The Effect of Listening to Music and Stress Ball Application on Patients' Anxiety Level and Hemodynamic Parameters During Percutaneous Coronary Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 183
- Locations
- 1
- Primary Endpoint
- State Anxiety Score
Study 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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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,
Arms & Interventions
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.
Intervention: Music (Other)
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.
Intervention: Stress ball (Other)
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.
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.)
Investigators
Keriman Yildiz
Study Director
Necmettin Erbakan University