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

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).

Study Overview

• Status: Completed
• Conditions: Anxiety; Percutaneous Coronary Intervention; Hemodynamics
• Intervention / Treatment: Other: Music; Other: Stress ball

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 Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Karaman Provincial Health Directorate Karamanoğlu Mehmetbey University Karaman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music; 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.	Other: Music; "hussoni duseni " music
Experimental: Stress ball; 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.	Other: Stress ball; Stress ball squeeze
No Intervention: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Keriman Yildiz
• Collaborators: Necmettin Erbakan University
• Investigators: Study Director: AHMET YILMAZ, PhD, Karamanoglu Mehmetbey University; Study Director: KERİMAN YILDIZ, MSc, Necmettin Erbakan University; Principal Investigator: Serpil YÜKSEL, PhD, Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Actual): February 22, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 13, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; anxiety; music; hemodynamics; stress ball
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: KYildiz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: STUDY PROTOCOL
• IPD Sharing Time Frame: After December 1, 2024
• IPD Sharing Access Criteria: Anyone who wishes to access the data. Study Protocol.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No