The Effect of Patient-Family Communication Via Audio Recording

October 3, 2024 updated by: Yasemin Kalkan Uğurlu

The Effect of Patient-Family Communication Via Audio Recording on Anxiety, Depression, and Satisfaction of Cardiovascular Intensive Care Unit (CICU) Patients&Amp;Amp;Amp;#39; Relatives: Randomized Controlled Trial

The study was conducted as a randomized controlled blinded study. The sample consisted of 55 patient relatives (27 in the experimental group and 28 in the control group). The patient's relatives in the experimental group said what they wanted to say to their patient in line with the content determined by the researchers and recorded it using a voice recorder. The researcher played the recorded message to the patient, and the patient's feedback was conveyed to the patient's relative.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Visitor restrictions in coronary intensive care units (CICUs), which make it difficult for relatives to communicate with and support their patients, can lead to negative emotional reactions such as anxiety, depression and anger in family members. This study was conducted to determine the effect of playing the voice recording of the relatives to the patients hospitalized in CICU on the anxiety, depression and satisfaction levels of the relativesThe study was conducted as a randomized controlled single blinded study. The sample consisted of 55 patient relatives (27 in the experimental group and 28 in the control group). The patient's relative in the experimental group said what they wanted to say to their patient in line with the content determined by the researchers and recorded it using a voice recorder. The recorded message was played to the patient by the researcher and the feedback of the patient was conveyed to the patient's relative by the researcher. The relatives of the patients in the control group were routinely informed. The "Patient Relative Introduction Form", "Hospital Anxiety Depression Scale (HADS)", "Visual Analog Scale-Anxiety (VAS-A)" and "Satisfaction Scale of Families of Patients Hospitalized in Intensive Care Unit (FS-ICU)" were used to collect the data.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ordu, Turkey, 52200
        • Ordu university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being able to speak and understand Turkish,
  • Being a first-degree relative of a patient hospitalized in the CICU with AMI.

Exclusion Criteria:

  • Hearing and speech problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: intervention
The voice message prepared by a patient's relative, decided by the patient's family members, was recorded using a voice recorder. Before the voice message was recorded, the researcher met with the patient's relative and gave preliminary information about the message content (Table 1) in order to prevent the message from negatively affecting the patient. In the study, care was taken to ensure that the messages to be played to the patient were between 3-5 minutes and simple terms that could be understood by individuals with low educational level were used. The patient's relatives recorded the messages they wanted to convey to the patient with a voice recorder. The voice message was played to the patient by the researcher using a music pillow in the CICU . After the condition of the patient in the intervention group stabilized, a pretest (IIF, HADS, VAS-A, FS-ICU) was administered to the patient's relative, then a voice recording was prepared and the patient's relative's voice recording
Behavioral: Patient-Family Communication
Patient-Family Communication
No Intervention: Control
After the condition of the patients in the control group stabilized, a pretest (IIF, HADS, VAS-A, FS-ICU) was administered to the relatives. Afterwards, the relatives were routinely informed about the patient's general condition, treatment process, and needs.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Hospital Anxiety Depression Scale
Time Frame: 10 minutes
The scale consists of 14 items, seven items measure anxiety (HAD-A) and the other seven items measure depression (HAD-D). The scale is a four-point Likert-type scale with a total scoe of 0-42.
10 minutes
Visual Analog Scale
Time Frame: 2 minutes
The VAS-A consists of a 10 cm horizontal line ranging from 0 to 10, with zero representing the lowest level of anxiety and 10 representing the highest level.
2 minutes
Family Satisfaction in the İntensive Care Unit
Time Frame: 5 minutes
The scale consists of 24 five-point Likert-type questions and consists of three sub-dimensions: care, decision-making and knowledge. For each statement, respondents mark the most appropriate answer between 1 and 5, ranging from 5 (Excellent) to 1 (Poor). The higher the scores obtained from the scale, the higher the level of satisfaction.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yasemin Kalkan Uğurlu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1988

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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