Effect of Listening to Relatives' Voice Recordings on Chest Pain, Anxiety, and Depression in Coronary ICU Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06260085
• Other study ID #: 686
• Status: Completed
• Phase: N/A
• Start date: June 4, 2022
• Est. completion date: September 4, 2023

Study information

• Verified date: February 2024
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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".

Description:

In the study, it was emphasized that the messages to be played to the patient should be 3-5 minutes and simple terms should be used in a way that can be understood by individuals with low education level. Written informed consent was obtained from the patient and the patient's relatives before the application. In the message recorded by a patient's relative decided by the patient's family members, the patient's relative said what he/she wanted to say to the patient and recorded it using a voice recorder. The researcher had a preliminary interview with the patient's relative before the voice recording was taken about the use of the voice recorder and the content of the message in order to prevent the messages from negatively affecting the patient. The voice recording created by the patient's relative was played to the patient by the researcher using a music pillow. After the patient listened to the audio recording, it was erased under the witness of the patient's relative.In this randomised, controlled, experimental study, patients were randomised into intervention and control groups according to gender and age groups. In the preliminary interviews with the family members of the patients in the intervention group, the message content was discussed with the relatives of the patients before the voice recording was taken and carefully prepared to prevent negative effects. After the patient's condition was stable, the pretest was administered 15 minutes before (T1) the voice recording of the patient's relative was played through the music pillow.After the application, two more tests were applied at 15 (T2) and 30 (T3) minutes. After the condition of the patients in the control group was stable, the pre-test was administered, then the patient was given routine information (Your mother/father/daughter/son/... is at the door, is there anything you want to tell them? I can convey and give feedback.). After the information, two more tests were administered at 15 and 30 minutes.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Chest Pain
• Infarction
• Intensive Care Unit Syndrome
• Myocardial Infarction

Intervention

Other:
• Relatives vioce record
In the study, it was emphasized that the messages to be played to the patient should be 3-5 minutes and simple terms should be used in a way that can be understood by individuals with low education level. Written informed consent was obtained from the patient and the patient's relatives before the application. In the message recorded by a patient's relative decided by the patient's family members, the patient's relative said what he/she wanted to say to the patient and recorded it using a voice recorder. The researcher had a preliminary interview with the patient's relative before the voice recording was taken about the use of the voice recorder and the content of the message (Table 1) in order to prevent the messages from negatively affecting the patient. The voice recording created by the patient's relative was played to the patient by the researcher using a music pillow. After the patient listened to the audio recording, it was erased under the witness of the patient's relative.

Locations

Country	Name	City	State
Turkey	Yasemin Kalkan Ugurlu	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

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)