Acute Myocardial InfarctionNCT06260085
Effect of Listening to Relatives' Voice Recordings on Chest Pain, Anxiety, and Depression in Coronary ICU Patients
A study testing Relatives vioce record in people with Acute Myocardial Infarction and Intensive Care Unit Syndrome, run by Ordu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction, Intensive Care Unit Syndrome
- What is being tested?
- Relatives vioce record
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jun 2022to 4 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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".
Read the 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.
- Being tested
- Relatives vioce record
- Keywords
- Acute myocardial infarction, Anxiety, Chest pain, Voice recording
- Medical subject headings
- Anxiety Disorders, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relatives vioce recordOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Relatives vioce record |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 minutes before (T1), 15 minutes later (T2), 30 minutes later (T3)
Secondary outcomes (1)
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.
Measured: 15 minutes before (T1), 15 minutes later (T2), 30 minutes later (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start4 Jun 2022
- Primary completion4 Jul 2023
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Kalkan Uğurlu, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260085
- Sponsor's protocol ID
- 686
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06260085
- Acronym / sponsor ID
- 686
- Keywords
- Acute myocardial infarction, Anxiety, Chest pain, Voice recording
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 4 Jun 2022 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Relatives vioce recordIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relatives vioce recordIn 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. | Other | İntervention |
Primary outcome
Chest Pain
Time frame: 15 minutes before (T1), 15 minutes later (T2), 30 minutes later (T3)
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
1 secondary outcome
Anxiety, and Depression
Time frame: 15 minutes before (T1), 15 minutes later (T2), 30 minutes later (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relatives vioce record in people with Acute Myocardial Infarction and Intensive Care Unit Syndrome, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest Pain (time frame: 15 minutes before (T1), 15 minutes later (T2), 30 minutes later (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.