Effect of Simulation on Emotional Expression and Perceived Family Burden of Caregivers

Not Applicable

Completed

• Conditions: Schizophrenia; Caregiver Burden; Expressed Emotion

• Registration Number: NCT06723977
• Lead Sponsor: Eskisehir Osmangazi University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-04-20
• Primary Completion: 2023-03-15
• Study Completion: 2024-07-04
• Study First Submitted: 2024-07-16
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Level of Expressed Emotion Scale - LEES	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	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.

Trial Locations

Locations (1)

Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center; 🇹🇷 Diyarbakır, Yenişehir, Turkey