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| Name | Class |
|---|---|
| Necmettin Erbakan University | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music | Experimental | 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. |
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| Stress ball | Experimental | 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. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music | Other | "hussoni duseni " music |
| |
| Stress ball |
| Measure | Description | Time Frame |
|---|---|---|
| State Anxiety Score | Change in State Anxiety Score after intervention. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure Value (mmHg) | Change in Systolic Blood Pressure Value after intervention. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Criteria for exclusion from follow-up:
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| Name | Affiliation | Role |
|---|---|---|
| SERPÄ°L YÃœKSEL, PhD | Necmettin Erbakan University | Principal Investigator |
| AHMET YILMAZ, PhD | KaramanoÄŸlu Mehmetbey University | Study Director |
| KERÄ°MAN YILDIZ, MSc | Necmettin Erbakan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karaman Provincial Health Directorate Karamanoğlu Mehmetbey University Karaman Training and Research Hospital | Karaman | 70200 | Turkey (Türkiye) |
STUDY PROTOCOL
After December 1, 2024
Anyone who wishes to access the data. Study Protocol.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Parallel Assignment Prospective Non-Randomized Controlled Clinical Trial
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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.
| Other |
Stress ball squeeze |
|
| Diastolic Blood Pressure Value (mmHg) | Change in Diastolic Blood Pressure Value after intervention. | 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. |
| Mean Arterial Pressure Value (mmHg) | Change in Mean Arterial Pressure Value after intervention. | 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. |
| Heart Rate/Minute Value | Change in Heart Rate/Minute Value after intervention. | 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 | Change in Respiratory Rate/Minute Value after intervention. | 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 | Change in Peripheral Oxygen Saturation Value after intervention. | 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. |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |