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Completed

NCT Number: NCT05514574

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Karaman, 70200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Music

Other

"hussoni duseni " music

Stress ball

Other

Stress ball squeeze

Primary outcomes

  1. 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

  1. Systolic Blood Pressure Value (mmHg)

    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

    Change in Systolic Blood Pressure Value after intervention.

  2. Diastolic Blood Pressure Value (mmHg)

    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.

    Change in Diastolic Blood Pressure Value after intervention.

  3. Mean Arterial Pressure Value (mmHg)

    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.

    Change in Mean Arterial Pressure Value after intervention.

  4. Heart Rate/Minute Value

    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.

    Change in Heart Rate/Minute Value after intervention.

  5. Respiratory Rate/Minute Value

    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.

    Change in Respiratory Rate/Minute Value after intervention.

  6. Peripheral Oxygen Saturation (SpO2) Value

    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.

    Change in Peripheral Oxygen Saturation Value after intervention.

Sponsors and collaborators

Lead sponsor

Keriman Yildiz

Other

Collaborators

  • Necmettin Erbakan University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2022
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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