Clinical trial NCT06723977: Effect of Simulation on Emotional Expression and Perceived Family Burden of Caregivers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Caregiver Burden
Expressed Emotion
Keywords: schizophrenia
perceived family burden
expressed emotion
psychiatric nursing
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted with 20 caregivers of individuals diagnosed with schizophrenia in the intervention group and 20 caregivers of individuals diagnosed with schizophrenia in the control group.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of Expressed Emotion Scale - LEES
timeFrame: one month
measure: The Perceived Family Burden Scale - PFBS
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center
state: Yenişehir
Study officials:
affiliation: Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center
name: Fatma Gül Sak, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: