What is being tested?
- music group and information group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteCyprus
- Study dates
- 10 Nov 2019to 10 Mar 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult
- patients who undergoing coronary angiography first time
- able to speak and understand turkish
- people informed clearly by the investigator
Who cannot join
- having any hearing and visual problems
- being on psychiatric medications
- emergency cases
- patient under legally protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Music and Giving Information on the Patient Care Who Undergoing Coronary Angiography
Today, due to the increasing frequency of cardiovascular diseases the number of coronary angiography performed has also risen. This invasive procedure has an effect on patients which causes anxiety. Its important to determine of the level of anxiety so experienced nurses carried out various interventions to reduce anxiety.
This study aims to determine the effect of listening music and getting information on the level of anxiety and vital signs of the patients who are planned to undergo coronary angiography.
For this purpose, calming music which is suitable for the heart rhythm and booklets which is prepared with various visuals will be used. In the study, apart from a control group that routine clinical procedures will be applied, there will be two more groups which are called as music and information groups. Patients' participation in these groups will be distributed randomly by computer.
Read the detailed description
The patients will be included to this study who will undergo coronary angiography first time and admitted to hospital by appointment.
Inserting IV canulla, taking and recording vital signs, and informing about angiography are routine procedures for patients who are admitted to hospital for coronary angiography. These procedures will also be applied to the patient groups involved in the study.
Patients will be assigned to the groups in accordance with the randomization table. After explaining the purpose and method of the study to the patients, their consent will be obtained.In this experimental study all datas will be collected by Descriptive Characteristics Form, Vital Findings Follow-Up Form and The State-Continuity Anxiety Inventory.
Vital Signs Follow-Up Form will be recorded according to patients' findings, such as heart rate per minute, blood pressure as mmHg and respiratory rate per minute both before and after angiography.
The State-Continuity Anxiety Inventory will be applied before angiography to determine the anxiety level of the patients. After the angiography, the state anxiety inventory will be repeated.The information group; A visual information booklet which is prepared by the researcher will be used. In the booklet; Information about coronary arteries, angiography laboratory features, patient preparation procedure and post-procedure are explained with various visuals. The booklet which contains researchers telephone numbers will be given to patients, when they come to hospital to get an angiography appointment. The patients will be asked to read the booklet until the day of angiography. If patients need to ask some questions, they will be able to reach the researchers within specified hours.
The Music group; A soothing type of music including five kinds sounds of nature which suitable for heart rate was selected and recorded on MP3. When they arrive hospital for angiography they will be explained how to use MP3 player and headset in the room. All music stored on the MP3 player will be played to the patient for five to ten seconds. They will be asked to choose their preferred music. The patient will listen the music which is chosen for 30 minutes via headset. In order to prevent contamination, disposable ear cups will be used for each patient.
- Conditions
- Anxiety State, Invasive Procedure
- Being tested
- music group, information group
- Keywords
- Anxiety, Coronary Angiography, Nursing, Music, Visual Information, Physiological parameters
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music groupOther
to reduce anxiety, some selected music pieces will have patients listened by headset.
information groupOther
A visual information booklet which is prepared by the researchers will be used
| Study group | Role | What they receive |
|---|---|---|
| information booklet group | Experimental | information session before the coronary angiography Receives: Other: information group |
| music group | Experimental | music session before the coronary angiography Receives: Other: music group |
| control group | No intervention | No information or music session before the coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
State anxiety level
Use of the State-Trait Anxiety Inventory (STAI) to assess the level of anxiety
Measured: 1 day
Secondary outcomes (3)
heart rate
beats per minute
Measured: 1 day
respiratory rate
breaths per minute
Measured: 1 day
blood pressure
mmHg
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start10 Nov 2019
- Primary completion10 Jan 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies 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
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Handan Sezgin, Assist Prof., Study director, Eastern Mediterranean University Health Science FacultyNurdan Yıldız, Msc, Principal investigator, Eastern Mediterranean University Health Science Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276506
- Sponsor's protocol ID
- EasternMUU
- Status last verified
- Jan 2020
- First submitted
- 27 Jan 2020
- Last updated
- 28 Sep 2020
- 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 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Music and Giving Information on the Patient Care Who Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT04276506
- Acronym / sponsor ID
- EasternMUU
- Conditions
- Anxiety State, Invasive Procedure
- Keywords
- Anxiety, Coronary Angiography, Nursing, Music, Visual Information, Physiological parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 19 Feb 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.
