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

NCT ID: NCT05514574

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2023-10-27

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.

Conditions

Percutaneous Coronary Intervention; Anxiety; Hemodynamics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Music

Intervention Type: OTHER

"hussoni duseni " music

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.

Group Type: EXPERIMENTAL

Stress ball

Intervention Type: OTHER

Stress ball squeeze

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music

"hussoni duseni " music

Intervention Type: OTHER

Stress ball

Stress ball squeeze

Intervention Type: OTHER

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Necmettin Erbakan University

OTHER

Sponsor Role: collaborator

Keriman Yildiz

OTHER

Sponsor Role: lead

Responsible Party

Keriman Yildiz

Study Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

SERPİL YÜKSEL, PhD

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan University

AHMET YILMAZ, PhD

Role: STUDY_DIRECTOR

Karamanoğlu Mehmetbey University

KERİMAN YILDIZ, MSc

Role: STUDY_DIRECTOR

Necmettin Erbakan University

Locations

Karaman Provincial Health Directorate Karamanoğlu Mehmetbey University Karaman Training and Research Hospital

Karaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KYildiz

Identifier Type: -

Identifier Source: org_study_id