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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

55

Phase

  • 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

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
Intervention / Treatment
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

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

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)

May 10, 2022

Primary Completion (Actual)

June 10, 2023

Study Completion (Actual)

June 10, 2023

Study Registration Dates

First Submitted

September 28, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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