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Completed

NCT Number: NCT06723977

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

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.

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Key information

Conditions

Schizophrenia Behavior Behavioral Symptoms Caregiver Burden Expressed Emotion Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Stress, Psychological

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center

Diyarbakır, Yenişehir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auditory Hallucination Based Voice Hearing Simulation

Other
  • st stage: Preparation of the environment, introduction, providing information about the purpose, duration and content of the application, application of data collection tools and distribution of the information brochure were provided.
  • nd stage: Introducing the recording devices and headphones, performing the first task simultaneously while listening to the prepared three-dimensional sound recording (watching a city promotional film and answering verbal questions about this film), performing the second task simultaneously while listening to the prepared three-dimensional voice recording (telling a story). (reading the text and answering the questions about this story text in writing) were applied.
  • rd stage: Information about the next application time of the measurement tools was provided.

Additional stage: Data collection tools were reapplied.

Primary outcomes

  1. Level of Expressed Emotion Scale - LEES

    Time frame: 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.

  2. The Perceived Family Burden Scale - PFBS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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