Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

EFFECT OF FACE-TO-FACE AND VIRTUAL REALITY-BASED SALUTOGENESIS NURSING CARE IN PATIENTS WITH DEMENTIA (SM-VR-DEMENTIA)

8 de septiembre de 2026 actualizado por: MERVE EKİN KILIÇASLAN, TC Erciyes University

THE EFFECT OF SALUTOGENESIS MODEL-BASED NURSING CARE DELIVERED FACE-TO-FACE AND VIA VIRTUAL REALITY ON SENSE OF COHERENCE AND QUALITY OF LIFE IN PATIENTS WITH DEMENTIA

The purpose of this clinical study is to examine the effects of nursing care based on the Salutogenesis Model on the sense of coherence (meaningfulness, comprehensibility, and manageability) and quality of life of people living with dementia. The study will also evaluate whether delivering this nursing care face-to-face or through virtual reality leads to similar or different benefits, and whether these benefits are maintained over time.

The main questions this study aims to answer are:

Does face-to-face nursing care based on the Salutogenesis Model help people living with dementia strengthen their sense of coherence, cope better with daily life, and improve their quality of life? Does delivering the same nursing care using virtual reality lead to similar or different effects on sense of coherence and quality of life compared to face-to-face care? Do the positive effects of this nursing care continue after the intervention has ended? Researchers will compare three groups to answer these questions: a group receiving face-to-face nursing care based on the Salutogenesis Model, a group receiving the same nursing care using virtual reality, and a control group receiving usual care.

Participants will take part in the study over a period of several months. During the study, participants will be asked to:

Take part in nursing care sessions once a week for eight weeks Complete questionnaires that assess sense of coherence and quality of life Complete these questionnaires at the start of the study, after the eight-week nursing care program is completed (mid-term follow-up), and approximately three months after the interventions have ended (final follow-up) These assessments aim to evaluate both the short-term effects of the nursing care and whether these effects are sustained over the longer term.

The results of this study are expected to contribute to the development of more supportive and innovative nursing care approaches for people living with dementia and to provide evidence on the use of virtual reality as a supportive tool in nursing care.

Descripción general del estudio

Descripción detallada

DETAILED DESCRIPTION

This study is a randomized controlled experimental trial designed to evaluate the effects of nursing care based on the Salutogenesis Model on sense of coherence and quality of life in individuals living with mild to moderate dementia. The study compares the effectiveness of the same nursing care delivered through two different methods-face-to-face and via virtual reality (VR) headsets-against usual care.

The Salutogenesis Model focuses on individuals' capacity to understand their life situations, manage daily challenges, and find meaning in their experiences. The central concept of the model is sense of coherence, which consists of three components: comprehensibility, manageability, and meaningfulness. This study applies the Salutogenesis Model as a holistic nursing framework to support people living with dementia by strengthening these components despite cognitive decline.

Study Design and Setting The study will be conducted in Niğde Bor district, Türkiye, and coordinated through Bor State Hospital. All assessments and interventions will be carried out in participants' home environments to increase comfort, reduce barriers to participation, and reflect real-life conditions.

Participants with mild to moderate dementia will be randomly assigned to one of three groups:

Intervention Group 1 (MG1): Receives face-to-face nursing care based on the Salutogenesis Model Intervention Group 2 (MG2): Receives the same nursing care supported by virtual reality headsets Control Group: Receives usual care without additional structured nursing intervention Randomization will be performed using a computer-based simple randomization method by an independent researcher to minimize allocation bias.

Intervention Procedures Both intervention groups will receive an eight-week nursing care program based on the Salutogenesis Model. Sessions will be conducted once per week and will last approximately 40-60 minutes.

The content of the nursing care program is identical for both intervention groups and is structured to support:

Meaningfulness: through life review, reminiscence activities, meaningful memories, music, and personalized activities Comprehensibility: through structured routines, clear explanations, environmental organization, and supportive communication Manageability: through problem-solving strategies, daily activity planning, medication routines, and strengthening personal and social resources

In the VR-supported group, selected components of the intervention (such as reminiscence activities, meaningful environments, music, and visual stimuli) will be delivered using VR headsets, allowing participants to experience these elements in an immersive digital environment. The face-to-face group will receive the same content using traditional, in-person methods without VR.

Data Collection and Follow-Up

Outcome measures will be collected at three time points:

Baseline assessment (before intervention) Post-intervention assessment (after the eight-week nursing care program) Follow-up assessment approximately three months after the intervention ends These follow-up assessments are designed to evaluate both short-term effects and the sustainability of the intervention outcomes over time.

Primary outcomes include changes in sense of coherence (comprehensibility, manageability, and meaningfulness) and quality of life. Data will be collected using validated assessment tools administered through face-to-face interviews.

