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临床试验/NCT06723977
NCT06723977已完成不适用

The Effect of Auditory Hallucination-based Sound Simulation Application That is Listened to by Caregivers of Individuals with Schizophrenia on Their Emotional Expression and Perceived Family Burden

Eskisehir Osmangazi University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Level of Expressed Emotion Scale - LEES

研究概览

简要总结

The aim of this study is to determine the effect of Auditory Hallucination Based Voice Hearing Simulation on the emotional expression and perceived family burden of caregivers of individuals diagnosed with schizophrenia.

详细描述

Objective

The aim of this study is to determine the effect of Auditory Hallucination Based Voice Hearing Simulation on the emotional expression and perceived family burden of caregivers of individuals diagnosed with schizophrenia.

Method: This study was designed in a pre-test - post-test, randomized controlled design. The study was conducted with 20 caregivers in the intervention group and 20 caregivers of individuals diagnosed with schizophrenia in the control group. Data were collected between March 2023 and October 2023 using the Emotional Expression Scale and Perceived Family Burden Scale. Auditory Hallucination Based Voice Hearing Simulation was applied to the intervention group. This sound recording is three-dimensional. While the audio recording is played to the caregivers; Users were asked to complete two tasks, each lasting 10 minutes. The tasks were carried out under the guidance prepared by the researchers. In the control group, the routine practices of the clinic continued.

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
None

盲法说明

While written consent was obtained from the individuals included in the study, a different form was used for each group. For this reason, participants could not be blinded. In addition, since the data collection and application process had to be actively managed, researcher blinding was not possible. The randomization table was prepared by an independent statistician to avoid the possibility of bias.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having been living with an individual diagnosed with schizophrenia for at least one year.
  • Being primarily responsible for the care of the individual diagnosed with schizophrenia,
  • Being between the ages of 18-65,
  • Being literate,
  • Speaking Turkish,
  • Volunteering to participate in the study.

排除标准

  • Having a physical disability to perform the assigned tasks,
  • Having any health problem related to hearing ability,
  • Having any mental illness,
  • Having received 2 or more points from the General Health Questionnaire-12.

结局指标

主要结局

Level of Expressed Emotion Scale - LEES

时间窗: one month

The scale was developed to measure the quality of social interaction between the patient and the caregiver. The scale consists of 41 items. The maximum total score obtained from the scale is 41, and the minimum is 0. High scores from the scale indicate that the caregiver has high emotional expression.

The Perceived Family Burden Scale - PFBS

时间窗: one month

This scale, which is applied to relatives of individuals diagnosed with schizophrenia, was developed to evaluate the family burden perceived by the patient's relatives. The scale, which evaluates the patient's relative's perception of family burden in the last month, consists of 24 items and two parts, A-B. The maximum total score obtained from the scale is 108, and the minimum is 0. The scale does not have a cut-off point, and high scores from the scale indicate a high perceived family burden.

次要结局

未报告次要终点

研究者

发起方
Eskisehir Osmangazi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Gül SAK

Principal Investigator, PhD student

Eskisehir Osmangazi University

研究点 (1)

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