Clinical trial NCT05514574: The Effect of Listening to Music and Stress Ball Application on Patients' Anxiety Level and Hemodynamic Parameters During PCI
Official title: The Effect of Listening to Music and Stress Ball Application on Patients' Anxiety Level and Hemodynamic Parameters During Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Coronary Intervention
Anxiety
Hemodynamics
Keywords: percutaneous coronary intervention
anxiety
hemodynamics
music
stress ball
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
Collaborators: name: Necmettin Erbakan University
First posted: 2022-08-24
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Prospective Non-Randomized Controlled Clinical Trial
Primary purpose: PREVENTION

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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,
* 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.

Exclusion Criteria:

* 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,
* 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,

Primary outcomes:
measure: State Anxiety Score
timeFrame: 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:
measure: Systolic Blood Pressure Value (mmHg)
timeFrame: 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
measure: Diastolic Blood Pressure Value (mmHg)
timeFrame: 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.
measure: Mean Arterial Pressure Value (mmHg)
timeFrame: 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.
measure: Heart Rate/Minute Value
timeFrame: 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.
measure: Respiratory Rate/Minute Value
timeFrame: 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.
measure: Peripheral Oxygen Saturation (SpO2) Value
timeFrame: 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.
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Provincial Health Directorate Karamanoğlu Mehmetbey University Karaman Training and Research Hospital
Study officials:
affiliation: Necmettin Erbakan University
name: SERPİL YÜKSEL, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karamanoğlu Mehmetbey University
name: AHMET YILMAZ, PhD
role: STUDY_DIRECTOR
affiliation: Necmettin Erbakan University
name: KERİMAN YILDIZ, MSc
role: STUDY_DIRECTOR
References: