EFFECT OF FACE-TO-FACE AND VIRTUAL REALITY-BASED SALUTOGENESIS NURSING CARE IN PATIENTS WITH DEMENTIA (SM-VR-DEMENTIA)
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MERVE E KILIÇASLAN, Registered Nurse
- Phone Number: +90 555 176 15 93
- Email: merveekinaka@outlook.com
Study Locations
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Bor
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Niğde, Bor, Turkey (Türkiye)
- Recruiting
- Niğde/Bor
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Contact:
- Duran Ü, 1
- Phone Number: +905541385351
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sense of Coherence
Time Frame: Baseline, after 8 weeks (post-intervention), and 3 months after the intervention
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Sense of coherence will be assessed using the Sense of Coherence Scale (SOC-13), which evaluates the components of meaningfulness, comprehensibility, and manageability.
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Baseline, after 8 weeks (post-intervention), and 3 months after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life (WHOQOL-BREF)
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: HANDAN ZİNCİR, PhD, Erciyes University, Faculty of Health Sciences, Department of Public Health Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SM-DEMENTİA-VR-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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