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

NCT07816731 | Recruiting

• 1 other identifier: SM-DEMENTİA-VR-2025
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, after 8 weeks (post-intervention), and 3 months after the intervention

Secondary Outcomes (1)

• Quality of Life (WHOQOL-BREF)

  Baseline, after 8 weeks (post-intervention), and 3 months after the intervention

Study Arms (3)

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.

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.

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.

Interventions

Face-to-Face Salutogenesis Model-Based Nursing Care BEHAVIORAL

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.

Face-to-Face Salutogenesis Model-Based Nursing Care

Virtual Reality-Supported Salutogenesis Model-Based Nursing Care BEHAVIORAL

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.

Virtual Reality-Supported Salutogenesis Model-Based Nursing Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Niğde/Bor

Niğde, Bor, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• HANDAN ZİNCİR, PhD

  Erciyes University, Faculty of Health Sciences, Department of Public Health Nursing

  STUDY DIRECTOR

Central Study Contacts

MERVE E KILIÇASLAN, Registered Nurse

CONTACT

+90 555 176 15 93; merveekinaka@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking Description Group allocation will be performed by an independent researcher to minimize allocation bias. While the investigator conducts the intervention sessions, the statistical analysis will be carried out by an independent analysis team who will be blinded to group assignments. All data will be coded, and the analysts will have access only to anonymized datasets, ensuring that group identity is not known during the analysis process.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: May 15, 2026
• Primary Completion: September 15, 2026
• Study Completion: September 15, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)