MedDataX Logo

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

NCT ID: NCT06723977

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-20

Study Completion Date

2024-07-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Caregiver Burden Expressed Emotion

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

schizophrenia perceived family burden expressed emotion psychiatric nursing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Auditory Hallucination Based Voice Hearing Simulation

Intervention Type OTHER

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.

control group

The control group continued the routine practices of the clinic and was given an information brochure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fatma Gül SAK

Principal Investigator, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fatma Gül Sak, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center

Diyarbakır, Yenişehir, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ESOGÜ-SBE-FGS-01

Identifier Type: -

Identifier Source: org_study_id