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临床试验/NCT06627725
NCT06627725已完成不适用

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

Yasemin Kalkan Uğurlu1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年5月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •Hearing and speech problems.

研究组 & 干预措施

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

干预措施: Patient-Family Communication (Behavioral)

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.

结局指标

主要结局

Visual Analog Scale

时间窗: 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.

The Hospital Anxiety Depression Scale

时间窗: 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.

Family Satisfaction in the İntensive Care Unit

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Yasemin Kalkan Uğurlu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yasemin Kalkan Uğurlu

Assit Prof.

T.C. ORDU ÜNİVERSİTESİ

研究点 (1)

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