SchizophreniaNCT06723977
Effect of Simulation on Emotional Expression and Perceived Family Burden of Caregivers
A study testing Auditory Hallucination Based Voice Hearing Simulation in people with Schizophrenia and Caregiver Burden, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Caregiver Burden, Expressed Emotion
- What is being tested?
- Auditory Hallucination Based Voice Hearing Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2022to 4 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center
Diyarbakır, Yenişehir
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia, Caregiver Burden, Expressed Emotion
- Being tested
- Auditory Hallucination Based Voice Hearing Simulation
- Keywords
- schizophrenia, perceived family burden, expressed emotion, psychiatric nursing
- Medical subject headings
- Schizophrenia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory Hallucination Based Voice Hearing SimulationOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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. Receives: Other: Auditory Hallucination Based Voice Hearing Simulation |
| control group | No intervention | The control group continued the routine practices of the clinic and was given an information brochure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Expressed Emotion Scale - LEES
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.
Measured: one month
The Perceived Family Burden Scale - PFBS
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start20 Apr 2022
- Primary completion15 Mar 2023
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Gül SAK, Eskisehir Osmangazi University
- Investigators
- Fatma Gül Sak, PhD Student, Principal investigator, Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723977
- Sponsor's protocol ID
- ESOGÜ-SBE-FGS-01
- Status last verified
- Dec 2024
- First submitted
- 16 Jul 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A utility model application will be made for the application. Therefore, the data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06723977
- Acronym / sponsor ID
- ESOGÜ-SBE-FGS-01
- Conditions
- Schizophrenia, Caregiver Burden, Expressed Emotion
- Keywords
- schizophrenia, perceived family burden, expressed emotion, psychiatric nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Auditory Hallucination Based Voice Hearing SimulationAuditory 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. |
| control group | No intervention | –The control group continued the routine practices of the clinic and was given an information brochure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory Hallucination Based Voice Hearing Simulation1. 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. | Other | intervention group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No. A utility model application will be made for the application. Therefore, the data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Gül Sak, PhD Student principal investigator
Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Hallucination Based Voice Hearing Simulation in people with Schizophrenia and Caregiver Burden, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Expressed Emotion Scale - LEES (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.