Significance By comparing face-to-face and VR-supported delivery of Salutogenesis Model-based nursing care, this study aims to provide evidence on whether digital health technologies such as virtual reality can be used as effective and supportive tools in dementia nursing care. The findings are expected to contribute to the development of holistic, innovative, and sustainable nursing interventions that enhance quality of life and sense of coherence in people living with dementia.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

73

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: MERVE E KILIÇASLAN, Registered Nurse
  • Número de teléfono: +90 555 176 15 93
  • Correo electrónico: merveekinaka@outlook.com

Ubicaciones de estudio

    • Bor
      • Niğde, Bor, Turquía (Türkiye)
        • Reclutamiento
        • Niğde/Bor
        • Contacto:
          • Duran Ü, 1
          • Número de teléfono: +905541385351

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • -Individuals aged 18 years and older.
  • Individuals who are able to read and write.
  • Individuals with a Standardized Mini-Mental Test (SMMT) score between 11 and 23, indicating mild to moderate dementia.
  • Individuals without severe speech or language impairments that would limit communication.
  • Individuals with non-progressive or clinically stable dementia, defined as cognitive symptoms that do not show marked deterioration over time.
  • Individuals who have provided written informed consent, or whose legal representative has provided written informed consent.
  • Individuals who are able to participate in the intervention sessions using virtual reality headsets independently or with the support of a caregiver.

Exclusion Criteria:

  • Inability to complete assessments due to severe psychotic symptoms (e.g., hallucinations, paranoid thoughts) or uncontrolled behavioral symptoms such as aggression or severe agitation.
  • Presence of progressive neurological diseases that impair motor and cognitive functions, such as Parkinson's disease or Huntington's disease.
  • A Standardized Mini-Mental Test (SMMT) score below 10.
  • Being older than 80 years of age.
  • Absence of a caregiver.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Face-to-Face Salutogenesis Model-Based Nursing Care
Participants in this arm will receive face-to-face nursing care based on the Salutogenesis Model. The intervention will be delivered once a week for eight weeks, with each session lasting approximately 40-60 minutes. The nursing care will be structured to strengthen sense of coherence (meaningfulness, comprehensibility, and manageability) and to improve quality of life.
Nursing care based on the Salutogenesis Model delivered face-to-face once a week for eight weeks, with each session lasting approximately 40-60 minutes. The intervention focuses on strengthening sense of coherence by supporting meaningfulness, comprehensibility, and manageability, and aims to improve participants' quality of life through structured, person-centered nursing care.
Experimental: Virtual Reality-Supported Salutogenesis Model-Based Nursing Care
Participants in this arm will receive Salutogenesis Model-based nursing care supported by virtual reality headsets. The content of the intervention will be the same as the face-to-face nursing care and will be delivered once a week for eight weeks, with each session lasting approximately 40-60 minutes. The nursing care will aim to strengthen sense of coherence and improve quality of life, while virtual reality will be used as a supportive tool for delivering selected components of the intervention.
Nursing care based on the Salutogenesis Model will be delivered using virtual reality headsets. The intervention will be provided once a week for eight weeks, with each session lasting approximately 40-60 minutes. The content of the intervention will be the same as that used in the face-to-face nursing care and will aim to strengthen sense of coherence and improve quality of life. Virtual reality headsets will be used as a supportive tool to deliver selected components of the nursing care in an immersive digital environment.
Sin intervención: Usual Care (Control Group)
Participants in this arm will continue to receive usual care during the study period and will not receive any additional structured nursing intervention related to the study.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sense of Coherence
Periodo de tiempo: Baseline, after 8 weeks (post-intervention), and 3 months after the intervention
Sense of coherence will be assessed using the Sense of Coherence Scale (SOC-13), which evaluates the components of meaningfulness, comprehensibility, and manageability.
Baseline, after 8 weeks (post-intervention), and 3 months after the intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quality of Life (WHOQOL-BREF)
Periodo de tiempo: Baseline, after 8 weeks (post-intervention), and 3 months after the intervention
Quality of life will be assessed using the World Health Organization Quality of Life Scale (WHOQOL-BREF).
Baseline, after 8 weeks (post-intervention), and 3 months after the intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: HANDAN ZİNCİR, PhD, Erciyes University, Faculty of Health Sciences, Department of Public Health Nursing

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de mayo de 2026

Finalización primaria (Estimado)

15 de septiembre de 2026

Finalización del estudio (Estimado)

15 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

8 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de septiembre de 2026

Publicado por primera vez (Actual)

14 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • SM-DEMENTİA-VR-2025

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared due to ethical considerations, the sensitive nature of the study population, and privacy concerns.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir