Effects of Snoezelen Multisensory Therapy on Older Adults With Dementia (SMT)
Randomized Controlled Trial on the Effects of Snoezelen Multisensory Therapy on Behavioral, Psychological, and Physiological Symptoms in Older Adults With Dementia
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Portorož, Slovinsko, 6320
- Center for Older Adults Lucija
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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:
- Acute psychiatric illness or unstable somatic condition
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: SMT + Standard Therapy
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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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.
Ostatní jména:
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.
Ostatní jména:
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Aktivní komparátor: Standard Therapy Only
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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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in agitation level as measured by Cohen-Mansfield Agitation Inventory (CMAI)
Časové okno: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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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.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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Change in depressive symptoms as measured by Cornell Scale for Depression in Dementia (CSDD)
Časové okno: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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The CSDD assesses signs of depression in individuals with dementia.
Scores range from 0 to 38, with higher scores indicating more severe depression.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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Change in anxiety level (HADS-Anxiety Subscale)
Časové okno: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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HADS-A is a validated subscale that measures anxiety in older adults.
Scores range from 0 to 21, with higher values indicating greater anxiety.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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Change in heart rate
Časové okno: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Heart rate is measured using wearable physiological sensors as an indicator of autonomic arousal and physiological response.
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Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Change in subjective well-being using a self-reported analog scale
Časové okno: Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total)
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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.
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Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total)
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Change in heart rate variability (HRV)
Časové okno: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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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.
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Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Change in skin conductance
Časové okno: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Skin conductance is measured using wearable physiological sensors as an indicator of autonomic arousal and stress response
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Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Change in oxygen saturation (SpO₂)
Časové okno: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Peripheral oxygen saturation (SpO₂) is measured using wearable physiological sensors as an indicator of oxygenation status during therapy.
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Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Change in salivary cortisol concentration
Časové okno: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Salivary cortisol concentration is measured as a physiological biomarker of stress and hypothalamic-pituitary-adrenal (HPA) axis activity.
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Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Aberantní motorické chování u demence
- Neurologické projevy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Duševní poruchy
- Symptomy chování
- Neurobehaviorální projevy
- Neurokognitivní poruchy
- Poruchy kognice
- Dyskineze
- Psychomotorické poruchy
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Kognitivní dysfunkce
- Deprese
- Demence
- Psychomotorická agitace
- Chování
- Správa zdravotnických služeb
- Kvalita zdravotní péče, přístup a hodnocení
- Terapeutika
- Kvalita zdravotní péče
- Ukazatele kvality, zdravotní péče
- Péče o pacienty
- Zdravotní služby
- Zdravotnická zařízení pracovní síla a služby
- Rehabilitace
- Následná péče
- Kontinuita péče o pacienty
- Neurologická rehabilitace
- Standard péče
- Kognitivní trénink
- Pracovní lékařství
Další identifikační čísla studie
- UPrimosrka
- 0120-104/2020/6 (Jiný identifikátor: Slovenian National Medical Ethics Committee)
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