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CompletedNCT06627725Updated Oct 4, 2024

The Effect of Patient-Family Communication Via Audio Recording

An interventional study of Patient-Family Communication in Anxiety, Anxiety Depression (Mild or Not Persistent) and Satisfaction With Care, sponsored by Yasemin Kalkan Uğurlu. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-04.

Sponsored by Yasemin Kalkan Uğurlu · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled May 2022, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Anxiety
  • Anxiety Depression (Mild or Not Persistent)
  • Satisfaction With Care

Keywords

  • Anxiety
  • Family
  • Depression
  • Satisfaction
  • intensive care unit
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 55 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Yasemin Kalkan Uğurlu is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Hearing and speech problems.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
55 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralPatient-Family Communication

    Patient-Family Communication

06

What researchers measure

Primary outcomes

  1. The Hospital Anxiety Depression Scale

    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.

    Time frame: 10 minutes

  2. Visual Analog Scale

    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.

    Time frame: 2 minutes

  3. Family Satisfaction in the İntensive Care Unit

    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.

    Time frame: 5 minutes

07

Study locations

1 site
  • Ordu University
    Ordu, 52200, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06627725
Lead sponsor
Yasemin Kalkan Uğurlu
Responsible party
Yasemin Kalkan Uğurlu (Assit Prof., T.C. ORDU ÜNİVERSİTESİ) — Sponsor-investigator
First posted
Oct 4, 2024
Start date
May 10, 2022
Primary completion
Jun 10, 2023
Completion
Jun 10, 2023
Last update
Oct 4, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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