Percutaneous Coronary InterventionNCT05514574
The Effect of Listening to Music and Stress Ball Application on Patients' Anxiety Level and Hemodynamic Parameters During PCI
A study testing Music and Stress ball in people with Percutaneous Coronary Intervention and Anxiety, run by Keriman Yildiz at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to determine the effects of listening to music and applying a stress ball on patients' anxiety level and hemodynamic parameters during percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Anxiety, Hemodynamics
- What is being tested?
- Music and Stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2022to 27 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older,
- Literate,
- Able to communicate verbally,
- Turkish speaking,
- No hearing or vision loss,
- No sensory or motor deficits in the hand or arm,
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- Percutaneous coronary intervention will be applied,
- intervention from the femoral artery,
- Voluntarily participated in the research,
- Patients signing the informed consent form will be included.
Who cannot join
- Under the age of 18,
- Not signing the informed consent form,
- Illiterate,
- Unable to speak Turkish,
- Unable to communicate verbally
- Those who have a neurological or psychiatric disease that prevents communication,
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- Hearing and sight impaired,
- Those who have had a mastectomy
- Those with arterio-venous fistula
- Percutaneous coronary intervention has been performed in the last 2 years,
- Restricted special groups (pregnant women, criminal convicts, etc.),
- Emergency cases where communication cannot be established,
- Those with equipment problems such as monitors and cuffs,
- Those who will be given sedatives during the procedure,
- Those who will be taking cardiovascular system medications other than routine practices during the procedure,
- Those who will be given oxygen during the procedure,
- Patients who are treated from a different artery other than the femoral artery will not be accepted.
- Criteria for exclusion from follow-up:
- Those who want to quit working,
- Those who give up listening to music,
- Those who give up using the stress ball,
- Those who were given cardiovascular system medications other than routine practices during the procedure,
- Those who underwent intervention from a different artery instead of the femoral artery,
- Those who do not want to wear headphones because they cannot hear the doctor's questions
- Those whose second measurements could not be taken because they were quickly removed from the interventional room,
- Those who underwent carotid artery angiography in addition to coronary artery,
- Those who give incorrect PCI history,
- Those who cannot listen to music or whose music is interrupted due to connection problems,
- Those whose intervention cannot be performed at the planned time due to urgent patient arrival,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Provincial Health Directorate Karamanoğlu Mehmetbey University Karaman Training and Research Hospital
Karaman, 70200
About this study
Official title: The Effect of Listening to Music and Stress Ball Application on Patients' Anxiety Level and Hemodynamic Parameters During Percutaneous Coronary Intervention
In this study, it was aimed to determine the effects of listening to music and applying a stress ball on patients' anxiety level and hemodynamic parameters during percutaneous coronary intervention (PCI).
Read the detailed description
Percutaneous coronary intervention causes patients to experience anxiety and change their hemodynamic parameters. In this study, it was aimed to determine the effects of listening to music and applying a stress ball on patients' anxiety level and hemodynamic parameters during percutaneous coronary intervention.
- Conditions
- Percutaneous Coronary Intervention, Anxiety, Hemodynamics
- Being tested
- Music, Stress ball
- Keywords
- percutaneous coronary intervention, anxiety, hemodynamics, music, stress ball
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
"hussoni duseni " music
Stress ballOther
Stress ball squeeze
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Patients (listening to music group) who are taken to the intervention table and placed on their backs by the team that will perform the intervention will be monitored. The hemodynamic parameters on the monitor screen will be recorded on the data collection form before and after percutaneous coronary intervention by the researcher KY. Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale before being taken to the intervention room for percutaneous coronary intervention (while in a bed or stretcher or wheelchair). Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale after leaving the intervention room (while on the bed or stretcher). During percutaneous coronary intervention; Except for routine treatment and care interventions, the patient will listen to music during the procedure. Receives: Other: Music |
| Stress ball | Experimental | Patients (stress ball group) who are taken to the intervention table and placed on their backs by the team that will perform the intervention will be monitored. The hemodynamic parameters on the monitor screen will be recorded on the data collection form before and after percutaneous coronary intervention by the researcher KY. Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale before being taken to the intervention room for percutaneous coronary intervention (while in a bed or stretcher or wheelchair). Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale after leaving the intervention room (while on the bed or stretcher). During percutaneous coronary intervention; Except for routine treatment and care interventions, the patient will stress ball will be applied during the procedure. Receives: Other: Stress ball |
| Control | No intervention | Patients (control group) who are taken to the intervention table and placed on their backs by the team that will perform the intervention will be monitored. The hemodynamic parameters on the monitor screen will be recorded on the data collection form before and after percutaneous coronary intervention by the researcher KY. Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale before being taken to the intervention room for percutaneous coronary intervention (while in a bed or stretcher or wheelchair). Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale after leaving the intervention room (while on the bed or stretcher). During percutaneous coronary intervention; No intervention will be performed except for routine treatment and care interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Score
Change in State Anxiety Score after intervention.
Measured: Each participant's State Anxiety score will be measured before and after admission to (twice-daily) the percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
Secondary outcomes (6)
Systolic Blood Pressure Value (mmHg)
Change in Systolic Blood Pressure Value after intervention.
Measured: Systolic Blood Pressure value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form
Diastolic Blood Pressure Value (mmHg)
Change in Diastolic Blood Pressure Value after intervention.
Measured: Diastolic Blood Pressure value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
Mean Arterial Pressure Value (mmHg)
Change in Mean Arterial Pressure Value after intervention.
Measured: Mean Arterial Pressure value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
Heart Rate/Minute Value
Change in Heart Rate/Minute Value after intervention.
