NCT06627725

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

September 28, 2024

Last Update Submit

October 3, 2024

Conditions

Keywords

AnxietyFamilyDepressionSatisfactionintensive care unit

Outcome Measures

Primary Outcomes (3)

  • 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.

    10 minutes

  • 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.

    2 minutes

  • 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.

    5 minutes

Study Arms (2)

intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Patient-Family Communication

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hearing and speech problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersLymphoma, FollicularDepressionPersonal Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Interventional Study Model.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assit Prof.

Study Record Dates

First Submitted

September 28, 2024

First Posted

October 4, 2024

Study Start

May 10, 2022

Primary Completion

June 10, 2023

Study Completion

June 10, 2023

Last Updated

October 4, 2024

Record last verified: 2024-10

Locations