The Effect of Listening to Music and Stress Ball Application on Patients' Anxiety Level and Hemodynamic Parameters During PCI

Anxiety Clinical Trial

Official title:

The Effect of Listening to Music and Stress Ball Application on Patients' Anxiety Level and Hemodynamic Parameters During Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05514574
• Other study ID #: KYildiz
• Status: Completed
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: October 27, 2023

Study information

• Verified date: January 2024
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: October 27, 2023
• Est. primary completion date: February 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Hemodynamics
• Percutaneous Coronary Intervention

Intervention

Other:
• Music
"hussoni duseni " music
• Stress ball
Stress ball squeeze

Locations

Country	Name	City	State
Turkey	Karaman Provincial Health Directorate Karamanoglu Mehmetbey University Karaman Training and Research Hospital	Karaman

Sponsors (2)

Lead Sponsor	Collaborator
Keriman Yildiz	Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State Anxiety Score	Change in State Anxiety Score after intervention.	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	Systolic Blood Pressure Value (mmHg)	Change in Systolic Blood Pressure Value after intervention.	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
Secondary	Diastolic Blood Pressure Value (mmHg)	Change in Diastolic Blood Pressure Value after intervention.	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.
Secondary	Mean Arterial Pressure Value (mmHg)	Change in Mean Arterial Pressure Value after intervention.	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.
Secondary	Heart Rate/Minute Value	Change in Heart Rate/Minute Value after intervention.	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.
Secondary	Respiratory Rate/Minute Value	Change in Respiratory Rate/Minute Value after intervention.	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.
Secondary	Peripheral Oxygen Saturation (SpO2) Value	Change in Peripheral Oxygen Saturation Value after intervention.	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.