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

NCT06260085 | Completed

• 1 other identifier: 686
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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".

Conditions

Acute Myocardial Infarction; Intensive Care Unit Syndrome

Keywords

Acute myocardial infarction; Anxiety; Chest pain; Voice recording

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anxiety, and Depression

  15 minutes before (T1), 15 minutes later (T2), 30 minutes later (T3)

Study Arms (2)

Control

NO INTERVENTION

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.

İntervention

EXPERIMENTAL

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.

Other: Relatives vioce record

Interventions

Relatives vioce record OTHER

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.

İntervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Yasemin Kalkan Uğurlu

Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Chest Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical nurse collected the data
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof.

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 15, 2024
• Study Start: June 4, 2022
• Primary Completion: July 4, 2023
• Study Completion: September 4, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)