Today, due to the increasing frequency of cardiovascular diseases the number of coronary angiography performed has also risen. This invasive procedure has an effect on patients which causes anxiety. Its important to determine of the level of anxiety so experienced nurses carried out various interventions to reduce anxiety.
This study aims to determine the effect of listening music and getting information on the level of anxiety and vital signs of the patients who are planned to undergo coronary angiography.
For this purpose, calming music which is suitable for the heart rhythm and booklets which is prepared with various visuals will be used. In the study, apart from a control group that routine clinical procedures will be applied, there will be two more groups which are called as music and information groups. Patients' participation in these groups will be distributed randomly by computer.
Detailed description
The patients will be included to this study who will undergo coronary angiography first time and admitted to hospital by appointment.
Inserting IV canulla, taking and recording vital signs, and informing about angiography are routine procedures for patients who are admitted to hospital for coronary angiography. These procedures will also be applied to the patient groups involved in the study.
Patients will be assigned to the groups in accordance with the randomization table. After explaining the purpose and method of the study to the patients, their consent will be obtained.In this experimental study all datas will be collected by Descriptive Characteristics Form, Vital Findings Follow-Up Form and The State-Continuity Anxiety Inventory.
Vital Signs Follow-Up Form will be recorded according to patients' findings, such as heart rate per minute, blood pressure as mmHg and respiratory rate per minute both before and after angiography.
The State-Continuity Anxiety Inventory will be applied before angiography to determine the anxiety level of the patients. After the angiography, the state anxiety inventory will be repeated.The information group; A visual information booklet which is prepared by the researcher will be used. In the booklet; Information about coronary arteries, angiography laboratory features, patient preparation procedure and post-procedure are explained with various visuals. The booklet which contains researchers telephone numbers will be given to patients, when they come to hospital to get an angiography appointment. The patients will be asked to read the booklet until the day of angiography. If patients need to ask some questions, they will be able to reach the researchers within specified hours.
The Music group; A soothing type of music including five kinds sounds of nature which suitable for heart rate was selected and recorded on MP3. When they arrive hospital for angiography they will be explained how to use MP3 player and headset in the room. All music stored on the MP3 player will be played to the patient for five to ten seconds. They will be asked to choose their preferred music. The patient will listen the music which is chosen for 30 minutes via headset. In order to prevent contamination, disposable ear cups will be used for each patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| information booklet group | Experimental | Other: information groupinformation session before the coronary angiography |
| music group | Experimental | Other: music groupmusic session before the coronary angiography |
| control group | No intervention | –No information or music session before the coronary angiography |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult
- patients who undergoing coronary angiography first time
- able to speak and understand turkish
- people informed clearly by the investigator
Key exclusion criteria (4 listed)
- having any hearing and visual problems
- being on psychiatric medications
- emergency cases
- patient under legally protection
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 groupto reduce anxiety, some selected music pieces will have patients listened by headset. | Other | music group |
| information groupA visual information booklet which is prepared by the researchers will be used | Other | information booklet group |
Primary outcome
State anxiety level
Time frame: 1 day
Use of the State-Trait Anxiety Inventory (STAI) to assess the level of anxiety
3 secondary outcomes
heart rate
Time frame: 1 day
respiratory rate
Time frame: 1 day
blood pressure
Time frame: 1 day
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 28 Sep 2020.
- 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.
Handan Sezgin, Assist Prof. study director
Eastern Mediterranean University Health Science Faculty
Nurdan Yıldız, Msc principal investigator
Eastern Mediterranean University Health Science Faculty
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 group and information group in people with Anxiety State and Invasive Procedure, run by Eastern Mediterranean University at 1 site in Cyprus.
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 4 inclusion and 4 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 28 Sep 2020. 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 Cyprus. 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?
State anxiety level (time frame: 1 day). 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 28 Sep 2020.