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

Sponsor

Keriman Yildiz (Other)

Overall Status

Recruiting

CT.gov ID

NCT05514574

Collaborator

Necmettin Erbakan University (Other)

183

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Coronary Intervention Anxiety Hemodynamics	Other: Music Other: Stress ball	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

183 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel Assignment Prospective Randomized Controlled Clinical TrialParallel Assignment Prospective Randomized Controlled Clinical Trial

Masking:

Single (Outcomes Assessor)

Masking Description:

Patients and their relatives, clinical staff, will be blinded to the investigator (KY) group assignment. Evaluation of the data will be done by a blinded technique by a biostatistician not involved in the study and blinded to group assignment.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 2, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

State Anxiety Score [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.

Secondary Outcome Measures

Systolic Blood Pressure Value (mmHg) [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]
Change in Systolic Blood Pressure Value after intervention.
Diastolic Blood Pressure Value (mmHg) [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.]
Change in Diastolic Blood Pressure Value after intervention.
Mean Arterial Pressure Value (mmHg) [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.]
Change in Mean Arterial Pressure Value after intervention.
Heart Rate/Minute Value [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.]
Change in Heart Rate/Minute Value after intervention.
Respiratory Rate/Minute Value [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.]
Change in Respiratory Rate/Minute Value after intervention.
Peripheral Oxygen Saturation (SpO2) Value [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.]
Change in Peripheral Oxygen Saturation Value after intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Psychiatric illness that prevents communication,
Hearing and sight impaired,
Sensory and motor loss in the hand or arm,
Percutaneous coronary intervention has been performed in the last 2 years,
Sedation during the procedure, cardiovascular system drug administration, administration of Oxygen
Patients who are treated from a different artery other than the femoral artery will not be accepted.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karaman Provincial Health Directorate Karamanoğlu Mehmetbey University Karaman Training and Research Hospital	Karaman		Turkey	70200

Sponsors and Collaborators

Keriman Yildiz
Necmettin Erbakan University

Investigators

Principal Investigator: SERPİL YÜKSEL, PhD, Necmettin Erbakan University
Study Director: AHMET YILMAZ, PhD, Karamanoğlu Mehmetbey University
Study Director: KERİMAN YILDIZ, MSc, Necmettin Erbakan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Keriman Yildiz, Study Director, Necmettin Erbakan University

ClinicalTrials.gov Identifier:

NCT05514574

Other Study ID Numbers:

KYildiz

First Posted:

Aug 24, 2022

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Keriman Yildiz, Study Director, Necmettin Erbakan University

percutaneous coronary intervention

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Aug 24, 2022