Measured: Heart Rate/Minute value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
Respiratory Rate/Minute Value
Change in Respiratory Rate/Minute Value after intervention.
Measured: Respiratory Rate/Minute value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
Peripheral Oxygen Saturation (SpO2) Value
Change in Peripheral Oxygen Saturation Value after intervention.
Measured: Peripheral Oxygen Saturation value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start2 Aug 2022
- Primary completion22 Feb 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Prospective Non-Randomized Controlled Clinical Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keriman Yildiz
- Sponsor type
- University, hospital or other
- Collaborators
- Necmettin Erbakan University
- Responsible party
- Sponsor-investigator, Keriman Yildiz, Necmettin Erbakan University
- Investigators
- SERPİL YÜKSEL, PhD, Principal investigator, Necmettin Erbakan UniversityAHMET YILMAZ, PhD, Study director, Karamanoğlu Mehmetbey UniversityKERİMAN YILDIZ, MSc, Study director, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514574
- Sponsor's protocol ID
- KYildiz
- Status last verified
- Jan 2024
- First submitted
- 17 Aug 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: STUDY PROTOCOL
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Music and Stress Ball Application on Patients' Anxiety Level and Hemodynamic Parameters During Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT05514574
- Acronym / sponsor ID
- KYildiz
- Conditions
- Percutaneous Coronary Intervention, Anxiety, Hemodynamics
- Keywords
- percutaneous coronary intervention, anxiety, hemodynamics, music, stress ball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Keriman YildizUniversity, hospital or other
- Collaborators
- Necmettin Erbakan University
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 24 Aug 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.
In this study, it was aimed to determine the effects of listening to music and applying a stress ball on patients' anxiety level and hemodynamic parameters during percutaneous coronary intervention (PCI).
Detailed description
Percutaneous coronary intervention causes patients to experience anxiety and change their hemodynamic parameters. In this study, it was aimed to determine the effects of listening to music and applying a stress ball on patients' anxiety level and hemodynamic parameters during percutaneous coronary intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment Prospective Non-Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: MusicPatients (listening to music group) who are taken to the intervention table and placed on their backs by the team that will perform the intervention will be monitored. The hemodynamic parameters on the monitor screen will be recorded on the data collection form before and after percutaneous coronary intervention by the researcher KY. Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale before being taken to the intervention room for percutaneous coronary intervention (while in a bed or stretcher or wheelchair). Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale after leaving the intervention room (while on the bed or stretcher). During percutaneous coronary intervention; Except for routine treatment and care interventions, the patient will listen to music during the procedure. |
| Stress ball | Experimental | Other: Stress ballPatients (stress ball group) who are taken to the intervention table and placed on their backs by the team that will perform the intervention will be monitored. The hemodynamic parameters on the monitor screen will be recorded on the data collection form before and after percutaneous coronary intervention by the researcher KY. Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale before being taken to the intervention room for percutaneous coronary intervention (while in a bed or stretcher or wheelchair). Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale after leaving the intervention room (while on the bed or stretcher). During percutaneous coronary intervention; Except for routine treatment and care interventions, the patient will stress ball will be applied during the procedure. |
| Control | No intervention | –Patients (control group) who are taken to the intervention table and placed on their backs by the team that will perform the intervention will be monitored. The hemodynamic parameters on the monitor screen will be recorded on the data collection form before and after percutaneous coronary intervention by the researcher KY. Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale before being taken to the intervention room for percutaneous coronary intervention (while in a bed or stretcher or wheelchair). Anxiety levels of patients will be evaluated by the researcher KY with the State Anxiety Scale after leaving the intervention room (while on the bed or stretcher). During percutaneous coronary intervention; No intervention will be performed except for routine treatment and care interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years and older,
- Literate,
- Able to communicate verbally,
- Turkish speaking,
- No hearing or vision loss,
Key exclusion criteria (29 listed)
- Under the age of 18,
- Not signing the informed consent form,
- Illiterate,
- Unable to speak Turkish,
- Unable to communicate verbally
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"hussoni duseni " music | Other | Music |
| Stress ballStress ball squeeze | Other | Stress ball |
Primary outcome
State Anxiety Score
Time frame: Each participant's State Anxiety score will be measured before and after admission to (twice-daily) the percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
Change in State Anxiety Score after intervention.
6 secondary outcomes
Systolic Blood Pressure Value (mmHg)
Time frame: Systolic Blood Pressure value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form
Diastolic Blood Pressure Value (mmHg)
Time frame: Diastolic Blood Pressure value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
Mean Arterial Pressure Value (mmHg)
Time frame: Mean Arterial Pressure value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
Heart Rate/Minute Value
Time frame: Heart Rate/Minute value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
Respiratory Rate/Minute Value
Time frame: Respiratory Rate/Minute value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
Peripheral Oxygen Saturation (SpO2) Value
Time frame: Peripheral Oxygen Saturation value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
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 17 Jan 2024.
- Individual participant dataSharing planned: Yes. STUDY PROTOCOL
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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.
SERPİL YÜKSEL, PhD principal investigator
Necmettin Erbakan University
AHMET YILMAZ, PhD study director
Karamanoğlu Mehmetbey University
KERİMAN YILDIZ, MSc study director
Necmettin Erbakan University
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 and Stress ball in people with Percutaneous Coronary Intervention and Anxiety, run by Keriman Yildiz 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 10 inclusion and 29 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 17 Jan 2024. 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?
State Anxiety Score (time frame: Each participant's State Anxiety score will be measured before and after admission to (twice-daily) the percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.). 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 17 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.