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| ID | Type | Description | Link |
|---|---|---|---|
| 0120-104/2020/6 | Other Identifier | Slovenian National Medical Ethics Committee |
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This randomized, controlled, longitudinal clinical trial investigates the effects of Snoezelen Multisensory Therapy (SMT) as an adjunct to standard therapy (ST) in older adults with dementia. Sixty participants with mild to moderate cognitive impairment and behavioral and psychological symptoms of dementia (BPSD) will be recruited from the Center for Older Adults Lucija (Slovenia). Participants will be randomized into two groups: control (ST) and experimental (ST + SMT). SMT will be administered 3 times per week for 12 weeks. Primary outcomes include changes in agitation (CMAI), depression (CSDD), anxiety (HADS), physiological indicators (heart rate, HR variability, SpO2, skin conductance, salivary cortisol), and frequency of psychiatric medication use. Subjective well-being will also be tracked before and after each session.
Dementia is a growing public health concern, with high rates of behavioral and psychological symptoms (BPSD), such as depression, agitation, and anxiety. Non-pharmacological therapies like Snoezelen Multisensory Therapy (SMT) are increasingly explored as safe and effective alternatives or complements to standard therapy (ST).
This randomized controlled clinical trial will evaluate the acute and chronic effects of SMT in 60 patients with dementia at the Center for Older Adults Lucija, Slovenia. Participants will be stratified by medication use and cognitive status and randomly assigned to either an experimental group receiving SMT + ST, or a control group receiving ST alone. SMT consists of 30-minute sessions in a multisensory room equipped according to Snoezelen® guidelines. Sessions will be personalized and monitored, including physiological measurements before and after therapy.
Primary outcomes will include changes in BPSD measured by the Cornell Scale for Depression in Dementia (CSDD), the Hospital Anxiety and Depression Scale (HADS), and the Cohen-Mansfield Agitation Inventory (CMAI). Physiological indicators such as heart rate (HR), heart rate variability (HRV), oxygen saturation (SpO2), skin conductance, and salivary cortisol will be collected before and after the 1st and 36th sessions. Medication use (PRN) will be tracked every two weeks.
The study includes translation and validation of BPSD assessment tools into Slovenian. Results are expected to contribute valuable data to the field of dementia care and support broader implementation of SMT in geriatric settings. This study was registered retrospectively on ClinicalTrials.gov after study completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMT + Standard Therapy | Experimental | Participants in this group will receive standard therapy routinely provided at the care center in addition to Snoezelen Multisensory Therapy (SMT). SMT will be delivered individually in a Snoezelen-designed multisensory room for 30 minutes, three times per week, over a 12-week period. Sessions will be tailored to each participant's sensory profile and preferences. |
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| Standard Therapy Only | Active Comparator | Participants in this group will receive standard therapy routinely provided at the care center, including cognitive stimulation activities (e.g., memory games, orientation exercises, attention and problem-solving tasks), group social interactions, occupational therapy, physical therapy, creative activities (e.g., art and music sessions), reminiscence therapy, and relaxation practices. No Snoezelen Multisensory Therapy (SMT) will be provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Snoezelen Multisensory Therapy | Behavioral | A non-pharmacological, individualized sensory stimulation therapy delivered in a Snoezelen-designed multisensory environment. Sessions include visual, auditory, tactile, and olfactory stimuli tailored to the participant's sensory profile and preferences. The intervention is delivered individually for 30 minutes, three times per week, over a 12-week period and is intended to reduce behavioral and psychological symptoms of dementia and improve well-being. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in agitation level as measured by Cohen-Mansfield Agitation Inventory (CMAI) | The Cohen-Mansfield Agitation Inventory (CMAI) is used to measure the frequency of agitated behaviors in elderly participants with dementia. Scores range from 29 to 203, with higher scores indicating more frequent agitation. | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12 |
| Change in depressive symptoms as measured by Cornell Scale for Depression in Dementia (CSDD) | The CSDD assesses signs of depression in individuals with dementia. Scores range from 0 to 38, with higher scores indicating more severe depression. | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12 |
| Change in anxiety level (HADS-Anxiety Subscale) | HADS-A is a validated subscale that measures anxiety in older adults. Scores range from 0 to 21, with higher values indicating greater anxiety. | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12 |
| Change in heart rate | Heart rate is measured using wearable physiological sensors as an indicator of autonomic arousal and physiological response. | Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12) |
| Change in subjective well-being using a self-reported analog scale | Participants report their mood, comfort, and overall well-being on a self-reported visual analog scale ranging from 0 to 5 before and after each SMT session. | Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total) |
| Change in heart rate variability (HRV) |
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Inclusion Criteria:
Age 65 years or older
Diagnosed dementia (any subtype)
Montreal Cognitive Assessment (MoCA) score between 10-25
Katz Performance Status Score (KPSS) between 10-24
Behavioral and psychological symptoms of dementia (BPSD), indicated by at least one of the following:
Cornell Scale for Depression in Dementia (CSDD) score >10
Hospital Anxiety and Depression Scale (HADS) score >8
Cohen-Mansfield Agitation Inventory (CMAI) showing moderate or severe symptoms
Ability to follow basic instructions and communicate needs
Written informed consent obtained from the participant or their legal representative
Exclusion Criteria:
Severe visual or hearing impairments
Inability to communicate in Slovenian
Concurrent participation in psychotherapy or physiotherapy
Diagnosis of epilepsy
Changes to psychiatric medication within 4 weeks prior to study start
Any other condition that, in the opinion of the research team, would interfere with participation or data collectio
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Older Adults Lucija | Portorož | 6320 | Slovenia |
Individual participant data (IPD) will not be shared due to ethical and privacy considerations, as the dataset contains sensitive information from vulnerable populations.
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D001519 | Behavior |
| D060825 | Cognitive Dysfunction |
| D011595 | Psychomotor Agitation |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D000091942 | Cognitive Training |
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Participants will be randomly assigned to one of two parallel arms. The intervention arm will receive Snoezelen Multisensory Therapy (SMT) in addition to standard therapy.
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No parties are blinded in this study due to the nature of the intervention.
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| Standard Therapy | Behavioral | Standard therapy refers to routine care provided in the residential care setting and includes cognitive stimulation activities, group social interactions, occupational therapy, physical therapy, creative activities (e.g., art and music sessions), reminiscence therapy, and relaxation practices. These interventions are delivered by trained staff as part of the regular care program. No Snoezelen Multisensory Therapy or other multisensory stimulation interventions are provided as part of standard therapy. |
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Heart rate variability (HRV) is measured using wearable physiological sensors as an indicator of autonomic nervous system regulation and physiological response to therapy. |
| Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12) |
| Change in skin conductance | Skin conductance is measured using wearable physiological sensors as an indicator of autonomic arousal and stress response | Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12) |
| Change in oxygen saturation (SpO₂) | Peripheral oxygen saturation (SpO₂) is measured using wearable physiological sensors as an indicator of oxygenation status during therapy. | Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12) |
| Change in salivary cortisol concentration | Salivary cortisol concentration is measured as a physiological biomarker of stress and hypothalamic-pituitary-adrenal (HPA) axis activity. | Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12) |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |