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

Primary Purpose

Percutaneous Coronary Intervention, Anxiety, Hemodynamics

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music
Stress ball
Sponsored by
Keriman Yildiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Percutaneous Coronary Intervention focused on measuring percutaneous coronary intervention, anxiety, hemodynamics, music, stress ball

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Karaman Provincial Health Directorate Karamanoğlu Mehmetbey University Karaman Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Music

Stress ball

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

State Anxiety Score
Change in State Anxiety Score after intervention.

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2022
Last Updated
August 22, 2022
Sponsor
Keriman Yildiz
Collaborators
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT05514574
Brief Title
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: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Keriman Yildiz
Collaborators
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Coronary Intervention, Anxiety, Hemodynamics
Keywords
percutaneous coronary intervention, anxiety, hemodynamics, music, stress ball

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Prospective Randomized Controlled Clinical Trial
Masking
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.
Allocation
Randomized
Enrollment
183 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music
Arm Type
Experimental
Arm Description
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.
Arm Title
Stress ball
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
"hussoni duseni " music
Intervention Type
Other
Intervention Name(s)
Stress ball
Intervention Description
Stress ball squeeze
Primary Outcome Measure Information:
Title
State Anxiety Score
Description
Change in State Anxiety Score after intervention.
Time Frame
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 Measure Information:
Title
Systolic Blood Pressure Value (mmHg)
Description
Change in Systolic Blood Pressure Value after intervention.
Time Frame
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
Title
Diastolic Blood Pressure Value (mmHg)
Description
Change in Diastolic Blood Pressure Value after intervention.
Time Frame
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.
Title
Mean Arterial Pressure Value (mmHg)
Description
Change in Mean Arterial Pressure Value after intervention.
Time Frame
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.
Title
Heart Rate/Minute Value
Description
Change in Heart Rate/Minute Value after intervention.
Time Frame
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.
Title
Respiratory Rate/Minute Value
Description
Change in Respiratory Rate/Minute Value after intervention.
Time Frame
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.
Title
Peripheral Oxygen Saturation (SpO2) Value
Description
Change in Peripheral Oxygen Saturation Value after intervention.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KERİMAN YILDIZ, MSc
Phone
+905333502357
Email
kerimanyildiz.ky70@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
SERPİL YÜKSEL, PhD
Phone
+905052933760
Email
syuksel@erbakan.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SERPİL YÜKSEL, PhD
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AHMET YILMAZ, PhD
Organizational Affiliation
Karamanoğlu Mehmetbey University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
KERİMAN YILDIZ, MSc
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Study Director
Facility Information:
Facility Name
Karaman Provincial Health Directorate Karamanoğlu Mehmetbey University Karaman Training and Research Hospital
City
Karaman
ZIP/Postal Code
70200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KERİMAN YILDIZ, MSc
Phone
+905333502357
Email
kerimanyildiz.ky70@gmail.com
First Name & Middle Initial & Last Name & Degree
SERPİL YÜKSEL, PhD
Phone
+905052933760
Email
syuksel@erbakan.edu.tr
First Name & Middle Initial & Last Name & Degree
SERPİL YÜKSEL, PhD
First Name & Middle Initial & Last Name & Degree
AHMET YILMAZ, PhD
First Name & Middle Initial & Last Name & Degree
KERİMAN YILDIZ, MSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
STUDY PROTOCOL
IPD Sharing Time Frame
After December 1, 2023
IPD Sharing Access Criteria
Anyone who wishes to access the data. Study Protocol.

Learn more about this trial

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

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