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

8 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

73

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Bor
      • Niğde, Bor, Turchia (Türkiye)
        • Reclutamento
        • Niğde/Bor
        • Contatto:
          • Duran Ü, 1
          • Numero di telefono: +905541385351

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sense of Coherence
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Life (WHOQOL-BREF)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: HANDAN ZİNCİR, PhD, Erciyes University, Faculty of Health Sciences, Department of Public Health Nursing

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 maggio 2026

Completamento primario (Stimato)

15 settembre 2026

Completamento dello studio (Stimato)

15 settembre 2026

Date di iscrizione allo studio

Primo inviato

8 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 settembre 2026

Primo Inserito (Effettivo)

14 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • SM-DEMENTİA-VR-2025

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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