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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05514574
Enrollment
183
Registered
2022-08-24
Start date
2022-08-02
Completion date
2023-10-27
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Hemodynamics, Percutaneous Coronary Intervention

Keywords

percutaneous coronary intervention, anxiety, hemodynamics, music, stress ball

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.

Interventions

OTHERMusic

hussoni duseni music

OTHERStress ball

Stress ball squeeze

Sponsors

Necmettin Erbakan University
CollaboratorOTHER
Keriman Yildiz
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Patients and their relatives, clinical staff, will be blinded to the 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.

Intervention model description

Parallel Assignment Prospective Non-Randomized Controlled Clinical Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
State Anxiety ScoreEach 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

MeasureTime frameDescription
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.
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 formChange in Systolic Blood Pressure Value after intervention.
Respiratory Rate/Minute ValueRespiratory 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) ValuePeripheral 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.
Heart Rate/Minute ValueHeart 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026