Acute Myocardial Infarction Clinical Trial
Official title:
The Effect of Listening to the Voice Recording of Relatives on Chest Pain, Anxiety and Depression in Patients Hospitalised in Coronary Intensive Care Unit: Randomised Controlled Study
NCT number | NCT06260085 |
Other study ID # | 686 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 4, 2022 |
Est. completion date | September 4, 2023 |
Verified date | February 2024 |
Source | T.C. ORDU ÜNIVERSITESI |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study was to evaluate the effect of listening to the voice recordings of relatives of patients with acute myocardial infarction (AMI) who were treated in the coronary intensive care unit on chest pain, anxiety and depression parameters of the patients. Methods In the study, which was conducted as a randomised, controlled, experimental study, voice recordings of the family members of the patients were created and played to the patients through a music pillow. The study was carried out with 60 patients, 30 experimental and 30 control groups. Three tests were applied to the patients 15 minutes before, 15 and 30 minutes after the application. The data of the study were collected using the "Patient Introduction Form", "Hospital Anxiety Depression Scale", "Visual Analogue Scale" and "Patient Follow-up Form".
Status | Completed |
Enrollment | 60 |
Est. completion date | September 4, 2023 |
Est. primary completion date | July 4, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult age group (over 18 years), - Not being diagnosed with psychiatric and neurological diseases, - Diagnosis of AMI by a cardiologist, - First time in the coronary intensive care unit, - It's his first AMI, - Being able to speak and understand Turkish. Exclusion Criteria: - Known hearing problems, - Previous cardiovascular disease and history of myocardial infarction, - Previous coronary artery bypass surgery and/or percutaneous transluminal coronary angioplasty to be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Yasemin Kalkan Ugurlu | Ordu |
Lead Sponsor | Collaborator |
---|---|
T.C. ORDU ÜNIVERSITESI |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chest Pain | Patients' chest pain was assessed using a visual analog scale (VAS). The VAS consists of a 10 cm horizontal line ranging from 0 to 10, with zero indicating the lowest level of pain and 10 indicating the highest level. Patients were asked to describe the intensity of chest pain on a scale of 0-10. The VAS criterion is very effective, valid and reliable in determining the intensity of pain. The VAS is also a standardized scale for measuring anxiety with appropriate validity and reliability that has been used in various studies | 15 minutes before (T1), 15 minutes later (T2), 30 minutes later (T3) | |
Secondary | Anxiety, and Depression | Patients' anxiety and depression was assessed using The Hospital Anxiety Depression (HAD) Scale was developed by Zigmond and Snaith (1983) to determine the patient's risk for anxiety and depression and to measure the level and severity change .As a result of the validity and reliability study, the cut-off score for the anxiety subscale (HAD-A) was 10 and the cut-off score for the depression subscale (HAD-D) was 7. Accordingly, those who score above these points are considered to be at risk. The scale is a four-point Likert-type scale and the total scale score is scored between 0-42. | 15 minutes before (T1), 15 minutes later (T2), 30 minutes later (T3) |
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