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

NCT06723977 | Completed DMC

• 1 other identifier: ESOGÜ-SBE-FGS-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Caregiver Burden; Expressed Emotion

Keywords

schizophrenia; perceived family burden; expressed emotion; psychiatric nursing

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  one month

Study Arms (2)

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.

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.

Interventions

Auditory Hallucination Based Voice Hearing Simulation 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.

intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center

Diyarbakır, Yenişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia; Caregiver Burden

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Fatma Gül Sak, PhD Student

  Diyarbakır Selahaddin Eyyubi State Hospital Community Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD student

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: December 9, 2024
• Study Start: April 20, 2022
• Primary Completion: March 15, 2023
• Study Completion: July 4, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)