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Effects of Snoezelen Multisensory Therapy on Older Adults With Dementia (SMT)

12 czerwca 2026 zaktualizowane przez: University of Primorska

Randomized Controlled Trial on the Effects of Snoezelen Multisensory Therapy on Behavioral, Psychological, and Physiological Symptoms in Older Adults With Dementia

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Słowenia
      • Portorož, Słowenia, 6320
        • Center for Older Adults Lucija

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Snoezelen Multisensory Therapy
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.
Inne nazwy:
  • SMT
  • Śnieżka
  • MSS
  • Multisensory stimulation
Behawioralne: Standard Therapy
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.
Inne nazwy:
  • Św
  • Terapia zajęciowa
  • Trening poznawczy
  • Rutynowa pielęgnacja
  • Group Social Engagement
Aktywny komparator: 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.
Behawioralne: Standard Therapy
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.
Inne nazwy:
  • Św
  • Terapia zajęciowa
  • Trening poznawczy
  • Rutynowa pielęgnacja
  • Group Social Engagement

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in agitation level as measured by Cohen-Mansfield Agitation Inventory (CMAI)
Ramy czasowe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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)
Ramy czasowe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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)
Ramy czasowe: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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
Ramy czasowe: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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
Ramy czasowe: Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total)
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)
Ramy czasowe: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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
Ramy czasowe: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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)
Ramy czasowe: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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
Ramy czasowe: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Primorska

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 sierpnia 2023

Zakończenie podstawowe (Rzeczywisty)

1 sierpnia 2024

Ukończenie studiów (Rzeczywisty)

1 sierpnia 2024

Daty rejestracji na studia

Pierwszy przesłany

21 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

18 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • UPrimosrka
  • 0120-104/2020/6 (Inny identyfikator: Slovenian National Medical Ethics Committee)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data (IPD) will not be shared due to ethical and privacy considerations, as the dataset contains sensitive information from vulnerable populations.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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