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Clinical Trials/NCT05514574
NCT05514574
Completed
Not Applicable

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

Keriman Yildiz1 site in 1 country183 target enrollmentAugust 2, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Percutaneous Coronary Intervention
Sponsor
Keriman Yildiz
Enrollment
183
Locations
1
Primary Endpoint
State Anxiety Score
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2, 2022
End Date
October 27, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Keriman Yildiz
Responsible Party
Sponsor Investigator
Principal Investigator

Keriman Yildiz

Study Director

Necmettin Erbakan University

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,

Outcomes

Primary Outcomes

State Anxiety Score

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.

Change in State Anxiety Score after intervention.

Secondary Outcomes

  • 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)
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • 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.)

Study Sites (1)

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