DementiaSM-VR-DEMENTIANCT07816731
EFFECT OF FACE-TO-FACE AND VIRTUAL REALITY-BASED SALUTOGENESIS NURSING CARE IN PATIENTS WITH DEMENTIA
A study testing Face-to-Face Salutogenesis Model-Based Nursing Care and Virtual Reality-Supported Salutogenesis Model-Based Nursing Care in people with Dementia, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dementia
- What is being tested?
- Face-to-Face Salutogenesis Model-Based Nursing Care and Virtual Reality-Supported Salutogenesis Model-Based Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Face-to-Face Salutogenesis Model-Based Nursing Care, Virtual Reality-Supported Salutogenesis Model-Based Nursing Care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-Face Salutogenesis Model-Based Nursing CareBehavioural
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.
Virtual Reality-Supported Salutogenesis Model-Based Nursing CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face Salutogenesis Model-Based Nursing Care | Experimental | 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. Receives: Behavioral: Face-to-Face Salutogenesis Model-Based Nursing Care |
| Virtual Reality-Supported Salutogenesis Model-Based Nursing Care | Experimental | 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. Receives: Behavioral: Virtual Reality-Supported Salutogenesis Model-Based Nursing Care |
| Usual Care (Control Group) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Sense of Coherence
Sense of coherence will be assessed using the Sense of Coherence Scale (SOC-13), which evaluates the components of meaningfulness, comprehensibility, and manageability.
Measured: Baseline, after 8 weeks (post-intervention), and 3 months after the intervention
Secondary outcomes (1)
Quality of Life (WHOQOL-BREF)
Quality of life will be assessed using the World Health Organization Quality of Life Scale (WHOQOL-BREF).
Measured: Baseline, after 8 weeks (post-intervention), and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 May 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Participants will be randomly assigned to one of three parallel groups: a face-to-face nursing care group based on the Salutogenesis Model, a virtual reality-supported nursing care group using the same model, or a control group receiving usual care. All groups will be followed concurrently, and participants will remain in their assigned group throughout the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERVE EKİN KILIÇASLAN, TC Erciyes University
- Investigators
- HANDAN ZİNCİR, PhD, Study director, Erciyes University, Faculty of Health Sciences, Department of Public Health Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816731
- Sponsor's protocol ID
- SM-DEMENTİA-VR-2025
- Acronym
- SM-VR-DEMENTIA
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical considerations, the sensitive nature of the study population, and privacy concerns.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07816731
- Acronym / sponsor ID
- SM-VR-DEMENTIA / SM-DEMENTİA-VR-2025
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 14 Sep 2026 (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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: a face-to-face nursing care group based on the Salutogenesis Model, a virtual reality-supported nursing care group using the same model, or a control group receiving usual care. All groups will be followed concurrently, and participants will remain in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face Salutogenesis Model-Based Nursing Care | Experimental | Behavioral: Face-to-Face Salutogenesis Model-Based Nursing CareParticipants 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. |
| Virtual Reality-Supported Salutogenesis Model-Based Nursing Care | Experimental | Behavioral: Virtual Reality-Supported Salutogenesis Model-Based Nursing CareParticipants 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. |
| Usual Care (Control Group) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- -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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Face-to-Face Salutogenesis Model-Based Nursing CareNursing 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. | Behavioural | Face-to-Face Salutogenesis Model-Based Nursing Care |
| Virtual Reality-Supported Salutogenesis Model-Based Nursing CareNursing 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. | Behavioural | Virtual Reality-Supported Salutogenesis Model-Based Nursing Care |
Primary outcome
Sense of Coherence
Time frame: 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.
1 secondary outcome
Quality of Life (WHOQOL-BREF)
Time frame: Baseline, after 8 weeks (post-intervention), and 3 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical considerations, the sensitive nature of the study population, and privacy concerns.
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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.
HANDAN ZİNCİR, PhD study director
Erciyes University, Faculty of Health Sciences, Department of Public Health Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-Face Salutogenesis Model-Based Nursing Care and Virtual Reality-Supported Salutogenesis Model-Based Nursing Care in people with Dementia, run by TC Erciyes 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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sense of Coherence (time frame: Baseline, after 8 weeks (post-intervention), and 3 months after the intervention). 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 6 Oct 2026.