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-three 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 63 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
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.
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.
Center for Older Adults Lucija
Portorož, Slovenia
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.
Time frame: 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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
Change in anxiety and depression level measured with the Hospital Anxiety and Depression Scale (HADS)
HADS is a validated subscale that measures anxiety and depression in older adults. Scores range from 0 to 21, with higher values indicating greater anxiety.
Time frame: 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.
Time frame: 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 1 to 5 before and after each SMT session.
Time frame: Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total)
Change in heart rate variability (HRV)
Heart rate variability (HRV) is measured using wearable physiological sensors as an indicator of autonomic nervous system regulation and physiological response to therapy.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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