Clinical trial NCT06260085: Effect of Listening to Relatives' Voice Recordings on Chest Pain, Anxiety, and Depression in Coronary ICU Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Intensive Care Unit Syndrome
Keywords: Acute myocardial infarction
Anxiety
Chest pain
Voice recording
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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".

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Chest Pain
timeFrame: 15 minutes before (T1), 15 minutes later (T2), 30 minutes later (T3)
Secondary outcomes:
measure: Anxiety, and Depression
timeFrame: 15 minutes before (T1), 15 minutes later (T2), 30 minutes later (T3)
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Yasemin Kalkan Uğurlu
Study officials:
References: