The Effect of Patient-Family Communication Via Audio Recording
1 other identifier
interventional
55
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2023
CompletedFirst Submitted
Initial submission to the registry
September 28, 2024
CompletedFirst Posted
Study publicly available on registry
October 4, 2024
CompletedOctober 4, 2024
October 1, 2024
1.1 years
September 28, 2024
October 3, 2024
Conditions
Keywords
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
EXPERIMENTALThe 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
Control
NO INTERVENTIONAfter 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
Eligibility Criteria
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- 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