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

December 6, 2024 updated by: Fatma Gül SAK, Eskisehir Osmangazi University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yenişehir
      • Diyarbakır, Yenişehir, Turkey
        • Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
Auditory Hallucination Based Voice Hearing Simulation application was applied to the intervention group and an information brochure was given. Auditory Hallucination Based Voice Hearing Simulation was applied only once to caregivers of individuals diagnosed with schizophrenia. The application took an average of 45 minutes.
Other: Auditory Hallucination Based Voice Hearing Simulation
  1. 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.
  2. 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.
  3. rd stage: Information about the next application time of the measurement tools was provided.

Additional stage: Data collection tools were reapplied.
No Intervention: control group
The control group continued the routine practices of the clinic and was given an information brochure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one month
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.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Investigators

  • Principal Investigator: Fatma Gül Sak, PhD Student, Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2022

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

July 4, 2024

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESOGÜ-SBE-FGS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A utility model application will be made for the application. Therefore, the data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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